Tamoxifen for the prevention of breast cancer: psychosocial impact on women participating in two randomized controlled trials.
OBJECTIVE
The purpose of this study was to evaluate the psychosocial implications of tamoxifen versus placebo in women who are at increased risk of breast cancer.


METHODS
The 488 women in the psychosocial study were recruited from participants in two placebo-controlled, double-blind, randomized, controlled trials that investigated the efficacy of tamoxifen in the prevention of breast cancer in women who are at high familial risk. During a 5-year 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 women returning at least 8 of 10 follow-up assessments. Although scores from individuals 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 checklist 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 placebo group.


CONCLUSIONS
In general, these results are comparable to those from the National Surgical Adjuvant Breast and Bowel Project psychosocial study despite differences in study populations, methodology, and instruments. The long-term use of tamoxifen and other selective estrogen response modulators as preventive agents in high-risk groups has been questioned, but we found no evidence of treatment-related side effects that affect women's psychosocial and sexual functioning.
Fallowfield
L
L
Cancer Research Campaign Psychosocial Oncology Group, University of Sussex, United Kingdom. l.fallowfield@bids.susx.ac.uk
Fleissig
A
A
Edwards
R
R
West
A
A
Powles
T J
TJ
Howell
A
A
Cuzick
J
J
D000328:Adult; D000368:Aged; D001007:Anxiety / Q000139:chemically induced; D001943:Breast Neoplasms / Q000517:prevention & control*; D016022:Case-Control Studies; D018890:Chemoprevention / Q000523:psychology; D004965:Estrogen Antagonists / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008875:Middle Aged; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D012725:Sexual Behavior; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced*; D018709:Statistics, Nonparametric; D013315:Stress, Psychological / Q000139:chemically induced*; D013629:Tamoxifen / Q000009:adverse effects*
D004965:Estrogen Antagonists; D013629:Tamoxifen