‘ 4 J... ..|.. . .. .. . .l. <3 , «x... ,7 :g‘.n...‘.vu§$ ~ch. I‘ .. 2‘. p 1:»...- v , a. . Z1...- .. .3. . ‘ .. . n .5. . ...r12..: Iii... ...... ... 3.3;... . . m y . . n... u .s. .3... I :a‘ I]: \ . 1" .b .V . .f.f:}.1.7.. 1.—.:.3...pu . .0) v z . 1% I (704 1 5 IATE EUNIVERSITY [IBRARIES I 1.13%.. i Michigan State University IIIIIIIII IIII I.IIIIIIIIII III II 1293 00575 2690 This is to certify that the thesis entitled PERCEIVED CONTROL OVER THE MENOPAUEE EXPERIENCE AND EXPERIENCES, EXPECTATIONS AND BEHAVIORS REGARDING MENOPAUSE presented by _ I Jill (Walther) Kroll has been accepted towards fulfillment of the requirements for M.A. degree in Psychology Major professor Date April 2|. I989 0-7639 MS U is an Affirmative Action/Equal Opportunity Institution PLACE IN RETURN BOX to remove this checkout from your record. TO AVOID FINES return on or before date due. DATE DUE DATE DUE DATE DUE II C 2 8 I993. J ” “’4'“ I; “3’. 2 5mm H I997 “$19th : 3 i“ 3003 MSU Is An Affirmative Action/Equal Opportunity Institution PERCENED CONTROL OVER THE MENOPAUSE EXPERIENCE AND EXPERIENCES, EXPECTATIONS AND BEHAVIORS REGARDING MENOPAUSE By Jill (Walther) Kroll A THESIS Submitted to Michigan State University in partial fulfillment of the requirements for the degree of MASTER OF ARTS Department of Psychology 1989 ABSTRACT PERCENED CONTROL OVER THE MENOPAUSE EXPERIENCE AND EXPERIENCES, EXPECTATIONS AND BEHAVIORS REGARDING MENOPAUSE By 1111 (Walther) Kroll The purpose of this research was to determine the correlates of perceived control relating to menopause for use in developing an educational interven- tion to aid women in active involvement in their menopausal health care. Two hundred sixty nine women age 45 to 55 responded to written ques- tionnaires relating to menopause. High internal perceived control was found to correlate -.24, (p_ < .05), with experienced symptoms, and -.35, (p_< .05), with symptoms expected by those not yet experiencing menopause. Women whose periods were still regular perceived more internal control relating to meno- pause than women whose last period was 3 to 12 months ago, @(3, 263) = 4.92; p < .05). Women who scored higher in knowledge of menopause perceived more internal control related to menopause than did women who scored lower. It was concluded that an intervention addressing women’s needs during meno- pause should be sensitive to the variation in perceived control among women as it relates to differing knowledge and symptoms experienced. Dedicated to John and our sons, David and Thomas ACKNOWLEDGMENTS Special thanks to the chair of my thesis committee, Dr. William S. Davidson, and my thesis committee members Dr. Esther Fergus, Dr. Raymond Frankmann, and Dr. Marilyn Rothert. Additional thanks to the Estrogen Replacement Therapy Study group at Michigan State University. iv TABLE OF CONTENTS Page LIST OF TABLES .................................................................................................. ix LIST OF FIGURES ................................................................................................. x Chapter 1 Problem Definition: Menopause and the Hormone Replacement Therapy Controversy .................... 1 Menopause ..................................................................................... 3 The Hormone Replacement Therapy (HRT) Controversy .................................................... 6 Review and Critique of the Literature ........................................... 10 Criteria for Evaluation Of Research .......................................... 10 Search Method ............................................................................. 12 Locus Of Control and Menopause ............................................ 12 Health Locus of Control Scales ................................................. 19 Control Research Relating to Women ...................................... 21 2 Method ................................................................................................ 26 Hypotheses ................................................................................... 26 Subjects ......................................................................................... 27 Setting ........................................................................................... 30 Design ........................................................................................... 30 Chapter Page 2 Instruments .................................................................................. 31 Perceptions of Menopause ................................................... 31 Sociodemographic ................................................................. 36 Menopausal Symptoms ........................................................ 36 Management of Symptoms .................................................. 37 Menopause Information ....................................................... 38 Judgment Cases ..................................................................... 38 Procedure ........................................................................................... 39 Subject recruitment ..................................................................... 39 Data Collection ............................................................................ 4O 3 Results ................................................................................................. 43 Evaluation of Hypotheses .......................................................... 43 Hypothesis 1 .......................................................................... 43 Hypothesis 2 .......................................................................... 45 Hypothesis 3 ....................................................... . .................. .45 Hypotheses 4 8r 5 .................................................................. 49 Hypothesis 6 .......................................................................... 50 Hypothesis 7 .......................................................................... 50 Hypothesis 8 .......................................................................... 56 Hypothesis 9 .......................................................................... 56 Additional Analyses ................................................ : .................. 56 Summary ...................................................................................... 61 4 Discussion .......................................................................................... 63 Chapter Page 4 Limitations ......................................................................................... 68 Future Directions .............................................................................. 69 LIST OF REFERENCES ...................................................................................... 71 APPENDICES ...................................................................................................... 79 APPENDIX A Instructions to Participants .............................................................. 79 APPENDIX B Sociodemographic Instrument ........................ ' ................................ 8 2 APPENDIX C Menopausal Symptoms Instrument ............................................... 89 APPENDIX D Management of Symptoms Instrument ......................................... 98 APPENDIX E Menopause Information Instrument ............................................ 103 APPENDIX F Judgment Cases Instrument .......................................................... 107 APPENDIX C Perceptions of Menopause Instrument ........................................ 127 APPENDIX I-I Equations for Management Scales ................................................ 132 Example Calculations ..................................................................... 137 APPENDIX I Menopause Information Instrument Key .................................... 138 APPENDIX I Press Release and Media Requests for Participants ................... 139 APPENDIX K Participant Recruitment Letters .................................................... 141 vii Chapter Page APPENDIX L Participant Sign-up Sheet ............................................................... 143 APPENDIX M Newsletter Example ........................................................................ 144 APPENDIX N Additional Information Packet ..................................................... 145 APPENDIX 0 Consent Form .................................................................................. 148 APPENDIX P Introduction Sheet and Results Request Form ........................... 149 APPENDIX Q Example Thank-you Letters .......................................................... 150 APPENDIX R Calculation of Omega-squared ((02): An Estimate Of Treatment Effect Magnitude .................................................... 153 APPENDIX S Calculation of Correction for Unreliability ................................. 154 LIST OF TABLES Table Page 1 Locus of Control in Lien (1981) Study ....................................... 17 2 Description of the Participant Sample ....................................... 29 3 Perceptions Instrument Items ..................................................... 32 4 Interscale Correlations for Perceptions Instrument ................. 34 5 Education and Mean Score on Perceived Control ................... 45 6 Summary Statistics for Perceived Control and Last Menstrual Period ............................................................ 47 7 Summary Statistics for Symptom Management and Perceived Control ................................................................... 51 8 Medication Strategies and Frequencies ..................................... 52 9 Diet Strategies and Frequencies ................................................. 53 10 Vitamins and Minerals Strategies and Frequencies ................ 55 11 ”Other” Strategies and Prequencies......................- ..................... 55 12 Pearson Correlation CoeffiCient Matrix ..................................... 58 LIST OF FIGURES Figure Page 1 Distribution of Scores on Control Scale .................................... 35 2 Mean Perceived Control By Last Period ................................... 48 Chapter 1 Prl fini'nzMen u nhHrmne Replagmgnt Therapy Controversy Because of an increased life span, 95% of women today will live beyond menopause (Hamilton 8: Clements, 1982) making menopause a nearly univer- sal experience for American women. Up to 88% Of women experience symp- toms such as hot flashes (Feldman, Voda 8: Gronseth, 1985). Following meno- pause, women may be more prone to debilitating fractures of the spine, hip or wrist, due to accelerated loss of bone mass, (National Institutes of Health Consensus Development Panel on Osteoporosis [NIH], 1984). Symptom management and prevention of osteoporosis are therefore important issues for middle years women (Kirkpatrick 8: Edwards, 1985; Hallal, 1985) but women have been found to lack information regarding menopause (LaRocco & Polit, 1980). Since many of the issues surrounding management of symptoms and prevention of osteoporosis are complex, support and information groups ad- dressing the concerns of menopausal women have emerged in the United States and Europe (Schmid—Heinisch, 1985; Caldwell, 1982; Drennan 8: McGeeney, 1985; Staff, 1986), but no controlled studies Of the effectiveness of such groups have been reported in the literature to date. Preparation for the development of an educational intervention addressing the needs of meno- pausal women involves an understanding of current perceptions and concerns regarding the issues related to menopause today. One issue which may add to our understanding of how women view menopause is perceived control. 2 Perceived control has been found to be related to a variety Of health related be- haviors (Strickland, 1978) and may be an important variable to understand re- lating to the experience of menopause for women. Duffy (1988) found that health locus of control accounted for 16% of the variance observed in health promotion lifestyle among a convenience sample of 262 middle years women. Additionally, it has been found that individuals may differ in the level of con- trol they desire to have in regard to their health care (W allston, Smith, Wallston, King, Rye 8: Heim, 1987). In a review of locus of control and health Wallston, Smith, Wallston, King, Rye and Heim (1987) concluded that health education programs which tailor the orientation of the program to internally or externally-oriented individuals were more effective in changing targeted health behaviors. In our youth-oriented society (Rosenthal, 1979) the period Of midlife has often been overlooked in the study of the human life cycle (Upheld 8: Susman, 1981). Today, at the time of menopause a woman still has one third of her life left to live (Schmid-Heinisch, 1985). Included in the period between the birth Of a woman’s last child and old age, is the transition from the reproductive phase of the woman's life to the nonreproductive phase (Rosenthal, 1979). This life stage, which includes the menopause, is a time of physical and psychosocial change which may be accompanied by uncomfortable physical or psychological symptoms for some women (U phold 8: Susman, 1980). To fully understand the context in which the issues related to menopause and the mid- dle years are experienced it is necessary to understand the physical, psycholog- ical and social changes occurring during this time. Menopause ”Menopause" means the cessation Of menses (Rosenthal, 1979; Feldman et al, 1985). The ”climacteric" has been described as ”that phase in the aging process Of women making the transition from the reproductive stage of life to the nonreproductive stage” (Rosenthal, 1970, p. 358), ” a natural life phase, occurring in all women as the ovaries cease production and the estrogen level decreases permanently” (Dosey 8: Dosey, 1980, p. 14). ”Climacteric symptoms” were defined by Uphold 8: Susman (1981) as ”the common physiological and psychological identifiable complaints associated with the gradual regression of the ovarian hormonal function,” p. 85. A related term, ”menopause transition,” has been described as ”a period of time marked by a progressive change in the pattern of menstrual cyclicity indicated by unusually long or short menstrual cycles, diminished menstrual flow, or intermittent menstrual cycles that terminate in menopause” (Feldman et al, 1985, p.262). ”Perimenopausal” has been defined as, ”a period of time surrounding the actual experience of meno- pause” (Feldman et al, 1985, p. 262). Although some studies have included def- initions Of menopause, many have not and a woman’s status in regard to meno- pause is Often unclear leading to confusion in the menopause literature (Alexander 8: Roberts, 1987). There are difficulties in determining a woman’s menopausal status since menopause can only be diagnosed retrospectively (after menstrual periods have ceased) without measurement of hormone levels (World Health Organization [WHO], 1981). The physical changes which occur at menopause have been postulated to be due to ovarian aging. By the time a human female is born she has all of the 4 oocytes that she will have in her lifetime. These oocytes degenerate at various stages of follicular development, beginning prenatally and continuing through- out the woman’s lifetime, (less than .01% of oocytes in women are ovulated). When all of the oocytes have either degenerated or been ovulated ovarian failure occurs (Gosden, 1985). Since the somatic cells which surround an oocyte and make up the follicle are the source of follicular oestradiol, when the store Of oocytes and follicles is depleted, the ovary ceases to produce estrogen and menopause occurs (Gosden, 1985). The mean age at natural menopause is about 49.5 years, but 30 percent of women cease menstruating due to surgery (Krailo 8: Pike, 1983). Estimates of the mean age of menopause vary from 46.7 to 50.1 (Batrinos, Panitsa-Faflia, Pitoulis, Pavlou, Piaditis, Alexandridis, 8: Liappi, 1979; Van Keep, Brand, 8: Lehert, 1979; Feldman et al, 1985). Menopausal symptoms vary greatly among women. For slightly less than half of women, menses cease abruptly, while for others, cessation of menses follows a period of menstrual irregularity (Batrinos et al, 1979). For women who experience menstrual irregularity, the period of irregularity lasts less than 1 year for almost 90% of the women, but continues for up to 2 years for about 10% of the women, (Batrinos et al, 1979). Accompanying the changes in the menstrual cycle are a variety Of symptoms including but not limited to hot flashes, vaginal dryness, headaches, weight gain, aches in the back Of the neck and skull, trouble sleeping, depression, forgetfulness, irritability and tiredness, tingling in limbs, joint aches, night sweats, shortness Of breath, dizziness, palpi- tations, loss of appetite, aching breasts, backache, bladder difficulties, and sexu- al problems (Babuna, Aksu, 8: Erez, 1982; Feldman, Voda, 8: Gronseth, 1985; 5 Iaszmann, van Lith, 8: Zaat, 1969; Bungay, Vessey, 8: McPherson,, 1980, Dosey 8: Dosey, 1980). The withdrawal of estrogen which was being produced by the ovaries prior to menopause results in changes to estrogen-sensitive tissues like the vagina. The vagina is gradually shortened and has reduced compliance to applied force following the withdrawal Of estrogen (Gosden, 1985). The uterus, cervix and vulva also show estrogen withdrawal related changes (Gosden, 1985). Among the symptoms reported by women during the menopause, hot flashes has been the most frequently reported complaint (Polit 8: LaRocco, 1980). The incidence of hot flashes has been estimated to be between 40% and 90% (Batrinos et al, 1979; Iaszmann, van Lith 8: Zaat, 1969; Feldman et al, 1985). Hot flashes were defined by Feldman et a1 (1985) as an experience associated with the menopause transition, characterized as vasomotor instability, resulting in a sudden sensation Of heat or a feeling as perceived and determined through the self-report of women. Nonthermal body sensations may also be described including sensations of tingling, throbbing, rush of blood, lightheadedness, chills, and suffocation (Feldman et al, 1985). Finally, in addition to experiencing physical and psychological symptoms during menopause, many women are faced with social changes as well, such as a changing family and marital role due to children achieving adulthood (Bungay et al, 1980), financial difficulties, employment changes, and body changes due to aging (Lien, 1981). Which of the symptoms experienced by a woman are directly attributable to menopause remains unclear (Greene, 1976). There is evidence that vasomo- 6 tor symptoms and symptoms associated with changes in estrogen sensitive tis- sues may be directly attributable to the decline in estrogen associated with menopause (Jaszmann et al, 1969; Bungay, et a1, 1980). Other symptoms may be related to psychosocial changes which occur at midlife or may have other or- igins and are not unique to menopause (Bungay, et al, 1980; Ballinger, 1985). H rm n R l m n Th n One of the most popular treatments for menopausal symptoms today is hormone replacement therapy (HRT), also called estrogen replacement therapy or ERT (National Center for Health Statistics, 1983; American Medical Association Council on Scientific Affairs [AMA Council], 1983). Estrogen was first prescribed for menopause-related symptoms in the United States in 1929 (Furuhjelm, 1977) and has usually been prescribed as one of two regimens: es- trogen alone, or estrogen/ progestin combined (Upton, 1980). Controversy exists regarding whether estrogen is an appropriate treatment for the problems of menopause. It has been put forth that an alternative causal explanation for osteoporosis in Older women is poverty-induced low-calcium diets and fear of walking alone in a violent society (MacPherson, 1985, 1987). Estrogen has been seen by some as contributing to the perception of meno- pause as a deficiency disease, rather than an adaptive life event (Alington- MacKinnon 8: Troll, 1981). Estrogen has also been seen as a beneficial treatment for problems experienced by some women during menopause. Estrogen replacement therapy has been found to be highly effective in reducing the frequency of hot flashes (by 91 %) when compared with a placebo (Judd, 1987) and was concluded to be the single most effective modality for the 7 prevention of osteoporosis in women by the National Institutes of Health Consensus Development Panel on Osteoporosis (1984). The issue is of concern because of the severity of the problem of osteoporosis. Osteoporosis is an age-related disorder characterized by decreased bone mass and increased susceptibility to fractures in the absence of other recognizable causes of bone loss (NIH, 1984). Osteoporosis has been estimated to affect as many as 20 rnillien individuals in the United States and about 1.3 million fractures per year in people age 45 and older have been attributed to osteoporosis (NIH, 1984). The cost of osteoporosis in the United States was estimated to be $3.8 billion per year, in 1984 (NIH, 1984). A significant number of those who experience fractures die from complications directly associated with the fracture (NIH, 1982). Ne laboratory tests for defining individuals at risk or those with mild osteoporosis are available (NIH, 1984) so a decision regarding whether to take estrogen replacement therapy must be made based on risk factors. It has been clearly documented that unopposed pestrnenepausal estrogen use increases the risk for endometrial cancer from 1 case per 1,000 women to between 3 and 7 cases per 1,000 women (Persson, et al, 1989; Gastel, Cerneni-Huntley 8: Brody, 1980; Hulka, Kaufman, Fowler, Crimson 8: Greenberg, 1980). The addition of the hormone progesterone to the estrogen treatment regimen has been found to reduce the risk of endometrial cancer to the rate for non-estrogen users (Gambrell, 1987; Persson, et al, 1989; Gambrell, 1978) but when administered cyclically in the dose believed to be required to provide protection from en- dometrial cancer may promote a resumption of monthly bleeding or spotting (Luciano, Turksoy, Carlee 8: Hendrix, 1988; Jones, Francis 8: Nerdin, 1982). 8 Estrogen replacement therapy may also provide protection from coronary heart disease in women, by reducing serum levels of low density lipepretein (LDL) cholesterol (Wolfe 8: Huff, 1989; Henderson, Paganini-Hill 8: Ross, 1988) and increasing levels of high density lipepretein cholesterol (Fahraeus, 1988). The addition of pregestins to the therapy may have the opposite effect however, and may actually increase the risk for coronary heart disease (La Rosa, 1989). Finally, evidence regarding the relationship between I-IRT and breast cancer re— mains unclear and may be dose related (Dupent, Page, Rogers 8: Parl, 1989). Studies of death from all causes have suggested that women who used estrogen replacement therapy may be at less risk of death than women who did not (Bush et al, 1983). In summary, the issues facing women today at the menopause are complex, with risks as well as benefits inherent in the decision regarding HRT. All of the factors discussed above, discomfort from hot flashes, risk of fractures due to osteoporosis, risk of endometrial cancer, heart disease risks and all-cause mortality risks combine to create a dilemma for the woman as she approaches menopause. Should she rely entirely on the expert Opinion of her health care provider as to decisions regarding her menopausal health care, or should she take an active role in the decision making? If she chooses to take an active role, how will she weigh the various risks and benefits? Many women will want to take an active role in the decision making and will wish to be inferrned regarding the risks and benefits associated with estrogen replace- ment therapy. Other women will desire a lesser degree of involvement in the decision making. Wallston, et al (1987) found that not all individuals desired the same degree Of involvement in or ”control” regarding their health care. 9 Control relating to menopause may therefore be an important variable to understand as it relates to the woman’s participation in her menopausal health care. Perceived control, also called locus of control was first described by Rotter (1966). Locus of control was said to refer to an individual’s generalized expectations about how reinforcement is controlled (Rotter, 1966). Individuals who perceived events as occurring as the result of luck or powerful others, or as unpredictable, were said to maintain an external locus of control (Rotter, 1966). Those who believed that an event was contingent upon their own be- havior or characteristics maintained a generalized internal locus of control (Rotter, 1966). Control has been studied extensively in many different spheres or situations and a variety of situation-specific scales to measure control have been developed, including several particularly addressing health-related issues (W allston, Wallston, Kaplan 8: Maides, 1976; Long 8: Haney, 1986; Labs 8: Wurtele, 1986). Situation-specific measures of control have been found to provide enhanced prediction of behavior in specific situations (W allston, Wallston, Kaplan 8: Maides, 1976). Although many studies have addressed control as it related to health care issues, few previous studies have examined the relationship between control and experiences, expectations or behavior relating to menopause. Of the studies reported, many were found to have significant limitations or failed to address important issues relating to menopause such as knowledge of menopause, menopausal status or symptom management behavior. 10 Review and Critique of the Literature This section reviews previous studies of control as it relates to menopause. The conclusions of previous literature reviews will be described, along with criteria for future research. Following this, the literature search methodology will be described, and the studies will be discussed. Criteria for Evaluation of Regargh Several critiques of the general menopause literature have discussed the limitations of past research and delineated criteria for future research (Barnett 8: Baruch, 1978; Koesk, 1982; Perlmutter 8: Bart, 1982). Some research has been based on the assumption that menopause was a psychosocial stresser which stirred up previous psychosexual adjustments and produced turmoil and regression (the premorbid personality model). Research based on this model has been criticized because it has drawn study subjects from patient populations and used psychological testing, retrospective report and clinical observation to study menopause (Koeske, 1982). Research which could challenge such assumptions would draw study participants from non-patient populations and employ means other than clini- cal observation to gather data. Other research has been based on the assumption that stresses on women during their middle years has predisposed them to psychological difficulties (the coincidental stress model). Research based on this model was primarily anecdotal and based on case reports (Koeske, 1982). A general recommendation for future research indicated that research should involve aggregated data from multiple individuals. Additional l l difficulties with past research were discussed by Koeske (1982). Koeske (1982) saw research which was based on the Behavioral Science models of menopause as deficient because like the biomedical models, the research was usually seeking to explain non-normative phenomena and posit a simple 1 to 1 relationship between hormone deficiency and behavior, social environment (past or present) or social structure and experience. The recommendation to break out of this pattern was that future research should look for multiple and interacting variables as explanations for experience (Koeske, 1982). Also ignored by most behavioral science research on menopause has been the complex influence and interaction of biological factors (Woods, 1982; Koeske, 1982) and the way in which social-environmental factors (pastor present) can affect biology (Koeske, 1982). Perlmutter and Bart (1982) suggested that future research should look at the ways in which women understand and make sense of their experiences in order to go beyond models of menopause which see women as passively vic- timized by their hormones, psyches and society. In summary, future research dealing with menopause should draw study participants from non-patient pepulations, use other than clinical observations as a means of data collection, report aggregated data collected from large samples of women, look for multiple and interacting variables as explanations for observed variation, consider ways in which social-environmental factors can influence biology and examine the ways women themselves understand and make sense of their experiences. 12 There have also been recommendations for future research addressing locus of control. Rotter (1975) and Lowery (1981) suggested development of locus of control scales specific to various situations. It was believed that a measure of generalized expectancy would be less useful for making predictions in specific situations than a control scale designed to measure expectancies in that situation or a situation of the same subclass (Rotter, 1975) particularly if one is seeking a practical application of the information (Rotter, 1975). Search Methgd A computer search in August, 1987 of five databases resulted in 6 documents including 1 duplication. The key words used were ”menopause” combined with one of the following: ”internal-external-contrel,” or ”locus with control.” Of the 5 non-duplicates, 2 were dissertations. The databases searched were: Medline, (Index Medicus) (1), Dissertation Abstracts International (2), Psychological Abstracts (3-1 repeat), Social Science Citation Index (0), and Research in Nursing and Allied Health (0). The number in parentheses represents the number of documents from the preceding source. Of the 5 non- duplicated citations, one was irrelevant to the topic and 1 was a general review of research on women in the middle years and reported no research findings. Three relevant articles found through the search and an additional article found since the computer search were reviewed. They were critiqued with regard to the relationship between menopause and perceived control. Locus of Control and Menopause Collins, Hanson and Enereth (1983) examined the relationship between climacteric symptoms, response to hormonal replacement therapy, personality 13 characteristics and masculine and feminine self-concept. Masculine and feminine self-concept were measured by an instrument developed by the researchers. Study participants were 17 post-menopausal women selected by an unspecified means from among the patients attending an outpatient gynecology clinic. The women’s post-menopausal state was verified by measurement of FSH (follicle stimulating hormone) levels. Self-reports of vasomotor, psychosomatic, psychological and sleep-related symptoms were obtained using a graphic scaling technique with items adapted from the Blatt Menopausal Index and the Neugarten and Kraines check list and personality characteristics were measured by the Karelinska Scales of Personality questionnaire. Internal-external locus of control was measured by a questionnaire adapted from Rotter. The study sample scored higher on W (p < .05) “W (p < .05) than a non-patient sample of the same age did, but scores on masculinity / femininity were similar to those obtained by the researchers from female university students. Internal- external locus of control scores were higher than those obtained from female university students, indicating highflpercejyegw. The magnitude and statistical significance of the difference was not reported. After the instruments were administered, study participants were placed on a regimen of estregen/progestin on a 28 day cycle, and the same measures were administered again at 4-6 weeks after the start of the hormone treatment. memms Refer: treatment were found *9 correlated significantly with external locus of control Q = .48, p < .05), but psychosomatic, vasomotor and sleep-related symptoms were not. N one of the symptoms l4 correlated significantly with control after treatment. The authors warned that the results had to be interpreted with caution because some of the symptoms and the personality variables could have been measuring the same underlying dimension. Interpretation of these results was also limited by the small sample size, lack of a comparable comparison group and use of a patient sample with little descriptive information in regard to relevant characteristics in relation to the general population of women in this age group. Additionally, no explanation was given for the lack of findings post treatment, increasing suspicion that the single significant finding before treatment could have been due to chance. Lind (1984) examined the relationship between menopausal symptoms, use of estrogen replacement therapy and locus of control as measured by the Rotter internal-external locus of control scale. One hundred volunteers between the ages of 36 and 80 who were postmenopausal (reported that there had been no spontaneous menses for 12 months or more) completed a symptom checklist, the Rotter I-E scale and a sociodemographic questionnaira Sixty one percent had not had a hysterectomy, 25% had undergone a partial hysterectomy (only the uterus, not the ovaries had been removed) and 14% had undergone a complete hysterectomy involving removal of uterus and ovaries. Eifty percent of the participants were employed part or full-time and 80% had at least some college. Forty percent of the participants had annual incomes of $25,000 or more. . Women were categorized as ”High Internal Locus of Control" or ”High External Locus of Control” by splitting the scores on the LE scale at the median l 5 point and placing women who scored below the mean into the ”High Internal” group and those who scored above the mean in the ”High External” group. Women were also categorized according to whether they used estrogen or not, I producing 4 groups: High Internal Users of Estrogen, High Internal Non-users I of Estrogen, High External Users of Estrogen and High External Non-users of / Estrogen. C There was a significant difference (p < .05) between the four groups (Internal Non-users, Internal Users, External Non-Users and External Users) on number of symptoms reported. gmmalfion-gers of Estrgggn reported the most symptoms and IntemaLNen-JrserseLEstrogenreportedtheiemest Widnd (1984) found that while there were no differences in symptoms reported between estrogen users and non-users, there was a Smyflsmnsmfimpofled betweenbish-exteraalw of control subjects and highjntemallomseficontrel subjectsfy Lind (1984) found no relationship between locus of com—Ire] and the use of estrogen, (x2 = .002, p > .05). There was also no significant relationship (a between locus of control and age or income. ‘2. (.4 Li :4” (2') T I I {I I? The conclusion in this study was that the results supported the premorbid personality model of menopause-that menopausal symptomatology was psychological in origin, rather than being an estrogen deficiency disease. It was also concluded that Wntrol strgrglyinfluenced a woman’s reaction to W- While the Lind study used an adequate sample size, used a non-patient sample, and reported adequate reliability of the control instrument, the 16 measure of control was not situation-specific and so had limited practical application for drawing conclusions about women’s perceived control over their menopause experience. Lien (1981) studied the needs of middle aged adults in the Lutheran Church in Texas. Seven hundred seventy five men and women, aged 35 to 64, from 31 Lutheran congregations in Texas were randomly chosen to participate in the study. Of these, 218 agreed to participate. Data was collected by a written questionnaire and a group interview, held during a workshop at the participants’ church. Thirty four percent of the participants were aged 35 to 44, 43% were between the ages of 45 and 54, and 22% were between 55 and 64 years old. Sixty three percent (139) of the participants were women, and 91% of the participants were married. ”Locus of Control” was measured by 21 items on the questionnaire instrument. The origin of the items was unspecified. The internal consistency of the scale was not reported, but the ”validity” of the instrument was verified through pilot testing with middle aged adults and a panel of experts over age 35. The experts included a PhD. in Science Education, clergymen and lay people and ”members of the Christian community.” The items comprising the ”Locus of Centre ” scale are shown in Table 1. Lien (1981) used a non-patient sample of adequate size and developed a control scale specifically for the purpose of the study, but no measure of scale internal consistency was reported. Additionally, the construct validity of the control scale could be challenged. While it was reported that the instrument validity was addressed by having a panel of experts review the items, this l 7 appeared to address the relevance of the items to middle aged adults rather than to the construct of control. Table 1 Locus of Control items in Lien (1981) study Items There has been a change in my social activities. I have experienced the death of a close friend. I have experienced difficulties in demonstrating academic ability. I feel out of place in church activities. I have worried about whether a decision I made was the right one. I need someone to talk to. I am alone more than I like to be. I feel more at ease with people after I have an alcoholic drink. I have considered suicide. I have attempted suicide. 1 seem to dwell on the past. I do not feel free to do things I want to do. I feel free to do things I want to do. I feel that I am a useful person. I feel useless. I feel effective. I am not respected as an individual. I feel depressed. My life seems to have lost its meaning. I am satisfied with life. LDuffy (1988) studied 262 women (for a response rate of 44%) who responded to a mailed questionnaire relating to midlife health. The women ranged in age between 35 and 65, were predominantly white and 80% had college or graduate degrees.7fwenty five percent of the variance observed in a 18 total health promotion score (from the Health-promoting Lifestyle Profile) was explained by chance health locus of control, internal health locus of control (both from the Multidimensional Health Locus of Control Scale), self-esteem (from the Rosenberg Self-esteem Scale), current health, health worry/ concern, and post-high-school education. It was concluded that the findings supported Fender’s health promotion model which posited that individualpercepfions of health locusQnggtrngelfresteemy and health status influence health promotion behavior. It was concluded that highly educated midlife women would not want to leave their health to chance. \I The major short-coming of this study was the low response rate and homogeneity of the sample. Since the sample was self-selected the results could not be generalized to the population at large or to other women with similar sociodemographic characteristics. It did indicate however, that for at least some women, control was an important variable in relation to midlife health concerns. In summary, the literature to date suggested that there may be a relationship between locus of control and symptoms during menopause, with those experiencing more symptoms having an external locus of control. No relationship between control and estrogen use has been detected. Nor was a relationship found between control and any demographics studied. Some findings indicated that there may be agafionshiphetmeeg 9M1 and Egg- WEEIEYSE 91990859919: fiybglgllfifiMEsn- An examination of selected studies of health locus of control and control research relating to women provided information partially applicable to the 19 issue of control as it related to menopause. l h f n l 1 In a study of control which used the Health Locus of Control [HLC] scale, Wallston et al, (1976) found that high-value internals selected more pamphlets relating to a health condition about which they knew nothing than did other groups of individuals which suggested that health locus of control could be used to predict health related behavior such as information seeking. (”High- value” individuals ranked health as one of their top 4 terminal values). [5:37 In a second study, Wallston et a1 (1976) found that overweight women who attended an 8 week weightless program consistent with their expectancies as measured by the HLC were significantly more likely to be satisfied with the program than were women attending programs inconsistent with their expect- ancies. This finding indicated that control may be an issue in health related interventions such as a program addressing health care during menopause. The HLC has been one of the most frequently used scales for application to health-related situations. The HLC Scale consisted of 11 face-valid items in a 6 point Likert-type format with half of the items worded internally and half worded externally. The alpha coefficient of reliability has ranged from .40 to .72, depending on the sample and the test-retest reliability (8 week interval) was .71. The scale correlated -.01 with the Marlowe-Crowne Social Desirability Scale and .25 to .46 with Rotter’ 5 LE scale. Wallston et a1 (1976) found no sig- nificant differences between males and females on the HLC scale. The HLC scale has been found to be more predictive of health related behavior than the Rotter I-E scale (Wallston et a1, 1976). 20 In a review of research examining control and health Strickland (1978) indi- cated that measures specific to health such as the Wallston et a1 HLC scale were better predictors of health-related behaviors than were non-specific measures but concluded that the I-E variable (Internal-External) was only one of a num- ber of complex factors that may converge to predict health attitudes and behav- iors and that the variance that IE accounted for was fairly small in many situa- tions. Strickland concluded that although results were not unanimous, the bulk of the research suggested that internal individuals appeared to engage in more adaptive responses when faced with health problems than did externals and that development of an internal orientation could lead to improved health prac- tices. Wallston and Wallston (1978) in a review of locus of control and health, also concluded that health education programs should be tailored to locus of control beliefs since some education programs had been found to be differentially effective for internals and externals. They also concluded that since internals appeared more likely to engage in positive health behaviors health educators should train patients to hold more internal beliefs and that internal locus of control could be used in conjunction with behavioral measures to evaluate health education programs. This conclusion conflicted with the findings of Wallston et a1 (1987) who studied patients scheduled for a barium enema examination and found that low desire for control patients experienced less distress in an information only condition as compared to choice or predict- ability conditions. Contrary to prediction, high desire for control patients ex- perienced less distress in the predictability condition compared to the choice or information only conditions. It was hypothesized that this was due to reac- 2 l tance. The choice condition failed to provide a true choice and instead was per- ceived to be a travesty, providing a choice ”between poisons” (W allston et al, 1987). These results indicated that individuals differed in their desire for control and suggested that ' t rven 'ons should be tailored to the W ingr- m’gnals in regard to control. While there was disagreement as to whether an internal orientation relating to health should be encouraged or whether attempts should be made to accom- modate the individual’s internal or external orientation (Strickland, 1978; Wallston 8: Wallston, 1978; Wallston et al, 1987) there was general agreement that control was an important variable in health related issues and for application to health interventions. Control Research Relating to Women While Wallston et a1 (1976) reported no differences between men and women on the HLC scale, research relating health locus of control to situations specific to women’s health may be especially useful when considering control in relation to an issue such as menopause because of potential greater similarity between the situations. A study of women's choice of prenatal health provider supported the find- ing described above regarding differing desire for control. Women who had selected a nurse midwife scored significantly higher on the internal locus of control subscale of the Multidimensional Health Locus of Control [MI-ILC] scale than did women who had chosen an obstetrician. Women who chose an obstetrician scored more highly on the powerful other subscale. The two groups of women (N = 244) did not differ significantly on other variables such 22 as demographic characteristics, how long they had been pregnant, when they first sought prenatal care or rankings of life values (Aaronson, 1987). This sup- ported experimental data which suggested that women differed in the amount of control they desired over their health care. Also supporting this concept was a study by Littlefield and Adams (1987) which found that women who chose a conventional birthing method (versus an alternative birthing center) scored significantly higher (p < .01) on the powerful others subscale of the MHLC than did women who chose to birth at the alterna- tive birthing center. Littlefield and Adams (1987) also found that women did not score differently on the internal control subscale after delivery compared to prior to delivery, which suggested that internal control was a stable personality characteristic. Women in both birthing conditions did increase significantly in powerful others scores post delivery, which suggested that experience may in- fluence women’s perceptions regarding control relating to health. Since the findings found change on one control dimension (powerful others) after delivery but not on another dimension (internal control) it was unclear whether control was a personality characteristic or a situation specific variable. Since control may be situation specific or may change with experience, studies of control as it related specifically to menopause may be needed for practical application of the information. While this research may generalize to women and health during menopause, there are some differences to consider. First, while this research specifically examined control in relation to a health issue for women, the data may not generalize from prenatal care to menopausal care because the women belong to different age cohorts and some studies indicated 23 that some control dimensions were influenced by situation or experience. Menopause is not only a different situation, but is experienced by women at a different age than the women who were studied regarding childbirth. Both the general research conducted using the HLC scale, which used college students as subjects (W allston et al, 1976) and the studies related to childbirth health providers (Aaronson, 1987; Littlefield 8: Adams, 1987) studied women under the age at which menopause occurs. The Littlefield and Adams (1987) study described above showed that score on the powerful others subscale can change as a result of experience which also indicated that studies examining women at one age may not generalize to women at a different age. Secondly, the measure used (the MHLC) was a general measure of health locus of control. The more situation-specific a measure is the better it is expected to predict behavior (Rotter, 1975) suggesting that a measure developed specifically to measure con- trol relating to menopause may be more appropriate for applied use. Labs and Wurtele (1987) found that a measure developed specifically to assess control re- lating to fetal health significantly predicted maternal behavior, while the MHLC scale did not. For this reason it is important to examine locus of control as it relates specifically to menopause. Additional research is needed to verify the relationship between symptoms and control using a situation-specific measure and to look at the relationship between control and management of symptoms with estrogen therapy and other strategies. Additionally, sociodemographics should be examined using a situation-specific measure of control to determine whether women of different backgrounds differ significantly on control 24 relating specifically to menopause. Another topic which has not been addressed in the literature to date is whether a relationship exists between control and knowledge regarding menopause. Do these who are more knowledgeable about menopause perceive more or less control relating to menopause? Ferguson, Hoegh and Johnson (1989) found that knowledge regarding menopause issues was significantly related to likelihood of taking ERT and that women who were more likely to take ERT were more likely to view menopause as a medical condition and less likely to favor natural approaches to menopause. Is the perception of control relating to menopause dependent on a woman’s menopausal status as measured by last menstrual period? Do women perceive more or less control relating to menopause while they are actually experiencing the change in their menstrual pattern? Addressing these questions requires an instrument designed to measure perceived control which is situation-specific to menopause and has adequate internal consistency. It requires a non-patient sample of adequate size and a data collection measure other than clinical observation Aggregate data should be the basis of any conclusions drawn. The study described on the following pages aimed to describe one of the key variables in the experience of menopause-perceived control-and to correct some of the methodological flaws of past research on the menopause. The instrument developed for the study was designed for use with a non-patient sample and was designed to be situation-specific to the issue of control relating to menopause. The data collection method was self-report rather than clinical observation and a sufficiently large sample size was used to ensure adequate 25 statistical power in the analysis of the aggregate data. The methods, procedures and hypotheses for the study follow. 26 Chapter 2 M91 The purpose of this research was to determine the correlates of perceived control relating to menopause for use in developing an educational interven- tion to aid women in active involvement in their menopausal health care. Perceived control was examined in relation to demographic variables, symp- toms, knowledge about menopause, symptom management behavior, and like— lihood of taking hormone therapy. Emothexs 1. Marital status, employment, household income, and education will differentiate between individuals who are high in perceived control and those who are low in perceived control. 2. Religious preference will differentiate between individuals who are high in perceived control and those who are low in perceived control. 3. Menopausal status (as measured by time since last menstrual period-item 13 on Sociodemographic instrument) will differentiate between individuals who are high in perceived control and those who are low in perceived control. 4. Women who indicate experiencing or expecting more symptoms on the symptoms instrument will differ in perceived control from women who indicate fewer symptoms. 27 5. Women who indicate experiencing or expecting more severe symptoms on the symptoms instrument will differ in perceived control from women who indicate less severe symptoms. 6. Women who indicate a higher mean number of symptom management strategies on the management instrument will differ in perceived control from women who indicate a lower mean number. 7. Symptom management strategy category will differentiate between individuals who are high in perceived control and those who are low in perceived control. 8. Overall knowledge regarding menopause as measured by the Menopause Information Instrument will differentiate between individuals who are high in perceived control and those who are low in perceived control. 9. Mean likelihood of taking estrogen replacement therapy will differentiate between individuals who are high in perceived control and those who are low in perceived control. Subjects Two hundred eighty three women between the ages 45 and 55 (inclusive) completed instruments, of which 271 met the criteria for participation and had usable data. To meet the criteria for inclusion in the study, women were required to be between 45 and 55 years old, not presently taking estrogens and 28 not have had a hysterectomy. Twelve women were eliminated from data analysis because either they did not meet these criteria, or they failed to complete one or more entire instruments. The demographic characteristics of the sample are shown in Table 2. Participants were volunteers recruited through Lansing area churches, synagogues and women’s organizations and through newspaper and newsletter articles requesting participants and a television interview describing the study. Participants were also recruited through an article in the Detroit Free Press which reached women in the Detroit area and in other Michigan cities. Seventy of the participants attended a data collection session in the Detroit metropolitan area, and 201 participants attended sessions in the Lansing area. All of the participants were English- speaking and able to respond to written material. The sample consisted of women who volunteered to participate in this study and were told that they would received information about estrogen replacement therapy and menopause. The sample was not necessarily representative of the population of women in this age range, but was descriptive of a subsample who were interested in the topic and might be likely to attend an informational program on ERT and menopause. 29 Table 2 WWW Variable N % Last Menstrual Period Still Regular Periods 142 52.4% Less than 3 Months Ago 34 12.6% 3 --12 Months Ago 35 12.9% 12 or More Months Ago 58 21.4% Missing 2 .7% Marital Status Married 210 77.5% Divorced 38 14.0% Single 11 4.0% Widowed 10 3.7% Separated 1 .4% Missing 1 .4% Employment Status Employed Full Time 136 50.2% Employed Part Time 71 26.2% Not Employed, Retired or Other 64 23.6% Yearly Family Income $50,000/ yr or More 105 38.7% $35,000 - $49,999 55 20.3% $30,000 - $34,999 33 12.2% Less than $30,000 65 24.0% Missing 13 4.8% Education Less than 12 years 4 1.5% High School Graduate 61 22.5% More than 12 yrs. but no degree 67 24.7% Tech. School or Community College Degree or Other 21 7.8% Bachelors Degree 68 25.0% Masters Degree 42 15.5% Ph.D or Professional Degree 8 3.0% Race White 254 93.7% Black 7 2.6% Hispanic 7 2.6% Other 3 1.1% 30 em: The questionnaires were completed during a meeting scheduled for the purpose. The meetings were held at a location and time convenient to the women, usually in the evenings, and took approximately 1 1 / 2 to 2 1 / 2 hours. Meetings were held at churches, community centers, schools and at Michigan State University. Usually the room used for the completion of the questionnaires contained a table and chairs, though occasionally the women simply sat in a circle in chairs. Five to 70 women, usually from several different organizations, attended each session. Name tags and coffee were provided for the discussion session with the nurses after completion of the questionnaires. Sessions began with a brief description of the purposes of the study and instructions regarding completion of the questionnaires. See appendix A for instructions to participants. Following this, the women worked through the questionnaires individually and then participated in the group question and answer period with the nurse afterward, if they desired. Frequently the question and answer period was held in another room and women joined the discussion after they had finished with the questionnaires. Other times, it was held in the same room and did not begin until all women in the group were finished with the questionnaires. Reign I This study was a descriptive correlational study, with total on the perceived control scale as the dependent variable. The independent variables were marital status, employment status, yearly household income, educational level, religious preference, and menopausal status all measured by self-report to 31 items on the Sociodemograpic Instrument (see appendix B). Additional dependent variables were total symptom score, measured using the Menopausal Symptoms Instrument (see appendix C), type of symptom management strategies employed and mean number of strategies used, measured with the Symptom Management Instrument (see appendix D), knowledge of menopause, measured by the Menopause Information Instrument (see appendix E), and likelihood of taking estrogen replacement therapy, measured using the Judgment Cases Instrument (see appendix F). The correlation between perceived control and the independent variables (described for more fully under the instruments section) were examined using the Pearson Correlation Coefficient and one-way Analysis of Variance. Instruments Perceptions of Menopause. The items forming the Perceived Control scale were drawn from the Perceptions of Menopause Instrument (see appendix C) developed by Rothert, et al (1986). The instrument consisted of 32 statements reflecting subjective assessment of the experience or expectations of menopause. One half of the items reflected positive and half reflected negative perceptions. The response choices which formed a Likert-type scale were "strongly agree,” ”agree," ”neither agree nor disagree," ”disagree," and ”strongly disagree." Responses were coded 1 through 5, with 5 indicating a more positive perception or greater internal perceived control and 1 indicating a negative perception or less internal perceived control. The Perceptions of Menopause Instrument was constructed to have 5 scales, including Feelings, Control, Attitudes Toward Hormone 32 Table 3 Perceptions Instrument Items Item # Content 10 11 12 16 18 19 25 15 17 20 24 Menopause As Problem Scale Menopause has been / will be an unpleasant experience for me. The thought of menopause is disturbing to me. I expect to (do) experience physical trouble during menopause. I expect to (do) experience emotional trouble during the menopause. Menopause will bring / has brought many changes to my life. I have been/ will be able to experience menopause without problems. Menopause will/ did cause me to be sick a lot. Menopause probably will not/ did not have a negative effect on me. Women are more tired than usual during menopause. Menopause is associated with mood changes. .Co_nt_r_o_l_S_c_ale Menopause symptoms that I might have can be helped. There are things I can do to feel good during the menopause other than going to a health care provider. There is little that an individual can do to control the symptoms of menopause. Menopause causes problems no matter what you do. I believe that I can control menopausal symptoms. Special diets 8: foods may help control some of the symptoms of menopause. Menopause is something I just have to put up with. Hormones Help Scale Hormones are necessary for the management of menopausal symptoms. Taking hormones for menopausal symptoms can make me feel better. Positive Emctations Scale On the whole, I expect to feel better after the menopause than I did before the menopause. I welcome the menopause. 33 Therapy, Attitudes Toward Health Care Providers, and Activities of Daily Living. Ten items formed the a priori Control scale: *6, 7, 8, '9, 13, ‘14, '20, 21, ’22, and 24. The items preceded by an asterisk were reflected (1 =5, 2:4, 5=1, =2) so that a 5 on all of the items represented more internal perceived control. Each scale was scored by adding up the code (1-5) for each item in the scale. Cronbach’s alpha coefficient of internal consistency was .4531 for the a priori scale. The corrected item-total correlations ranged from .0207 to 3014. Based on item content the scale was revised. Items 7, 8, 13, and 21 were eliminated from the scale and items 15 and 17 were added. Cronbach’s alpha for the new scale was .6498. The corrected item-total correlations ranged from .1697 to .5327 and the scale variance increased from 9.59 for the a priori scale to 10.53 for the new scale. Item 14 correlated least well with the scale (I = .1697) and was eliminated to form the final scale which consisted of the following 7 items: *6, *9, 15, 17, ‘20, ‘22 and 24. Cronbach’s alpha for the final Control scale was .6580. The item content of the final scale is shown in Table 3. The Perceptions of Menopause instrument yielded four internally consistent scales in their final forms: Menopause As Problem, Control, Hormones Help, and Positive Expectations. The content of each of these scales is shown in Table 3. Only the Control scale was utilized in this study. The corrected item-total correlations for each of the 7 items in the Control scale are shown in Table 4, along with the item-scale correlations for the Control scale items with the other final Perceptions instrument scales and the inter-scale correlations. Item 17 correlated highly with the Menopause As Problem scale as well as the Control scale but was included in the Control scale based on content and because it 34 increased the reliability of the Control scale slightly by increasing the length of the scale. The minimum score possible on the scale was 7 and the maximum score possible was 35. The mean score on the scale was 2431 and the standard deviation was 3.06. The distribution of the scores on the scale is shown in Figure 1. Table 4 Interscale Correletifls for Pergpfim Ipstggment Control Men. As Prep. Horm. Help Pee. Eypee. Control 1.00 0.4838 -.1107 .0968 (p<.001) (N.S.) (N .8.) Men/ Prob. 1.00 .0956 .1046 (N .S.) (N .5.) Her. Help 1.00 .1043 (N .5.) Pos. Exp. 1.00 ................. Item-Total and Item-Scale Correlations fer Centre] Scale heme Corrected Item-Scale Correlations Item Item-Total Correlation Men/ Prob Her. Help Pos. E>_.05. An Analysis of Variance was performed to determine the relationship between employment status and perceived control over the menopause experience. There were no significant differences in perceived control over the menopause experience between women who were employed full-time, employed part-time, retired, or not employed, p > .05. 43 44 The Pearson Correlation Coefficient was computed to determine whether yearly household income correlated significantly with perceived control over the menopause experience. A 2-tailed significance test showed that the correlation between income and perceived control, was not significant at the .05 significance level. The Pearson Correlation Coefficient was computed to determine whether there was a relationship between educational level and perceived control over the menopause experience. The correlation between educational level and perceived control was found to be 1; = .1267, (p< .05, 2-tailed). The positive correlation found indicated that more highly educated women perceived greater control over the experience of menopause. The relationship was no longer significant at below the .05 level however, when the group ”Other” (N = 5) was excluded. ”Other” included "beauty school,” ”registered med. tech.," ”Associate degree in business and legal assistant,” and ”certified graphoanalyst.” The hypothesis regarding educational level and control could not be rejected at the .05 significance level. The means for each group are shown in Table 5. 45 Table 5 Education and Mean Score on Perceived Control Educational Level N Mean SD. Less than 12 Years 4 24.00 2.45 High School Graduate 61 23.69 3.04 More than 12 Years / No Degree 67 24.34 3.40 Technical/ Community College Degree 16 23.70 2.71 Bachelor’ 5 Degree 67 24.51 3.06 Master's Degree 41 24.85 2.82 Ph.D. or Professional Degree 8 24.75 2.82 Other 5 25.60 2.07 Total 269 24.31 3.06 Since no significant correlations were found for demographic variables , Null Hypothesis 1 could not be rejected. Hymthesis 2 . Null hypothesis 2 predicted that individuals who indicated a religious preference would not differ in perceived control from individuals who did not. An Analysis of Variance was performed to determine whether there was a significant relationship between religion and perceived control over the menopause experience. There was no significant difference in perceived control between those who indicated no religion, Jewish, Protestant, Catholic, or Other, 2) .05. Null hypothesis 2 was not rejected. Hmthesis 3. Null hypothesis 3 predicted that individuals categorized as menopausal according to question 13 on the sociodemographic instrument (last menstrual period) would not differ in perceived control from individuals 46 categorized as premenopausal according to the same question. Table 6 shows the means and standard deviations on the perceived control scale by last period. A higher mean on the Control scale indicated greater or more internal perceived control. A one-way Analysis of Variance was performed to determined whether menopausal women differed in perceived control over the menopause experience from premenopausal women. As Table 6 shows, the omnibus F-test for perceived control by menopausal status was statistically significant, 113, 263) = 4.9242, 2 < .05. The Scheffe multiple range test indicated that the pair ”Still have regular periods” and ”Last period 3 to 12 months ago” were significantly different at beyond the .05 level. Women whose periods were still regular scored higher (more internal) on perceived control over menopause than women whose last period was 3-12 months ago. Figure 2 shows the mean and one standard deviation for each of the four groups compared. An estimate of treatment effect size ((02) was calculated (see appendix R) and found to be .042 which indicated that Last Menstrual Period accounted for approximately 4.2% of the variance in Perceived Control. Since the omnibus F-test as well as the Scheffe multiple range test indicated that 2 groups differed significantly from each other, null hypothesis 3 was rejected. 47 Table 6 umma a" frPriv n In Mns lPri Last Menstrual Period N Mean SD. Still Regular 140 24.91 2.93 Less than 3 mos. ago 34 24.29 3.22 3 to 12 mos. ago 35 22.89 3.34 12 or more mos. ago 58 23.90 2.67 Total 267 24.35 3.04 ........... ....................................... Analysis of Variance Source D.F. Sum of Squares Mean Square F-Ratio F-Prob. a) Between Groups 3 130.5258 43.5086 4.924 .0024 .042 Within Groups 263 2323.7738 8.8356 Total 266 2454.2996 Figure 2 Mean Perceived Control 28.0 _ 27.0 _ 26.0 _ 25.0 24.0 _ 23.0 _ 22.0 _ 21.0 _ 20.0 _ 19.0 - 18.0 Mean Perceived Control By Last Period ' (24.9) 1 (24.3) 1 (22.9) ‘ (23.9) sun Regular LessThan 3 Mos. Ago :1 to 12 Mos. Ago Last Menstrual Period Mdre Than 12 Mos. Ago 49 Hmtheses 4 Q _5_. Null hypothesis 4 predicted that individuals who indicated experiencing or expecting more symptoms on the symptoms instrument would not differ in perceived control over the menopause experience from women who indicated fewer symptoms. Null hypothesis 5 predicted that women who indicated experiencing or expecting more severe symptoms on the symptoms instrument would not differ in perceived control from those who indicated less severe symptoms. The total symptom score, tabulated for each individual by summing the severity scores for all of the symptoms, reflected both severity and number of symptoms reported. Severity and number of symptoms were combined to provide a more complete picture of the women’s responses. Simply counting the number of symptoms would not have described the severity of the symptoms experienced by the woman, and dividing the total symptom severity score by number of symptoms to obtain a measure of severity per symptom was also thought to be a less useful measure of symptomatology. The Pearson Correlation Coefficient was computed to determine whether women who had a higher total symptoms expected score were lower in perceived control over the menopause experience than women who had a lower total symptoms expected score. Perceived control was found to correlate -.3530 with the total symptoms expected score, 2 < .05, 2-tailed. Correcting the correlation for unreliability in the measures (see Appendix S) increased the correlation to -.4471. This indicated that women who reported expecting fewer symptoms perceived greater (more internal) control relating to menopause than women who reported expecting more symptoms. Null hypothesis 4 was rejected. 50 The Pearson Correlation Coefficient was also computed for women who reported experiencing symptoms due to menopause (N = 207) to determine whether women who had a higher total symptoms experienced score were lower in perceived control over the menopause experience than women who had a higher total symptoms experienced score. Perceived control was found to correlate -.2353 with the total symptom score, 3 < .05, 2-tailed. The correlation corrected for unreliability (see Appendix 5) was -.2980. This indicated that women who reported experiencing fewer symptoms due to menopause perceived greater (more internal) perceived control relating to menopause than women who reported experiencing more symptoms. Null hypothesis 5 was rejected. Hmthesis 6. Null hypothesis 6 predicted that women who had a higher mean for symptom management behaviors on the symptom management instrument would not differ in perceived control over the menopause experience from women who had a lower mean. The Pearson Correlation Coefficient was computed for Control with Total Management Strategies. There was no significant relationship between total management strategies reported and perceived control (p > .05, 2-tailed). Null hypothesis 6 could not be rejected. Hmthesis 7. Null hypothesis 7 predicted that women who were higher in perceived control would not differ in the symptom management strategies used from women who were lower in perceived control. The means and standard deviations on the perceived control scale for each management strategy category are shown in Table 7. 51 Table 7 Summag Statistics for Smptom Management and Perceived Control Management War N Mean" SD. Pearson r P Medications 205 .02 .02 -.0982 N .5. Diet 204 .06 .08 .0673 NS. Vitamins 205 .04 .10 -.0440 NS. Other 205 .11 .12 .1930 .006 *Mean # of strategies per symptom per category Pearson Correlation Coefficients were computed for each management category with perceived control. Table 7 shows the correlations and 2-tailed significance level for each category. For the Medications category (see Table 8 for items), the Pearson Correlation Coefficient shown in Table 7 indicated that there was no significant difference in perceived control relating to menopause between women who utilized more versus fewer medications to manage menopausal symptoms. Table 8 shows each item listed under the symptom management category Medications and the frequency (f) with which the item was checked. The frequency indicates the total number of times the strategy was indicated. As described previously, the Management instrument asked women to indicate which strategies they used to manage their 5 most bothersome menopausal symptoms. The women wrote each of their 5 symptoms in spaces on the . instrument. Each participant could check each strategy from zero to five times. 52 If she did not use a given strategy for any of her top five most bothersome symptoms, she would not check the item at all. If she reported that she used the strategy for all 5 of her most bothersome symptoms, then she would have Table 8 Medication Strategies and Frequencies m trae Sleeping Pills Tranquilizers Blood Pressure Pills Estrogen Alone Progestin Alone Estrogen and Progestin Combined Pain Relievers Sodium Fluoride Pills Vaginal Lubricant Estrogen Creams-Vaginal Other IFIO‘VUF \0 OJ IU'INOI 01 N Total 200 checked the item 5 times. In Table 8 above, if a strategy has a frequency of ’5’,the number listed under '1’ could indicate that 5 women each used the strategy for 1 symptom each, or that one woman used the strategy for all five of her listed symptoms. The range possible for ’f’ for each strategy was therefore 0 (if not one woman used the strategy for any of her symptoms) up to NQ‘, ST) where N was the number of women (205) and EST was the total number of symptoms listed on the Management Instrument by all of the women (between 0 and 5 for each woman). For clarification of how the scale was scored see 53 appendix H. The estrogen and estrogen / progestin items were used only to screen participants, since only women who were not presently taking ERT were included in the study. The ”Other Medications" category included strategies written in by participants such as Bellergal, Norpramin, Tagamet, and P.M.S Tabs. The Pearson Correlation Coefficient shown in Table 7 indicated that there was no significant difference on perceived control between women utilizing more versus fewer Diet strategies. Table 9 shows the strategy items listed under the category Diet, and the total number of times each strategy was checked. See discussion for Table 8 for explanation of frequency information. Table 9 Diet Strategies and Frequencies amiss)! f Low Calorie ' 68 Low Fat 55 Low Salt 1 13 Low Cholesterol 42 High Calcium 46 Avoid Caffeine Products 144 Avoid Spicy Foods 17 Other 26 Total 511 The Pearson Correlation Coefficient shown in Table 7 indicated that women who utilized more versus fewer strategies listed under the Vitamins and 54 Minerals category did not differ from each other in perceived control relating to menopause. Table 10 shows the strategy items listed under the category Vitamins and Minerals, and the total number of times each strategy was checked. See discussion for Table 8 for explanation of frequency (f) information. The Pearson Correlation Coefficient shown in Table 7 was significant and indicated that women who utilized more strategies listed'under the ”Other” category perceived greater (more internal) control relating to menopause than did women who utilized fewer ”Other” strategies. The significant correlation increased to .2592 when corrected for unreliability in the measures (see Appendix S). Table 11 shows the strategy items listed under the category ”Other” and the total number of times each strategy was checked. See discussion for Table 8 for explanation of frequency (f) information. 55 Table 10 Vitamins and Minerals Strategies and Frequencies Strategy f Calcium Supplements 61 Vitamin E 45 Vitamin C 28 Vitamin D 13 Multivitamin 86 Iron 32 Other 37 Total 302 Table 1 1 ”Other” Strategies and Frequencies Strategy f Walking 237 Exercising 210 Relaxation Techniques 135 Douche 7 Skin Creams 12 Keep Diary 32 Talk With Others 175 See Health Professional 167 Other 34 Total 1009 56 Hymthesis 8. Null hypothesis 8 predicted that women who were higher in perceived control would not differ in score on overall knowledge regarding menopause from women who were lower in perceived control. A Pearson Correlation Coefficient was computed to determine whether the relationship between knowledge and perceived control was significant. The correlation between perceived control and total score on the Knowledge instrument was _i; = .2365, _(p < .05, 2-tailed). The correlation corrected for unreliability (see Appendix 5) was .3318. The null hypothesis was rejected. Women who scored higher on the Knowledge instrument perceived greater (more internal) control relating to menopause than women who scored lower. Hymthesis 9. Null hypothesis 9 predicted that mean likelihood of taking estrogen replacement therapy would not differentiate between individuals who were high in perceived control and those who were low in perceived control. The Pearson Correlation Coefficient was computed to determine whether there was a relationship between likelihood of taking estrogen replacement therapy and perceived control. Control was correlated .1271, (p < .05), with likelihood of taking hormone replacement therapy. Corrected for unreliability (see Appendix S), the correlation was .1596. Null hypothesis 9 was rejected. Women who perceived greater (more internal) control relating to menopause were more likely to take hormone therapy than women who perceived less control. Additional Analyses In order to more completely examine the relationship of the variables discussed above to perceived control, a stepwise regression analysis was 57 performed. The independent variables included in the analysis were Total Symptom Severity Score, Average Likelihood of Taking Hormones, Knowledge Score, Income, Education, Employment, Marital Status, and Last Menstrual Period. The four symptom management strategy categories were not included in the regression analysis because there was data only for women who reported experiencing symptoms. Three variables entered the regression equation at or below the .05 significance level. Total Symptom Severity Score entered the equation first B= .2548; 32 change = .0649;£ change = 17.14, p < .0001). Last Menstrual Period entered the equation second B= .3012; 18 change: .0258;£ change = 6.98, p = .0088) and Knowledge Score entered third Q: .3424; 32 change = .0265; F change = 7.36, p = .0071). To understand why only three variables out of eight entered the regression equation the intercorrelations between the variables were studied. Table 12 shows the Pearson Correlation Coefficients and significance levels for the variables included in the regression equation. 58 Table 12 Pear on rrel ' n ffi 'entM ' 0—1 0 o g a 8 E E '8 E 18 5 m m g 5 E3 {:1 2 a: Cntrol 1.00 -.2699* .1271* .2365‘ -0442 .1267* -.0879 -.0334 -.1820* Sym. 1.00 -.0752 -.0984 -.1171 -.1302* -.0055 -0314 -0359 ERT 1.00 2246* .0572* .1366‘ -.0656 .0316 -.1685‘ Know. 1.00 .1235* .2783‘ .0069 -.0248 .0304 Income 1.00 2293* -.0249 -.3502* -.0096 Educ 1.00 -.0782 .1039 -.1533‘ Empl. 1.00 -.1851‘ .1547‘ Marital 1.00 -.0617 Period 1.00 ‘p< .05 Although most of the correlations were small in magnitude, some of them were statistically significant. Education, for example was significantly correlated with each of the other variables and highly significantly correlated (p< .001) with the variable Knowledge, which had already entered the regression equation. Likelihood of Taking Hormone Therapy was also highly significantly correlated with the variable Knowledge and with the variable Last Menstrual Period, both of which were already in the regression equation. The 3 variables which entered the regression equation, Symptoms, Last Period and Knowledge accounted for 12% of the variance in Perceived Control relating to menopause. 59 The variables relating to the Symptom Management instrument were not included in the regression analysis nor in the correlation matrix because there was data for these variables only for women who indicated that they were experiencing symptoms due to menopause (N =207). Other Management Strategies (”Other") was significantly correlated with Knowledge score (1 = .25, p <.05), Education (L = .18, ,p_<.05) and Last Menstrual Period (L = -.24, p <.05). A first order partial correlation controlling for Total Symptom score increased the correlation between ”Other” and Control to _r; = .29 (p < .05). First order partial correlations controlling for Knowledge, Education, and Last Period each decreased the correlation between ”Other” and Control slightly but the correlation remained statistically significant at below the .05 level in each case. A partial correlation which simultaneously controlled for Likelihood of Taking ERT, Knowledge score, Education, Total Symptom score and Last Period increased the correlation between ”Other” and Control to _r; = .23 (N =193, p_< .05). First order partial correlations indicated that the correlation between control and education was due to the correlation between education and the variables Total Symptom Score, Likelihood of Taking Estrogen Therapy, Knowledge score and Income. In order to examine the effect of Total Symptom Score, Likelihood of Taking ERT, Knowledge score or Income on the correlation between education and control, first order partial correlation analyses were conducted. When first order partial correlations were computed which controlled for Total Symptom Score, Likelihood of Taking ERT, Knowledge score or Income the correlation between education and control 60 dropped to below .05 in each case and did not attain statistical significance. When a first order partial correlation was computed which controlled for Knowledge score the correlation between Control and Likelihood of Taking ERT no longer attained statistical significance. First order partial correlations which controlled for Education or Last Menstrual Period, resulted in correlations of L = .12 (p<.05) and _r; = .11 (p< .05), respectively. When Last Period, Knowledge score and Education were all partialled out (in that order) the correlation between control and Likelihood of Taking ERT was no longer statistically significant. Partialling out the influence of Education (N =266) on the correlation between Control and Knowledge score decreased the correlation observed only slightly (from r = .24 to _1'. =21). The correlation was still significant at below the .05 level. First order partial correlations controlling for Likelihood of Taking Estrogen (N =249), and for Income (N =249) resulted in correlations of r = .16 (p_ < .05) and L = .20 (g < .05), respectively. Partialling out Likelihood of Taking, Income and Education (in that order) resulted in a correlation of L = .16 (N =247; p_< .05). The number of cases included in the third order partial correlation analysis was 247, down from 266 when only Control, Knowledge and Education were included in the analysis. Any case for which data was missing for any one of the five variables in the third order analysis was eliminated. Partialling out the influence of the variables Likelihood of Taking ERT, Employment and Education decreased the correlation between Control and Last Menstrual period from _r; = -.18 (N = 261; p< .05) to _r; = -.14 (N = 258; p = .05). 61 A first order partial correlation controlling for Education only decreased the correlation between Control and Total Symptom Score from ,r; = -.27 (N = 267; 2 < .05) to _r; = -.26 (N=266; p< .05). mma Of the 9 null hypotheses, 6 were rejected. Null hypotheses 1 and 2 could not be rejected. The sociodemographic variables marital status, employment status, income, education and religion were not significantly correlated with perceived control relating to menopause. Sociodemographics did not predict degree of perceived control rtelating to menopause. Null hypothesis 3, which stated that there would be no relationship between control relating to menopause and menopausal status as measured by time since last menstrual period was rejected. The pair Still Regular Periods and 3-12 Months Ago were significantly different at below the .05 level of significance. Women whose periods were still regular perceived more internal control relating to menopause than did women whose last period had been 3- 12 months ago. Null hypotheses 4 and 5, that there would be no relationship between perceived control and symptoms expected (hypothesis 4) or experienced (hypothesis 5) were both rejected. Women who reported expecting or experiencing more symptoms due to menopause perceived less control relating to menopause than did those who reported fewer symptoms. Null hypothesis 6 was not rejected. There was no significant relationship between perceived control and number of symptom management strategies reported. 62 Null hypothesis 7, which stated that women who differed in the category (type) of symptom management strategies utilized would not differ in perceived control relating to menopause, was rejected. Women who utilized symptom management strategies categorized under ”Other” perceived significantly greater control relating to menopause than did women who did not. Null hypothesis 8, that perceived control would not be related to Knowledge score was rejected. Women who scored higher on the Knowledge instrument perceived more control relating to menopause than did women who scored lower. Null hypothesis 9 was also rejected. Women who indicated a greater likelihood of taking hormone therapy perceived greater control relating to menopause than did women who indicated a lower likelihood. The observed relationship between Control and Likelihood of taking ERT appeared to be primarily due to differences in Knowledge score. A partial correlation controlling for Knowledge score showed that the correlation between Control and Likelihood of Taking ERT fell to less than .10 and was no longer statistically significant at below the .05 level. Women who expected or experienced fewer symptoms due to menopause, who were still having regular menstrual periods, who scored more highly on the Knowledge instrument and who utilized more symptom management strategies categorized as ”Other" perceived more internal control relating to menopause. Chapter 4 Discussion The purpose of the study was to determine whether there were significant correlates of perceived control over the experience of menopause. Of particular interest was examining the correlates of perceived control in light of their application to designing an educational intervention for menopausal women to help them in their decision making regarding estrogen and menopause. The goal was to apply the knowledge to tailor the intervention to meet the needs of women with different levels of perceived control over their menopausal experience. Based on literature such as Duffy (1988) who found that health locus of control accounted for 16% of the variance observed in health promotion lifestyle among middle years women, the assumption was made that control was an important variable in health-related behavior and that an intervention tailored to the level of control a woman perceived to have over her experience would be more successful in meeting the needs of that woman. Self—administered questionnaires were used to gather information about women’s sociodemographic characteristics, perceptions of menopause, symptomatology, symptom management behaviors, knowledge of menopause and decision making regarding estrogen replacement therapy. These variables were then correlated with perceived control to form the basis of conclusions about menopause and perceived control. The finding that Control was not related to sociodemographics supported previous research on locus of control and demographics (Lind, 1984; Lewis, Morisky, & Flynn, 1978). The finding that religion was not related to perceived 63 64 control over the experience of menopause supported the study by Berrenberg (1987) which found that God-mediated control differed from internal and external personal control. The finding that women whose last menstrual period was 3-12 months ago scored lower (more external) on perceived control relating to menopause suggested that women who were in the perimenopause perceived less internal control relating to menopause than women who were premenopausal. This supported the findings of Littlefield 8: Adams (1987) who found that experience influenced locus of control. Since this was a cross- sectional sample it was impossible to conclude whether women perceived less internal control relating to menopause due to their menopausal status (i.e., their locus of control changed as they began to actually experience the menstrual changes related to menopause) or whether some other variable accounted for the difference in perceived control observed between perimenopausal women and premenopausal or postmenopausal women. A longitudinal study of women as they progress from premenopause through the perimenopause to postmenopause would be needed to clarify the relationship observed. It was unknown why the group ”Less Than 3 Months Ago” did not differ significantly in perceived control from the group ”Still Regular Periods” when the group ”3 to 12 Months Ago” did differ. The ”Less Than 3 Months Ago” group conceivably included women who were not yet in menopause, but had missed a period for other reasons (pregnancy, normal fluctuation in menstrual cycle, etc). It was less likely that the reported change in periods for women in the ”3 to 12 Months Ago” group was due to factors other than menopause since 64 65 more time had elapsed since the last period so women in this group were perhaps more likely to actually be perimenopausal. The finding that a higher symptom severity score was correlated negatively with internal perceived control over menopause must be interpreted keeping in mind that the direction of causation was unknown and that the data was obtained from a cross-sectional sample. It was conceivable that women experiencing more symptoms perceived less internal control relating to menopause. It was also possible that those who perceived less internal control reported more symptoms. The relationship observed may have been due to variation in a variable other than expected or experienced symptoms since the groups differed in other variables in addition to symptoms indicated. The results supported the findings of Lind (1984) however, who found that internal non-users of estrogen reported the fewest symptoms due to menopause and that external non-users of estrogen reported the most symptoms. Women who engaged in the general, health-conscious preventive strategies listed under the ”Other” category perceived greater control over their menopause than women who utilized fewer strategies listed under ”Other.” This finding coincided with Duffy (1988) who found that women who scored high on internal health locus of control and low on chance health locus of control had high scores on nutrition and exercise. The finding that women who were higher in perceived control had a higher score on overall knowledge regarding menopause supported the findings of Wallston and Wallston (1978) who reviewed five studies of health locus of control and health knowledge or inforrnation—seeking and found that across 66 studies, individuals who were more internal on locus of control had more knowledge regarding their illness or sought more knowledge than more external individuals. Again, it is important to note here that this research was correlational in nature leaving not only the direction of causality unknown, but also leaving open the possibility that the results could have been due to variation in a third factor. ' The finding that perceived control and likelihood of taking ERT were correlated indicated that women who perceived greater control over menopause were more likely to take hormone therapy, possibly because the action would relieve the symptoms of menopause and prevent osteoporosis. The review of health locus of control literature by Wallston and Wallston (1978) found that individuals who were more internal in health locus of control were more likely to engage in behaviors that facilitated physical well-being. A partial correlation controlling for Knowledge score showed that the relationship between likelihood of Taking ERT and Control was due to the correlation between Knowledge and Likelihood of Taking ERT Q = .23; p < .05). The relationship observed between control, health knowledge and health behavior suggested a path by which Control may be related to Likelihood of Taking ERT. As before however, it should be noted that the correlational nature of this study and the results of the partial correlation analysis prevented conclusions regarding the presence of a direct causal relationship between control and taking ERT. 67 Finally, the low to moderate correlations found and the fact that only three of the variables which were significantly correlated with perceived control entered the regression equation must be addressed. In previous studies of the relationship between control and health-related behaviors, control consistently emerged as a useful but weak predictor of health behavior (Lau, 1982; Strickland, 1978). The findings of this study supported this general conclusion. The relationship between control and the variables studied was small to moderate, with the strongest relationship observed between control and symptoms experienced or expected. It should be noted that several items on the perceived control scale directly related to the symptoms of menopause, which may have accounted for the strong correlation between the scale and reported symptoms. In defense of including such items however, the data indicated that women perceived menopause as defined by symptoms, not necessarily by a change in their menstrual periods. Women who had not experienced a change in their menstrual periods indicated that they were experiencing symptoms they attributed to menopause. These findings suggested that some women defined menopause according to the experience of symptoms rather than change in periods. While the relationship between last menstrual period and report of experiencing symptoms due to menopause was correlated -.34 (p_ < .05), 33% of those women whose periods were still regular reported that they were experiencing symptoms which they attributed to menopause, and 38% indicat- ed that they did not know if they were experiencing symptoms due to menopause. Only about one third of the women indicated that they were not 68 experiencing symptoms they attributed to menopause. In conclusion, several significant predictors of perceived control over the experience of menopause were identified. The magnitude of the relationships varied from L =.13 to L = -.27. The relationships identified have implications for developing an educational program for women about menopause but caution must be exercised in applying these findings due to their small magnitude and correlational nature. The finding that perceived control relating to menopause was a significant, though small aspect of the women’s experience of and response to menopause indicated that an intervention addressing women’s needs during menopause should be designed to be sensitive to the variation in perceived control among women. Women with different levels of perceived control may be experiencing or expressing different degrees of symptomatolo- gy, may present with differing levels of knowledge and may be using different strategies to manage symptoms. Most importantly they may approach their menopausal health care differently and desire grater or lesser degrees of participation in their menopausal health care decisions. It will be important to measure perceived control preintervention and postintervention but the small magnitude of the relationships observed in this study indicated that it should not be expected that perceived control will be a major influencing factor in an intervention addressing the needs of menopausal women. m The major limitations of this study included that the participants were self- selected, that the data were cross-sectional rather than longitudinal and that the correlational nature of the research prevented conclusions regarding causation. 69 Since the participants were self-selected, it was not known to what extent the results could be generalized to another sample with similar sociodemograpic characteristics, or to the population of women as a whole. Since the study was cross-sectional in nature, it could not be determined whether the results obtained were due to developmental factors. Finally since none of the variables was manipulated experimentally, the direction and nature of causality was unknown. An additional limitation was that the variables studied were all measured through self-report. No concrete behavioral data was gathered limiting the accuracy of the study to the accuracy of the self-reports. The reliability of the control scale (r = .65) was weak, which attenuated the treatment effects, contributing to the low correlations observed. Future Directions A longitudinal study examining women’s perceptions relating to menopause within women and across menopausal status would clarify the role of experience in perceptions of menopause. In addition, an experimental study which manipulated knowledge relating to menopause would illuminate the relationship between knowledge and perceived control relating to menopause. Finally, applying the findings of this study to an educational intervention for perimenopausal women in which perceived control was monitored across time would clarify whether perceived control relating to menopause was useful in understanding women's concerns regarding menopause and how they may be best addressed. As described earlier, the low correlations between control and the independent variables indicated that control was not a major influencing factor for the women in regard to their menopausal experience. The correlation 70 between control and symptoms expected or experienced indicated that perceived control may influence the experience or expression of symptoms (or expectations regarding symptoms) or that those who experience or expect more symptoms perceived less internal control relating to menopause. This finding, combined with the finding that women whose periods were still regular perceived more control relating to menopause than did women experiencing a change in their periods, may have indicated that some women might desire an intervention which provided information on issues relating to menopause as a means of returning to a sense of internal control over their menopausal experience. As pointed out earlier however, the findings of this study indicated that variables other than control influenced the women's experience of menopause and that it should not be expected that perceived control relating to menopause would be influenced in any significant way by such an intervention. An understanding of what factors influenced women’s experience of menopause must be pursued through examining factors other than control. 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Postmenopausal es- trogen use, cigarette smoking, and cardiovascular morbidity in women over 50. The New England journal of Medicine, 33, 1038-1043. Wingo, P. A., Layde, P. M., Lee, N. C., Rubin, G., 8: Ory, H. W. (1987). The risk of breast cancer in postmenopausal women who have used estrogen re- placement therapy. |oumal of the American Medical Association _257, 209-215. 78 Wolfe, B. M., 8: Huff, M. W. (1989). Effects of combined estrogen and proges- tin administration on plasma lipoprotein metabolism in postmenopausal women. lournal of Clinical Investigation, 83_, 40-45. Woods, N. F. (1982). Menopausal distress: A model for epiderniologic investigation. In A. M. Voda, M. Dinnerstein, S. R. O’ Donnell (Eds.), Changing mrepectivee en menopauee (pp. 220-238). Austin: University of Texas Press. World Health Organization. (1981). ResearQ en the menepapg (Report no. 670). Geneva: Author. APPENDICES APPENDIX A 79 APPENDIX A Instructions to Participants (Paraphrased) Hello and welcome to the estrogen replacement therapy study. The purpose of this study is to learn about what is important to women in making the decision whether or not to take estrogen replacement therapy. We are asking women who are between 45 and 55 years old, not presently taking estrogen, and who have not had a hysterectomy to participate in the study. Even if you don’t qualify to participate in the study you are welcome to look over the questionnaires if you wish, and attend the question and answer period with the nurse after the questionnaire session. It will take approximately an hour to an hour and a half to complete the questionnaires. When you are finished we will begin the question and answer period. Please complete the consent form on top of the packet. If you have any questions please feel free to ask me at any time. Sometimes our instructions aren’t as clear as they seem to us so please feel free to ask me to clarify them. If you do not wish to answer a particular question, just indicate that you saw the question but do not wish to answer it, by putting a mark or something by the question. That way we will know that you did not just accidentally miss the 80 question. You do not have to answer any questions you do not wish to, but of course the more questions you answer, the more information we get about what is important to you about this issue. Please complete the questionnaires in order. I will give additional instructions later for some of the questionnaires. If you have any questions just let me know. -Later- I’d like to clarify the instructions for the Symptoms instrument which is the questionnaire with the green and yellow pages. If you are currently experienc- ing symptoms which mbelieve are due to menopause, or have experienced symptoms in the past, answer ”yes" to question A. If you have not experienced I! symptoms which you believe are due to menopause, answer ”no. If you an- swered ”yes" to question A, complete the green pages, if you answered ”no,” complete the yellow pages. On the green or yellow pages is a list of 56 symp- toms. Not all women experience all or even most of these symptoms. This is a very comprehensive list. If you are answering the green pages, indicate only those symptoms which ygppersonally have experienced which yopbelieve are due to menopause. If you have not experienced a symptom, leave it blank If you have experienced a symptom but you believe it is due to something else, leave it blank. We are interested in mopinion. If you are completing the yellow pages, indicate only those symptoms which you expegto experience due to menopause. If you do not expect to experience a symptom leave the 81 symptom blank. If you expect to experience a symptom, but believe it will be due to something else, leave it blank. After you have checked each of the symptoms and indicated how much it does or will bother you, go back and rank the five symptoms which bother you the most, with 1 as the symptom which is most bothersome and 5 as the 5th most bothersome symptom. If you have any questions please don’t hesitate to ask. -At the End- I want to thank you all for helping us with this study. Thank you very much. If you know of anyone who would be interested in participating in the study, please have them give me a call, or I can call them. APPENDIX B 12 TI rev. h/l7/7 82 APPENDIX B s I u _____ ( “2; ° ° Pt. IO _____ (3-5 Socrodemographrc Instrument DATE ------ (6'1 I ) ERT STUDY SOCIODEMOGRAPHIC The following questions ask you to give some background Information about yourself. results. This information will help us to understand and interpret the study's The information will be kept completely confidential. Please answer each question. T3 1. How old are you? YEARS. (HRITE iN) What is your present marital status? (CHECK ONE) 1. MARRIED 2. DIVORCED 3. SINGLE (never married) 1!. HIDOHED 5. SEPARATED What is your principal employment status? (This question refers to work which ypp are paid to do.) (CHECK ONE) 1. EMPLOYED FULL-TIME 2. EMPLOYED PART-TIME 3. RETIRED 0. NOT EMPLOYED 5. OTHER (specify ) If you are employed, what Job title best describes what you do? If retired or unemployed, what Job title describes what you did? (HRITE IN). Hhat was your approximate total household Income (before taxes) during the past year? (CHECK ONE 1. Under $9,999 2. $10,000 - $15,999 3e $15,000 - $190999 . $20,000 - $24,999 e $25,000 - $299999 $30,000 ' $349999 $359000 ' 5‘99999 . $50,000 or more CD‘ICNUVJ' e e 83 -2- what was the highest grade or class you completed in school? (CHECK ONE) 1. LESS rHAH 12 YEARS 2. HIGH SCHOOL GRADUATE (INCLUDES 0.5.0.) 3. GREATER THAN 12 YEARS, our NO DEGREE TECHNICAL TRADE/COHHUNITY COLLEGE ozone: BACHELOR'S DEGREE HASTER'S atone: Ph.O./PROFESSIONAL ozone: OTHER (specify ) a‘m” eee ON 0 ”I N CH 10. 2| 8| 3| 8| 3’4 SI Please indicate your religious preference. I. 2. 3. h. 5. NONE JEWISH PROTESTANT (Baptist, Lutheran, Methodist, Presbyterian, etc.) CATHOLIC OTHER (specify what is your race? I. 2. u 0 “Wk 0 BLACK HISPANIC AMERICAN INDIAN NHITE ASIAN/PACIFIC ISLANDER OTHER (specify (CHECK ONE) How many pregnancies have you had? How many people live in your household including yourself? (CHECK ONE) NOWPWN—I 8 OR MORE ll (HRITE IN NUMBER) How are those who live with you related to you? (Check all that apply.) I. HUSBAND/SIGNIFICANT OTHER 2. 3. h. 5. PARENT(S) CHILDREN OTHER (specify NOT APPLICABLE (live alone) (CHECK ONE) 84 -3- __ 12. A) Indicate the level of stress you are experiencing at this time. 30 (PLEASE CIRCLE THE NUMBER ON THE FOLLOWING LINE). 1 2 3 h 5 6 7 8 9 NO HIGH STRESS STRESS B) Please indicate your major source of stress. (CHECK ONE) '3‘: ___ 1. WORK ___ 2. FAMILY (teenagers, caring for parents, re-marriage, etc). ___ 3. ILLNESS (family and/or self) ___ A. FINANCIAL ‘___ 5. COMBINATION OF AND (specify) ___ 6. OTHER (specify The following questions ask about your menstrual cycle. All of your answers will be kept confidential. __ 13. How many months ago was your last menstrual period? (CHECK ONE) 32 ___ i. STILL HAVE PERIODS REGULARLY ___ 2. LESS THAN 3 MONTHS AGO ____3. 3 TO 12 MONTHS AGO ___ h. 12 OR MORE MONTHS AGO __ I“. On the following line, circle the number that best shows how bad 33 you think your menstrual problems are or were. 1 2 3 h S 6 7 8 9 H0 SEVERE PROBLEMS PROBLEMS 15. Consider the following menstrual problems. Indicate whether you have experienced or are experiencing each problem by marking a check by YES or NO. Even if you experience(d) the problem occasionally, answer YES. For each problem that you mark YES, circle the number on the line that follows that best shows how severe you think the menstrual problems wus or Is for you. '__ A) CRAMPS NO TE 35 "‘ its 1 2 3 H 5 6 1 8 2 NOT EXTREMELY SEVERE SEVERE ‘81 ml N 176767 I“? 85 15. (CONTINUED) Please Indicate yes or no for each symptom. For each symptom you mark YES, circle the number which best shows how severe the symptom was or is. B) EXCESSIVE BLEEDING (HEAVY rtov, H0 FLOODING) YES I 2 3 A 5 6 ~I 0 9 H01 EXTREMELY SEVERE SEVERE C) srorrch H0 YES I 2 3 A 5 6 7 0 NOT EXTREMELY SEVERE SEVERE 0) IRREGULAR PERIODS H0 YES 1 2 3 A 5 6 7 8 9 , H01 EXTREMELY SEVERE SEVERE E) VATER RETENTION NO ' YES L 2 3 A j 6 2 8 9 NOT EXTREMELY SEVERE SEVERE r) TENSION H0 YES I 2 .3 A 5 6 7 O 2 NOT EXTREMELY SEVERE SEVERE c) HEADACHES NO YES 1: z 3 h 5 6 la 8 9 NOT EXTREMELY SEVERE SEVERE H) 01HER H0 YES 1 2 .3 h as 6 7 B Specify: NOT EXTREMELY SEVERE SEVERE 831 EQI VI "J‘t‘i‘fll claim 16. 17. (specify) 86 -5- Hhat do you do (or did you do) to relieve any discomfort you feel or felt) Just before or during your period? (Check all that apply.) I. PAIN RELIEVER (ex. Advil, aspirin, Excedrin, Tylenol) 2. REST 3. EXERCISE HEATING PADS DIET CHANGES (specify OTHER MEDICATION (specify OTHER (specify NOTHING NEEDED & a VVV “NU‘UI a a 0 Within the past five years have you ever sought medical help for problems with your menstrual periods or menopause? ___ 1. YES ___ 2. NO - go to question 18. If yes, what did the health care provider recommend? 18. Do you currently consider yourself to be experiencing menopausal symptoms? (CHECK ONE) ‘90 20. 21. : 3. H01 SURE thch of the following responses best describes your mother's menopausal experience? (CHECK ONE) 1. NO DIFFICULTIES 2. SOME OIPFICULTIES 3. SERIOUS DIFFICULTIES A. DON‘T KNOH Have you had a hysterectomy (an operation where the doctor removed all or part of your uterus)? (CHECK ONE) _1. YES _2. H0 Have one or both of your ovaries been removed? (CHECK ONE) 1. NO : 2. YES, BOTH OVARIES REMOVED 3. YES, ONE OVARY REMOVED A. NOT SURE -87 -5- 22. A) Are you currently taking estrogens (female hormones) of any kind 6? (Including birth control pills)? If In doubt, please list the name of your medication. ___ 1. YES ___ 2. NO - go to question 23 __ B. If yes, please specify the type by checking one of the following: 66 ____ estrogen pills alone ____estrogen pills and progestin pills ___ estrogen patch ____estrogen patch and progestin pills ___ birth control pills 23. Hhat would be your source of payment for any medicines you take which 67 are prescribed by a physician? (CHECK ONE) ___ Payment ls provided completely out of your pocket. '___ Payment ls provided completely by a source other than you or your family (ex, Insurance, government agency). ___ Payment Is provided partly out of your pocket and partly by another. source (ex, insurance, government agency). __ Don't know The following questions are about your health history and your health care behaviors. Again, they are to help us interpret the results of the study. All answers will be kept confidential. 2A. A) How often have you seen a health care professional (doctor, nurse) In 8'8 ‘63 the last 12 months? TIMES (HRITE IN) 70'77'72 B) What was the purpose of your vlsit(s) to a health care professional? __ ___ (CHECK ALL THAT APPLY) 73 75 7s ___ I. ROUTINE CHECK-UP (INCLUDES INTERNAL CHECK-UPS) 76 _ 2. CHRONIC PROBLEMS (Ex. BURSITIS) ____3. MENSTRUAL PROBLEMS ____h. SICKNESS (Ex. COLDS, FLU) _ S. INJURIES ___ 6. MENOPAUSAL SYMPTOMS _ 7. OTHER (SPECIFY ) __ 25. A) Have you ever had cancer? (CHECK ONE) 77 _1. YES _2.Ho -7- ‘8 26. Do you take any prescribed medications regularly? (CHECK ONE) 7 _ YES _ H0 __ 27. Do you take over-the-counter medications routinely? (CHECK ONE) 79 __ YES _ NO 3_ 28. Please check the birth control method you now use. (CHECK ONE) 0 __ 1. ORAL CONTRACEPTIVE _ 2. INTRAUTERINE DEVICE (IUD) _ 3. BARRIER METHOD (DIAPHRAGM, CREAM, CONDOM, SPONGE) _ ‘I. STERILIZATION (YOU OR YOUR PARTNER) _ 5. PERIODIC ABSTINENCE, (RHYTHM) _ 6. NO BIRTH CONTROL METHOD USED _ 7. OTHER (SPECIFY ) lsc 110:2 h/lS/87 APPENDIX C 6/15/87 89 APPENDD< C Menopausal Symptoms Instrument ‘ . Pt. ID _ _ _ fi-fi CARD __ _ (ls-5) DATE ______ (6-11) ERT STUDY Menopausal Symptoms Instrument A. Are you currently experiencing or have you experienced symptoms in the past which you believe are or were caused by menopause? ___ 1. YES If you answered [88, please answer questions on green pages, indicating only those symptoms RELATED TO MENOPAUSE which YOU are experiencing or have experienced. _2. NO If you answered ae, please answer questions on yellow pages, indicating only those symptoms RELATED TO MENOPAUSE which YOU expect to experience. __(12) If you answered £88: Listed on the next few pages are a number of symptoms which sometimes occur in women as they go through menopause. Please read the list and indicate which of these symptoms yep have experienced or are experiencing. He are interested in knowing only about those symptoms which ypg feel are caused by menopause or which you feel are directly related to menopause. For each symptom you have experienced indicate how bothersome that symptom has been for you, from "Does not bother me" (or hasn't bothered me) to "Bothers(ed) me a lot." Rank 91 If you have not experienced the symptom, leave blank. Does not bother me Bothers me a little Bothers me somewhat Bothers are a lot IL... .... Height Gain (over 10 pounds) Difficulty Sleeplpg Crying Spells Low Hork Performance Muscle Stiffness or Aches Egggetfulness Confusion Need for Npps Headaches Skin Disorders Loneliness Menstrual Crppps Dizziness or Faintness Desire to Avoid Social Activities Anxiety Baggaches Cold Sweats (perspiration) Poor Juggepent Fatigge - Tigegpess Nausea or Vgplting Restlessness Hot Flashes or Flushes CONTINUE ON NEXT PAGE _.__.-_-_-n_mh Rank 92 If you have not experienced the symptom, leave blank. Does not bother me Bothers me a little Bothers me somewhat Bothers me a lot 23. Difficulty In Concentration 2h. Painful or Tender Breasts 25. Swelling or Fluid Retention 26. Accident prone 27. lrrltability 28. Mood Swings 29. Depression _3Qe Decreased Mental Efficiency 31. _32. 33. 3h. e35. 36. 237. 38. 39. #0. hi. #2. A3. Chest Pains Decreased Motor Coordination Tensiog_(nervousness) Tingling Sensations, Numbness Palpitations - Heart Pounding Unwanted Growth of Hair Irrpggiar Periods. Bleeding Changes in Eating Habits Floodipgi(heavy:penstrual flow) Less Affectionate Expiteable Unusual Bursts of Energy, Activity Feeling of Suffocation CONTINUE ON NEXT PAGE ...--L.L....-.. -- - L- ..- - ..._.).._ _ -.— l i E If you have not experienced the symptom, . leave blank. ' Does not Bother Ime 8:)thers me a little Bothers me some-what Bothers are a lot Rank N Ah. Ringlngyjn Ears . #5. Blind Spots, Fgggy Vision I A6. Seapal Desire increased hZa_Sexual Desire Decreased #8. Lack of Eneggy #9. Lack of Confidence SO. Difficulty Making Decisions A51. Painful Intercourse ySZ. Vaginal Infections 53. Vaginal Dryness _59. Painful Urination _55. Have to Urinate More Often #56. Feeling of Crawling on Skin , , 44; Now that you have gone through the list, go back and rank the five symptoms that are most bothersome to you. Assign a ”I" beside the symptom that has bothered you the most, a "2" beside the next symptom, and so on, up to five symptoms. If you marked fewer than five symptoms, rank only the symptoms you marked. (i.e., if you marked four symptoms, you would rank them "I" to "A".) If you marked more than 5 symptoms rank only the S which bother(ed) you the most. Rank the symptoms on the left of the page in the spaces provided. _(69)_(70) (71) (72) _(73) _(7‘I)_(75) (76) .— lsc 110:5 3/2h/87 If you answered 82: Listed on the next few pages are a number of symptoms which sometimes occur In women as they experience menopause. Think about the menopausal symptoms which ypp expect to experience during that time. For each symptom which you expect to experience, Indicate how ppthersome you believe that symptom will be for you, from "will not bother me" to "will bother me a lot." 95 If you do not expect to experience the symptom, leave blank. VIII “bother me till? bother me a little VIII Bother ma MI VIII bother me a let 1. Height Cain (over 10 ppunds) .__a. Difficplty Sleeping 3. Crying Spells A. Low Uork Performance _AS. Npgcle Stiffness or Aches 6. Foggetfulness 2. Confusion 8. Need for ngs 2. Headaches 10. Skin Disorders 11. Loneliness 12. Menstrual Crgpps 13. Dizzlnggs or Fglntness 1h. Dgglre to Avoid Social Actlvltlgge 15. Anxiety 16. Backaches 12. Cold Sweats (perspiration) 18. Poor Jugggppnt 12. Fatigue - Tiredness 20. Nausea or meltlng 21. Restlessness _88. Hot Flgghes or Flushes CONTINUE ON NEXT PAGE 5 96 If you do not expect to experience the symptom, leave blank. til-II mot bother me VIII bother me a little W" yeti-er me ME VIII Bother me a lot 2}. Difficulty In Concentration 2A. Pglnful or Tender Breasts 25. Swelling or Flgld Retgptlon Mum ..- -o- b— 22. lrrltablllty 28. Mood Swings _22e_222:2!si°n m1-——L——4L—-. -. 30. Decreased Mental Efficiency 31. Decreased Motor Coordination _333 Tension (pgrvousngpg) 33. Tingling Sensations, Numbness at. Palpitations - Heart Peunding 35. Unwented Growth of Hair 36. Irregular Periods. Bleedlgg 32. Changes In Eating Habits 38. Flooding (heayy menstrual flow) . Less Affe tionate .522_§sslssatic AI. Unusual Bursts of EnergyI pgtlvlty A2. Feeling of Sggfocatlon #3. Chest Pains cares—oe— via—..- CONTINUE ON NEXT PAGE .. U r: z 97 E m i m g I I I . .‘L .2“. 2. .1“. If you do not expect to experience the symptom, 2 3 3 3 leave blank. 3: : : = S 5 5 5 Rank Ah. Ringing In Ears £5. Blind SpgtsI Fuzzy Vision ‘6. Sexual Desire Increased AZ. Sexual Desire Decreased AB. Lack of Energy , I AS. Lack of Confidence I A50. Difficulty Making Decisions 51. Painful Intergourse . 52. Vaginal Infections at E . ____ 53. Vaginal Dryness f ,. I j I ____ 5h. Painful Urination ____ 55. Have to Urinate More Often ____. 56. Feeling of Crawling on Skin : i J ' -——-I p...— —o—J—.— .. i--. g... —... . Now that you have gone through the list, go back and rank the five symptoms that you expect to be most bothersome to you. Assign a "1" beside the symptom that will bother you the most, a "2" beside the next symptom, and so on, up to five symptoms. If you marked fewer than five symptoms, rank only the symptoms you marked. (I.e., If you marked four symptoms, you would rank' them "1" to "A".) If you marked more than 5 symptoms rank only the S which you expect to be most bothersome to you. Rank the symptomslon the left of the page In the spaces provided. APPENDIX D APPENDIX D Management of Symptoms Instrument an 33 o—Lo—mu ,rIII mZOFmtrm J .c.mo yea—es Co ecuossw .enamoocoe oz“ o>u__oL cu no_Lo_eu :0 exam use :os 5. .o_mmmxu .nce=.ou o>.u ecu :— oeun__ 30> occuosxw .mnaeooeos on» Lee n_zu om 30> e. xeoGOBeu some e. to». some ecu gonzo e eu_s euou.oc. pee an.. 0:» mo ue.ce_uoa ecu ue ueeun .a.eu op 90> Leue< .~ quauuuaxmldummmummmmIUE_oou: ecu Lupe: as.» sauces» oeo oucooese acumen xamAnIuauIaAIuuAmadadquuaulaqndlumlmuMdImueo co onus» eu.L3 .oo> cu peaneoguoe Boom ozu coon use: eu.e3 weapoE>n o>.e ecu ooxemc =o> uu.eeco.uaoaa usuaoe>m .mnseooco: ecu co .. .Loeuo one co.ueo.vue anueoso—ooow .meoe.E tee c.2mu.> .uo_o ”no—LoOOumu Lace Love: at “no.5 cusps ueeu nuc.eu use» acceded use: 0: .owamoocol we menuoe>n cameos o» oo eases Bess econ. a: o—o: cu m. oL_ecco.uoe:o «.3» so enooeao oer :.wm:¢eczux >9 ommacu u¢< m>u_amn ac» :u.:: wrapax>mlmm_uzm.¢uoxu >4hzmczau =0» m¢m 4m no h2utw9¢2¢t >aahm ham 3-8 I I I HIIIH fig 313 I I I 9.3 3-3 I In. .2 .~-.. ea.n ~m\o~\m .>uL co.u-u_uoe uao ou.gx .uaaov :. u. "Axu.oonn once—av Luge: _-:.um> I «adobe cumeunu acau.ga:4 .uc.mm> n...a ot.uoa_u l:.vom ngo>o._o¢ =.om woe-osou :.unmu05¢ ecu couogunw ~<¢m>c¢m ..u.om oco_< c_unou05a ~2.¢m Am o>~u g=o> c. uu_53 100 ”Nau.uonn ammo—av Lusuc «took x04nm v.0>< n0_00 «Qua «commouv «40300;; 0:.omuou 040>< 5.2.6 $4.. _0gouno_0zu 304 u_um 304 won 304 0.50—0u 304 hm.n I . ',1 [Iv n v n ~ \\\\ m20bm£>m Am 0>_u g:0> c. 04.53 101 ”~xu.uonn ommu_nv guano :05. :_Euu_>.u—:: o c_Euu_> u c.Euu.> u c.Euu.> nucvsu_ma:m E:.u.mu mhzuzm4auam 4<¢uz.z 92¢ z.: \\\\ mZOsz>m qm 0>_u Lao> :— 04.53 102 smxmmxc mac—— um\ ua>u.uonn 0300—04 Losuo .030_nn050.m £4.00: 00m «.0333 30.: 3..» >Lo_o moo: «£0050 c.3m «£0303 n03343300h 30.40xu40g wc_n.uboxu uc_x_03 amzho w v n m \\\ szFerm 3_m 530» c. 04.33 APPENDIX E h/l7/87 103 IAPTOHQEHXFE Menopause Information Instrument Pt. ID _ _ __ “-37 DATE ______ (5-9) ERT STUDY Menopause infonmation The following questionnaire contains questions about menopause, (the change of life) a time which signifies the end of the menstrual cycle. He are interested in finding out what women know about menopause. Please answer the following questions to the best of your ability. 1. Between what ages does menopause usually begin (without hormone therapy)? (Check one) a. 35 TO “A YEARS. b. 55 TO Sh YEARS. c. 55 TO 6“ YEARS. Ovulation frequently occurs for how many years after a women stops menstruating? (Check one) a. 0 YEARS (Not at all). h. 1 YEAR. c. 2 YEARS. d. 3 YEARS. e. A YEARS. What can be said about birth control after menstruation stops? (Check one) I. BIRTH CONTROL SHOULD BE USED FOR 1 YEAR. b. BIRTH CONTROL SHOULD BE USED UP TO 5 YEARS. c. BIRTH CONTROL SHOULD BE USED AS LONG AS SEXUALLY ACTIVE. d. BIRTH CONTROL IS NOT NECESSARY. What causes the symptoms of menopause? (Check one) I. THE PITUITARY GLAND STOPS FUNCTIONING. b. THE UTERUS HILL NOT ALLOH ECG INPLANTATION. c. THE FALLOPIAN TUBE BECOMES BLOCKED. d. THE OVARIES PRODUCE LESS ESTROGEN. 0. ALL OF THE ABOVE slaw-Al alslal 104 -2- 5. Menopause increases the risk for which of the following? (Check all that apply.) a. b. c. d. e. f. LIVER DISEASE. HEART DISEASE. KIDNEY DISEASE. LUNG DISEASE. OSTEOPOROSIS (BRITTLE BONE DISEASE). ALL OF THE ABOVE NONE OF THE ABOVE 6. Hhat physical changes can occur In the vagina due to>menopause? (Check one.) a. b. c. d. IT BECOMES DRYER AND LESS ELASTIC. IT BECOMES SHORTER AND MORE NARROH. IT BECOMES THIN AND EASILY INJURED. ALL OF THE ABOVE. 7. For how many years do menopausal symptoms without estrogen treatment a. b. c. d. usually last? (Check the best response.) I TO 2 YEARS. 3 TO 5 YEARS. 6 TO 10 YEARS. MORE THAN 10 YEARS. 8. By the end of menopause, which of the following occur? (Check all that apply.) a. b. c. d. THE OVARIES DECREASE FUNCTIONING. MENSTRUAL BLEEDING HILL HAVE STOPPED. OSTEOPOROSIS (BRITTLE BONES) OCCURS MORE. ALL OF THE ABOVE. 9. Osteoporosis (brittle bones) may be treated by: (Check all that .) a. b. c. d. |||| - 'U U - ‘< ESTROGEN PILLS. SUFFICIENT CALCIUM INTAKE. MODERATE PHYSICAL ACTIVITY. ALL OF THE ABOVE. Please answer the following questions with "true" or "false". (Circle True or False for each question) 10. Hormone therapy (estrogen) after menopause increases the risk of osteoporosis. TRUE FALSE ll. 12. 13. 1“. 15. l6. 17. 18. 105 -3- Hormonal therapy can be used to help relieve the symptoms of menopause. TRUE FALSE Estrogen therapy increases the risk of cancer of the uterus. TRUE FALSE Bleeding or spotting a year after a woman completely stops menstruating (menopausal women) should be reported to your physician. TRUE FALSE Symptoms most often reported during menopause are hot flashes and night sweats. TRUE FALSE Once a woman is through menopause she no longer has to be concerned with breast cancer or other female cancers. TRUE FALSE By the time of the last menstrual period, women can generally not become pregnant. TRUE FALSE As long as a woman is ovulating she can still become pregnant. TRUE FALSE Ovulation may occur without menstrual bleeding occurring. TRUE FALSE Isc 110:1 106 -q- 19. To help reduce the uncomfortable feelings associated with hot flashes, a person can...(Check one) a. eat a balanced diet d. exercise daily b. take extra vitamins e. estrogen replacement therapy c. wear layered clothing f. all of the above 20. Vaginal dryness caused by menopause may lead to...(Check one) a. painful intercourse b. increased chance of infection 0. itching d. all of the above 21. Vaginal dryness can best be relieved by...(Check one) a. using a water soluble lubricant b. using a vaseline lubricant c. douching d. estrogen replacement therapy h/lS/87 APPENDIX F Site __‘__ 44(145) Pt. iO_____ (3-5) 107 Date ______ (8-13) APPENDR F lI/28/87 Judgment Cases Instrument INFORMATION SHEET He are going to give you some written situations (cases) and ask you to imagine yourself in that situation. You will be asked to read each case and indicate how likely you would be in that situation to take hormone therapy. There are two sets of 16 cases each, and it will probably take you about 30 minutes to complete all of the cases. The purpose of asking you to tell us what you would do in these situations is to find out what information is important to women in making these decisions. He want to make sure that you have all the information you need to make those decisions. Therefore, we have written down some of the facts that we think would be helpful to you. There are at least three important things to think about when you consider whether to take estrogen therapy. These three factors are menopausal symptoms, risk of fractures due to osteoporosis, and risk of endometrial cancer. Information about each of these factors is given below. Also, there is a paragraph about estrogen therapy and whether it would be expected to help or make worse each of the three factors. MENOPAUSAL SYMPTOMS-Somewhere in middle age, usually around fifty years of age, women stop having monthly menstrual periods and are said to be going through menopause or, "the change of life". One of the most common problems that women mention related to menopause is hot flashes or the feeling of warmth in the upper body. These hot flashes are usually mild, and even if untreated, usually subside in a period of a few months or years. Some women may have severe hot flashes accompanied by perspiration which cause them to lose sleep or make it difficult or embarrassing to carry out their daily activities. RISK OF FRACTURES DUE TO OSTEOPOROSIS-You may have heard people talk about having broken bones or fractures because they have brittle bones. Usually, they are referring to osteoporosis, where the bones become weaker after menopause. Thin, white women who smoke and do not exercise have the highest risk of fractures due to osteoporosis, and black women, heavier women, and those who exercise regularly have a lower risk. Assuming the usual life-span of 85 years, for women presently 60-65 years old it is estimated that SO out of 1,000 will have a fracture of the hip, spine, wrist or pelvis due to osteoporosis each year. For many younger people fractures may not be perceived as very serious, but in the older populations complications can occur. One third of women over age 65 will have vertebral fractures. By extreme old ago, one of every three women will have had a hip fracture. This catastrophic type of fracture is fatal in l2 to 20 percent of cases and it leads to long-term nursing home care for half of those who survive. 108 RISK OF ENOOMETRIAL CANCER-Endometrial cancer is cancer of the uterus or womb. In women not takingiestro en, approximately 1 in l000 can be expected to develop endometrial cancer each year. in most cases, if cancer develops, it is detected early because it causes vaginal bleeding. it can be treated with a hysterectomy (surgical removal of the uterus) and removal of the ovaries with a 902 cure rate. However, if the cancer is advanced, it can cause significant pain and not only require a hysterectomy, but also some form of follow up radiation (X-Ray) therapy and perhaps anticancer drugs (chemotherapy). ESTROGEN REPLACEMENT THERAPY-You may have heard about other hormone treatments for menopause, but this information is about estrogen alone. If you were taking estrogen therapy, one plan is that you would take a pill once a day for 25 days, then not take any pills for 5 days each month. There are other plans and your doctor would prescribe the best one for you. The pills cost approximately $5.50 per month. The physician would want you to come in for an annual physical. Possible side effects other than those mentioned include weight gain, nausea and vomiting, breast tenderness or enlargement. ormone therapy with estrogen reduces or eliminates hot flashes, decreases the chance of fracture due to osteoporosis, but increases the chances of endometrial cancer. Estrogen therapy does not bring back monthly bleeding. Fractures due to osteoporosis are much more common than endometrial cancer. in numbers, for women who are not takin estro cn and who are presently 60-65 years old (assuming the usual life span of BS years) the occurance of fractures and endometrial cancer is as follows. 50 out of every 1,000 women can be expected to develop fractures of the hip, spine, wrist or pelvis each year, and 1 out of every 1,000 women can be expected to develop endometrial cancer each year. Most of the deaths due to complications of fractures and most of the deaths due to endometrial cancer occur after age 75. In women takin estro en who are presently 60-65 years old (assuming the usual life span of BS years) 25 out of every 1,000 women can be expected to develop fractures of the hip, spine, wrist or pelvis each year, and 6 out of every l,OOO women can be expected to develop endometrial cancer each year. The estrogen increases the risk of cancer from I per 1,000 to 6 per 1,000, but cuts the osteoporosis fracture risk in half, from 50 per 1,000 to 25 per 1,000. Not only is the occurrence of osteoporosis fracture greater than cancer, but the death rate is also higher. Overall, approximately 3,000 women die of endometrial cancer each year and 50,000 die due to complications associated with fractures in the 0.5. each year. Again, these deaths occur mostly after age 75. Therefore, the woman in menopause is faced with a difficult decision: to take the hormone therapy and run a higher risk of developing uterine cancer, or not take it and run a higher risk of developing bone fractures. The following graphs may be helpful in better understanding this information. 109 1,000-I WofVomenPeripOOVho 1,0001 NunberofVomenPerLOOOHho / / Experience fractures I / 0et Endometrial Cancer Each Year Each Year 50 .. (5°) 50 _. I Home Not Tm Hormones I 40 _ 4O _ Yemen Not Takhg Hormones 7" Vernon Taking Estrogen so - 3° - Yemen Takhg Estrogen (25) 20 ._ y 20 .. 10 4 '0 ‘ (6) 0 - /A 0 4A Ezzza No Hormone Therapy Hith Estrogen Therapy No Hormone Therapy Vith Estrogen Therapy I Number ofHomethoDieEach Year I I Due to fractures and mum We so - (50 000) ,000 I Death from Complications ‘0 00° of fractures “11] Death from Endometrial 30,000- Cancer 20,”... mm" (3 000) 0 _ IITIIIIIIII Complications of Fractu'es Endometrial Cancer *Host of the deaths related to both complications of fracttres mdendcmetrtaloanceroccwafterage‘ls. 110 DEFINITIONS h/l7/87 Now we want you to imagine yourself in a number of real situations and think about how likely you would be to take estrogen therapy in each of those situations. You will be given three kinds of information about each situation. This information will include how bad the menopausal symptoms are, chances of getting endometrial cancer, and chances of developing osteoporosis. He ask you to think about what it would be like if you were in this situation. Listed below are the definitions of several terms you will need to know. MENOPAUSAL SYMPTOMS-This refers to how bad your hot flashes are and whether they are interfering with your sleep, social activities, work and daily activities. He have defined two levels of menopausal symptoms. High level means that you have very bad hot flashes which interfere with your sleep, daily activities, and social life. Standard level means that you have a few hot flashes which really don't bother you or interrupt your daily life. RISK OF FRACTURE DUE TO OSTEOPOROSIS-This refers to how likely it is that you will develop fractures due to osteoporosis. Hith osteoporosis bones become more porous and brittle and may break more easily. He have defined two levels of risk. ' High level means that you have a greater than average chance of developing fractures of the hip, spine, wrist or pelvis due to osteoporosis. On the average, about 50 women out of 1,000 have such a fracture but the high level defines you as having a greater than 50 out of 1,000 chances of having a fracture. Standard level means that you have an average chance of having a fracture due to osteoporosis. Thus, your chances are about 50 out of 1,000 per year. RISK OF ENDOMETRIAL CANCER-This is a description of how likely it is that you will develop endometrial cancer. Endometrial cancer is cancer of the lining of the uterus, or womb. He have defined two levels: High level means that you have a greater than average chance of developing endometrial cancer. On the average, about one woman in 1,000 develops endometrial cancer each year but the high level defines you as having a greater than i in l,OOO chance of having endometrial cancer. Standard level means that you have an average chance of developing endometrial cancer. Therefore, your chances of developing endometrial cancer are about i in 1,000 per year. As you read the cases please try to consider each one individually. The cases may seem very similar, but it is important to consider each one. Do not 'worry about how you answered earlier cases, just consider each one as you read it. The number of women who experience each problem on the average (that is, the average risk) will be written in parentheses to help you. h/20/87 111 DIRECTIONS PLEASE REMOVE THIS PAGE FROM THE BOOKLET AND REFER TO THE DIRECTIONS AND SCALE AS YOU READ AND MAKE JUDGMENTS ON EACH CASE. Each of the following situations will ask you to Imagine that you are experiencing hot flashes at a standard (average) or high level, that you are at a greater or standard (average) risk than most women for developing osteoporosis and endometrial cancer, and ask you how likely you would be in that situation to take hormone pills. Please read each case and decide how likely you would be to take hormone pills in the situation described. Make your decision using the following scale: I. VERY CERTAIN THAT YOU HOULD NOT TAKE HORMONE THERAPY 2. PROBABLY HOULD NOT TAKE HORMONE THERAPY 3. MAY OR MAY NOT TAKE HORMONE THERAPY h. PROBABLY HOULD TAKE HORMONE THERAPY 5. VERY CERTAIN THAT YOU HOULD TAKE HORMONE THERAPY For each case, write down the number from this scale that represents your decision as to how likely you would be to take hormone therapy In the situation described. Continue until all cases are completed. The first 2 cases are practice cases followed by l6 cases. 112 PRACTICE CASE 1 You have frequent and severe hot flashes which interfere with your sleep and make it difficult to carry out your daily activities. You have been told by your physician that you have an average chance (50 out of l,OOO women) of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis. Your chances of developing endometrigl cancer are greater than most women (greater than i in a l,OOO) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY HOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSHER: aesassoeaaeeaaaoaeeetattoos*aeeeeeeoeeaeasoeeeaoeesaaaeaeeaeaaeeseeeeaeassess Using the descriptions given, consider the level of hot flashes described, your risk for fractures due to osteoporosis and risk for endometrial cancer as described in the case. If you need to look back at the more detailed descriptions of each, do so. Hrite down your decision as to how likely you would be to take hormone therapy in each situation. Hrite your decision on the line following the word ANSHER. Refer to the "Directions" and choose the number on the 5 point scale that most closely represents your judgment. For example, if you feel you probably would not take hormone therapy in this situation, put a 2 on the line as your answer. aeeeeaeeeateoattestseeaeeseeaeaaeetetoterseatoesaseeaseeeeeoeeoaeaoeaaeeaseee PRACTICE CASE 2 You sometimes have mild hot flashes but they do not keep you from sleeping or bother you very much during the day. Hhiie 50 out of 1,000 women on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that your chances are higher than average. Your chances of developing endometrial cancer are greater than most women (greater than i in'a 1,000) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY HOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSHER: 113 CASE 1 You sometimes have mild hot flashes but they do not keep you from sleeping or bother you very much during the day. You have been told by your physician that you have an average chance (50 out of i,000 women) of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis. Your chances of developing endometrial cancer are greater than most women (greater than i in a l,OOO) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: CASE 2 You have occasional mild hot flashes which do not Interfere with your sleep or other daily activities. Hhiie 50 women out of 1,000 on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that your chances are higher than that average. Your chances of developing endometrial cancer are about avera e, that is about 1 out of 1,000 women according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: CASE 3 You have many severe hot flashes that keep you from sleeping well and interfere with what you normally do during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are about average (50 chances out of l,000) according to your physician. Your chances of developing endometrial cancer are greater than most women (greater than i in a l,000) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: 114 CASE A You have had some mild hot flashes but are able to sleep O.K. and they have not kept you from doing your usual daily activities. You have been told by your physician that you have a greater than gverggg chance of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis (odds greater than 50 out of 1,000). You have been told by your physician that you have a greater than averagg (that is, greater than i in a 1,000) chance of developing endometrial cancer meaning you are at higher risk than most women. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: CASE 5 You have occasional mild hot flashes which do not interfere with your sleep or other daily activities. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are about average (50 chances out of 1,000) according to your physician. You know that I out of I,OOO women on the average will develop endometrial cancer, and your physician tells you that your chances are about average. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSHER: CASE 6 You have manygsevere hot flashes which cause you to lose sleep and keep you from doing your usual daily activities. - You have been told by your physician that you have a greater than avergge chance of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis (odds greater than 50 out of 1,000). Your physician tells you that you have an average chance, (i out of 1,000 women) of developing endometrial cancer. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? . ANSHER: 115 CASE 7 You have frequent and severe hot flashes which interfere with your sleep and make it difficult to carry out your daily activities. About 50 women out of 1,000 on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that you have the an average chance of developing the problem. You know that l out of 1,000 women on the average will develop endometrial cancer, and your physician tells you that your chances are about average. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSHER: CASE 8 You have many severe hot flashes that keep you from sleeping well and interfere with what you normally do during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are greater than the average (greater than 50 out of 1,000 women) according to your physician. Hhiie I in 1,000 women on the average will develop endometrial cancer, you have been told by your physician that your chances are higher than averag . QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSHER: CASE 9 You have had some mild hot flashes but are able to sleep O.K. and they have not kept you from doing your usual daily activities. You have been told by your physician that you have a greater thanAgverage chance of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis (odds greater than 50 out of 1,000). You have been told by your physician that you have a greater than average (that is, greater than i in a 1,000) chance of developing endometrial cancer meaning you are at higher risk than most women. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: 116 CASE lO You have occasional mild hot flashes which do not interfere with your sleep or other daily activities. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are about average (50 chances out of 1,000) according to your physician. You know that 1 out of 1,000 women on the average will develop endometrial cancer, and your physician tells you that your chances are about average. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: CASE 11 You have many severe hot flashes tfat keep you from sleeping well and interfere with what you normally do during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are gieater than the averggg (greater than 50 out of l,000 women) according to your physician. Hhiie l in 1,000 women on the average will develop endometrial cancer, you have been told by your physician that your chances are higher than avergg_. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: CASE l2 You have frequent and severe hot flashes which interfere with your sleep and make it difficult to carry out your daily activities. About 50 women out of i,OOO on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that you have an average chance of developing the problem. You know that 1 out of l,OOO women on the average will develop endometrial cancer, and your physician tells you that your chances are about averag . QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: 117 CASE 13 You have many severe hot flashes which cause you to lose sleep and keep you from doing your usual daily activities. You have been told by your physician that you have a greater than average chance of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis (odds greater than 50 out of 1,000). Your physician tells you that you have an average chance (1 out of l,000 women) of developing endometrial cancer. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: CASE 1“ You have many severe hot flashes that keep you from sleeping well and interfere with what you normally do during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are about average (50 chances out of 1,000) according to your physician. ‘ Your chances of developing endometrial cancer are greater than most women (greater than i in a 1,000) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSHER: CASE l5 You have occasiongi mild hot flashes which do not Interfere with your sleep or other daily activities. Hhiie 50 out of 1,000 women on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that your chances are higher than that average. Your chances of developing endometrial cancer are about average, that is about 1 out of 1,000 women according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSHER: 118 CASE l6 You sometimes have mild hot flashes but they do not keep you from sleeping or bother you very much during the day. You have been told by your physician that you have an average chance (50 out of l,000 women) of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis. Your chances of developing endometrial cancer are greater than most women (greater than I in a i ,000) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN HORMONE THERAPY? ANSVER: 119 lI/6/87 DIRECTIONS-SET 2 You will find the next set of cases very similar to the first set you just completed. The one difference is the hormone treatment. You have been thinking about whether to take estrogen, an example of which was one pill for 25 days followed by no pill for 5 days. The estrogen decreases the risk of osteoporosis, relieves hot flashes, but increases the chance of endometrial cancer. There is another treatment program we would like you to think about now. This hormone treatment would be estrogen and progestin. One plan would be on a 30 day cycle, you would take on estrogen pill for 15 days, then take an estrogen pill and progestin pill for the next 10 days, then no pills for five days. The cost would be approximately $l2.50 per month. There are other plans and your doctor would prescribe the best one for you. As the chart below shows, adding the progestin takes away the problem of increasing the risk of endomentriai cancer, that is, if you take this treatment program the risk of endometrial cancer is no greater thgn if you did not take the es t rogen e Taking this treatment program does have one other side effect. You will again start or continue to have vaginal bleeding or monthly periods. Thus, estrogen with progestin will relieve hot flashes, reduce osteoporosis, have no increase in risk of cancer, but will cause monthly periods. Please turn the page and answer this set of cases by indicating how likely you would be in each case to take the combined estrogenlprogestin hormone therapy. Use the page you pulled out for the first set to refer to for the response scale. I pm -| Number of Vomen Per I ,000 th / Get Endometrial Cancer / Each Year 50... 1 Women Not Taking Hormones 40... [:J‘MunuanfingEshmguiAmdPnunsWn 30___ , Homer) Taking Estrogen Only 20... '° —' . (6) o (l) (I) m #— NeikrnwneThwupy ‘VHhEsbegudanpan ‘fflhfigbmgflgom~ 0/6/87 120 CASE 1 You sometimes have mild hot flashes but they do not keep you from sleeping or bother you very much during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are ggeater than the averagg (greater than 50 out of 1,000 women) according to your physician. Your physician tells you that you have an average chance, (i out of l,000 women) of developing endometrial cancer. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSHER: CASE 2 You have had some mild hot flashes but are able to sleep O.K. and they have not kept you from doing your usual daily activities. About 50 women out of 1,000 on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, and you have been told by your physician that you have an average chance of developing the problem. You have been told by your physician that you have a greater than averggg (that is, greater than i in 1,000) chance of developing endometrial cancer meaning you are at higher risk than most women. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSHER: CASE 3 You have many severe hot flashes that keep you from sleeping well and interfere with what you normally do during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are about average (50 chances out of l,000) according to your physician. Your chances of developing endometrial canceF are about the same as avera e, that is I out of l,000 women according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN /PROGESTIN HORMONE THERAPY? ANSVER: 121 CASE A You have many severe hot flashes which cause you to lose sleep and keep you from doing your usual daily activities. You have been told by your physician that you have a greater than average chance of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis (odds greater than 50 out of l,000). Your chances of developing endometrial cancer are greater thgn most women (greater than i in a 1,000) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSVER: CASE 5 You have occasional mild hot flashes which do not interfere with your sleep or other daily activities. Hhiie 50 out of l,000 women on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that your chances are higher than that average. Hhiie i in 1,000 women on the average will develop endometrial cancer, you have been told by your physician that your chances are higher than averag . QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSHER: CASE 6 You sometimes have mild hot flashes but they do not keep you from sleeping or bother you very much during the day. You have been told by your physician that you have an average chance (50 out of 1,000 women) of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis. Your chances of developing endometrial cancer are about avera e, that is I out of 1,000 women according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSVER: 122 CASE 7 You have frequent and severe hot flashes which interfere with your sleep and make it difficult to carry out your daily activities. Hhiie 50 out of 1,000 women on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that your chances are higher thgh that average. You know that 1 out of 1,000 women on the average will develop endometrial cancer, and your physician tells you that you chances are about average. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY?" ANSVER: CASE 8 You have many severe hot flashes which cause you to lose sleep and keep you from doing your usual daily activities. You have been told by your physician that you have an average chance (50 out of 1,000 women) of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis. You have been told by your physician that you have a greater than average (that is, greater than i in 1,000) chance of developing endometrial cancer, meaning you are at higher risk than most women. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSHER: CASE 9 You have many severe hot flashes which cause you to lose sleep and keep you from doing your usual daily activities. You have been told by your physician that you have a greater than average chance of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis (odds greater than 50 out of 1,000). Your chances of developing endometrial cancer are greater than most women (greater than i in a l,000) according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSVER: 123 CASE 10 You have occasional mild hot flashes which do not interfere with your sleep or other daily activities. Hhiie 50 out of 1,000 women on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that your chances are higher than that average. Hhiie I in 1,000 women on the average will develop endometrial cancer, you have been told by your physician that your chances are higher than average. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSVER: CASE 11 You have many severe hot flashes which cause you to lose sleep and keep you from doing your usual daily activities. You have been told by your physician that you have an average chance (50 out of 1,000 women) of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis. You have been told by your physician that you have a greater than average (that is, greater than I in 1,000) chance of developing endometrial cancer, meaning you are at higher risk than most women. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSHER: CASE 12 You have frequent and severe hot flashes which interfere with your sleep and make it difficult to carry out your daily activities. Hhiie 50 out of l,000 women on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, you have been told by your physician that your chances are higher thgh that average. You know that I out of l,000 women on the average will develop endometrial cancer, and your physician tells you that you chances are about average. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY?" ANSVER: 124 CASE 13 You sometimes have mild hot flashes but they do not keep you from sleeping or bother you very much during the day. You have been told by your physician that you have an average chance (50 out of 1,000 women) of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis. Your chances of developing endometrial cancer are about aver e, that is I out of 1,000 women, according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSHER: CASE IA You have many severe hot flashes that keep you from sleeping well and interfere with what you normally do during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are about average (50 chances out of 1,000) according to your physician. Your chances of developing endometrial cancer are about the some as avera e, that is 1 out of l,000 women, according to your physician. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSVER: CASE 15 You have had some mild hot flashes but are able to sleep O.K. and they have not kept you from doing your usual daily activities. About 50 women out of 1,000 on the average will develop a fracture of the hip, spine, wrist or pelvis due to osteoporosis, and you have been told by your physician that you have an average chance of developing the problem. You have been told by your physician that you have a greater than average (that is, greater than I in 1,000) chance of developing endometrial cancer meaning you are at higher risk than most women. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSVER: 125 CASE l6 You sometimes have mild hot flashes but they do not keep you from sleeping or bother you very much during the day. Your chances of developing a fracture of the hip, spine, wrist or pelvis due to osteoporosis are greater than the average (greater than 50 out of 1,000 women) according to your physician. Your physician tells you that you have an average chance, (1 out of 1,000 women) of developing endometrial cancer. QUESTION: IN THIS SITUATION, HOV LIKELY VOULD YOU BE TO TAKE ESTROGEN/PROGESTIN HORMONE THERAPY? ANSVER: 1. Assuming equal benefits would result, how would you rate your preference for each of the following ways of taking estrogen and progestin? Much the preferred method Preferred over some other methods Probably not as preferred as other methods I; 3 2 l Definitely not a preferred method 1. Injections taken every month 2. Skin implants that need to be changed periodically 3. Pills A. Patch 2. Besides risk of osteoporosis and endometrial cancer, relief of hot flashes, and resumption of monthly bleeding, are there any other factrors or pieces of information that are important to you in deciding whether to take hormone therapy for menopausal symptoms? YES NO If YES, please explain. 126 3. Please indicate on the scale provided how important each factor was to you as you responded to the cases. Hot Flashes I 2 3 A 5 6 Not Important Extremely At All important Risk of Endometrial Cancer i 2 3 II 5 ' 6 Not Important Extremely At All important Risk of Osteoporosis I 2 3 A S 6 Not Important Extremely At All Important Resumption of Monthly Bleeding I 2 3 A S 6 Not Important ' Extremely At All Important - Thank you for your help. APPENDD( G rev. A/l7/37 127 Pt. ID ___ (I-3) oars Ih-si ALPPTHVEMDIC; ””” Perceptions of Menopause lnstmment ERT STUDY Perceptions of Menopause Some of you will have not experienced menopause yet, and some of you are experiencing menopause now. He are interested in finding out what your perceptions are about menopause regardless of whether or not you are experiencing menopause. In the questions that follow, please circle the response that most represents how you feel about each statement. 1. Menopause has been/will be an unpleasant experience for me. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE The thought of menopause is disturbing to me. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE My body may change during the menopause, but I will not change personally. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE On the whole, I expect to feel better after the menopause than I did before the menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE I welcome the menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Menopausal symptoms that I might have can be helped. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE '00 ll. 12. 13. IA. 128 -2- Homen should be under a health provider's care during menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Hormones are necessary for the management of menopausal symptoms. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE There are things I can do to feel good during the menopause other than going to a health care provider. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE I expect to (do) experience physical trouble during the menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE I expect to (do) experience emotional trouble during the menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Menopause will bring/has brought many changes to my life. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE . DISAGREE I am confused about all of the controversy over hormone treatment and menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE DeSpite what health care providers say, I believe I should make the decisions about management of my menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE 15. i6. 17. 18. 19. 20. 21. 22. 129 -3- There Is little that an individual can do to control the symptoms of menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE I have been/will be able to experience menopause without problems. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Menopause causes problems no matter what you do. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Menopause will/did cause me to be sick a lot. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Menopause probably will not/did not have a negative effect on me. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE I believe that I can control menopausal symptoms. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Taking hormones for menopausal symptoms can make me feel better. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Special diets : foods may help control some of the symptoms of menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE 23. 2h. 25. 26. 27. 28. 130 4,- Homen are more tired than usual during menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Menopause is something I Just have to put up with. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Menopause is associated with mood changes. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Most women make too much of menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE Health care providers don't really understand the problems women experience with menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE There is a difference between male and female health care providers in how they understand the problems that women experience with menopause. STRONGLY NEITHER AGREE STRONGLY AGREE AGREE NOR DISAGREE DISAGREE DISAGREE 131 -5- Hhen I experience menopause I feel that...(PLEASE CHECK ONLY ONE ANSHER FOR EACH QUESTION) 29. A) My sex life will be/is more satisfying. B) My sex life will bells relatively the same. C) My sex life will be/is less satisfying. 30. A) My sleep patterns will get/are better. B) My sleep patterns will remain/are relatively the same. C) My sleep patterns will get/are worse. __ A) Participating in social activities will be/is much more enjoyable. AD 1.. B) Participating in social activities will be/is no more or less enjoyable. C) Participating in social activities will be/is much less enjoyable. 32. __ A) It will be/is much easier for me to do the things that i normally AT do during the day. B) There will be/is little change in how I do the things that I normally do during the day. C) It will be/is more difficult for me to do the things that I normally do during the day. lsc IIO:A 3/26/87 APPENDD( H 132 APPENDIX H Equations for Management Scales 4.0.84 Emsmmoaoa wooed n M N a. + game N... u nemvosmo moo. gauges" 093881. 4.9. £30205 .4 on: u c on r o u Doom Son :me 05:09. 4.“ H .I. 008 new $385 .5 :4. n 88: :0. on E032: mpg—"350 .I. am We u 90$— 50. 0». $568.30 580 - 00853 v.05 35.80 $35835 o: $56880 Sages" .9. $58 ~85 H 8 m4 133 nus 30908505 moan wooed n M Na. Iv game on... n 5000500 ..2. 5550505 03.089. .. mop. 05305 .4 a2. 0.: X... 5 0085—9. .5. on... u c on r o n 6000 so» :00 0.5884 4." a n 6000 :00 0538‘ .3 35 u 85— :0. 0.. 553052: 0.0.3.500 5 509003050 omnomonv. u 3 m... u 85— :0. 0m 050850 :08“. - 065500 3.05 Baron 0253050 0: 053050 505505 Ame 5300 5.05 w 8 m4 134 F.” OR» momma @256 n M Na. + Emma N: u mam—x58 3.. 55mmn5a=n 5588‘ r m5. 3.5305 ._ m5. m: N: 5 awwnmog d. on: u o 5. r o u anm 52 can mfimnnmw .5 H u doom :2" @585. .5 39 u 85. 5.. o». 55mma52: $5888 5 En» gamma—Q u m ma u 88.— 50. o». m<5¢~o5m =33 - 3552— ».35 5589 $5685 a: m5©85m 55552: .mq. <58 .35 H 8 m. 135 _n< <fim55\§52.5 mow—m macaw u m Na. + 75mg. X... n 85.58 ..2. 5955855" 9.585. r ..9. @5585 ._ ..5. m: x... 5 885$. .<. om: u o 5. r o u 608 so» :8 $589. .5 a u Dog :8 2588‘ .5 Zr. n 85— 5a. 0.. 55558585" mgnmflnm 5 5555\5585 8853. u q mg. n 85— 5a. 0.. $55.65,; :53 - 3553 ~35 5589 $5585 a: m5vno5m 55555» Amq <58 ~35 H 8 m. 136 We .095... mom—Hm macaw" Mum... IHHSHZ >25 ’32ng mgvgzmza H... H I' 65855 9558558 1 HH 5 u u IV 535:: m «up A2555 0 5555 D 2553555 H35 . 4 4 A 058 5888 585.. n 0585558” pr u H“ XxHAW u H“ XmH u H“ me u H“ me u H“ 59.»: 058. Xu 0 m4u£§develop»educational materials for women, tijrovide the information they need aboutimenopauee and to‘help themlmake informed decisions about estrogen therapy and other health care issues. If participants completed the formnrequeating a copy of the results