Document Detail


Tamoxifen for the prevention of breast cancer: psychosocial impact on women participating in two randomized controlled trials.
MedLine Citation:
PMID:  11283119     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: 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. PATIENTS AND 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. CONCLUSION: 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.
Authors:
L Fallowfield; A Fleissig; R Edwards; A West; T J Powles; A Howell; J Cuzick
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  19     ISSN:  0732-183X     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2001 Apr 
Date Detail:
Created Date:  2001-04-03     Completed Date:  2001-05-03     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1885-92     Citation Subset:  IM    
Affiliation:
Cancer Research Campaign Psychosocial Oncology Group, University of Sussex, United Kingdom. l.fallowfield@bids.susx.ac.uk
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Anxiety / chemically induced
Breast Neoplasms / prevention & control*
Case-Control Studies
Chemoprevention / psychology
Estrogen Antagonists / adverse effects*
Female
Humans
Middle Aged
Odds Ratio
Randomized Controlled Trials as Topic
Regression Analysis
Sexual Behavior
Sexual Dysfunction, Physiological / chemically induced*
Statistics, Nonparametric
Stress, Psychological / chemically induced*
Tamoxifen / adverse effects*
Chemical
Reg. No./Substance:
0/Estrogen Antagonists; 10540-29-1/Tamoxifen

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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