Tamoxifen for the prevention of breast cancer: Psychosocial impact on women participating in two randomized controlled trials

Purpose: The purpose of this study was to evaluate the psychosocial implica tions of tamoxifen versus placebo in women who are at increased risk of bre ast cancer. Patients and Methods: The 488 women in the psychosocial study were recruite d from participants in two placebo-controlled, double-blind, randomized, co ntrolled trials that investigated the efficacy of tamoxifen in tire prevent ion of breast cancer in women who are at high familial risk. During a 5-yea r period, repeated assessments were made of anxiety, psychological distress , and sexual functioning using standardized questionnaires before treatment at baseline and at 6-month intervals during the trial. Results: Questionnaire completion over 5 years was good, with 71.1% of wome n returning at least 8 of 10 follow-up assessments. Although scores from in dividuals showed considerable fluctuation and variation over time, changes in anxiety, mood, and sexual functioning were not associated with treatment group. The number of symptoms reported at 48 months via a self-report chek list were not associated with treatment group, but vasomotor symptoms were more frequent among tamoxifen-treated women. Symptoms of low energy, breast sensitivity, and visual blurring were reported most frequently in the plac ebo group. Conclusion: In general, these results are comparable to those from the Nati onal Surgical Adjuvant Breast and Bowel project psychosocial study despite differences in study populations, methodology, and instruments. The long-te rm use of tamoxifen and other selective estrogen response modulators as pre ventive agents in highrisk groups has been questioned, but we found no evid ence of treatment-related side effects that affect women's psychosocial and sexual functioning. (C) 2001 by American Society of Clinical Oncology.