Decision making about low dose tamoxifen in HRT users: Psychological and clinical factors.

A28

Purpose: To determine the social demographic, health-related and psychological factors that influence decision making about a chemoprevention trial of low dose tamoxifen in women undergoing or considering hormone replacement therapy (HRT) in an attempt to retain the benefits while reducing the risks of either agent. Subjects and Methods: The study involves the assessment of 457 women eligible to take tamoxifen 5 mg/day to reduce breast cancer risk associated with HRT use who filled a questionnaire after counseling. Trial decision and satisfaction with clarity of the study objectives and answering all questions were measured in women who accepted (n=265) or refused (n=192) to participate into a phase III clinical trial. Health-related and social demographic factors included age, age at menopause, 5-year Gail risk, body mass index, education, current use of HRT, regular mammographic screening, smoking habit, physical activity, use of drugs, alcohol use, concern about side effects, and physician (family doctor or gynecologist) recommendation. Psychological factors included breast cancer-related worry, absolute and comparative risk perception, anxiety and depression. Participant satisfaction with health care providers was assessed on a 5-point Likert scale. Reasons for participation or refusal were listed in a pre-specified questionnaire. Results: Most frequent reasons for entry were willingness to participate in a research program (61%), receive frequent medical care (58%), and contribute to increase medical knowledge (44%), whereas most frequent reasons for refusal included drug use (33%), concern about side effects (31%), and physician advice against (24%). In a multivariate logistic regression model, the probability of accepting to participate into the trial was significantly associated with current HRT use (OR = 9.28; 95%CI, 4.80-17.97), participant satisfaction with answering all questions (OR = 7.40; 95%CI, 3.02-18.11), no breast cancer worry (OR = 8.53; 95%CI, 1.41-50), younger age, presence of 2+ life-style risk factors (including smoking, obesity and no physical exercise) and no alcohol use. Conclusion: Participation in this chemoprevention trial reflects a proactive attitude towards health promotion and quality of life, which entails use of drugs against menopausal symptoms and no breast cancer worry. Moreover, satisfaction with health care providers underlines the importance of accurate counseling at study presentation.