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- Title
Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1.
- Authors
Land, Stephanie R.; Walcott, Farzana L.; Qing Liu; Wickerham, D. Lawrence; Costantino, Joseph P.; Ganz, Patricia A.; Liu, Qing
- Abstract
<bold>Background: </bold>Tamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations.<bold>Methods: </bold>P-1 participants were randomly assigned to placebo vs tamoxifen (20mg/day). Mixed effects logistic regression was used to evaluate whether baseline or three-month SF-36 quality of life (QOL) mental and physical component summaries (MCS, PCS), and participant-reported symptoms (gynecologic, vasomotor, sexual, and other) predicted 12-month drug adherence (76-100% of assigned medication). The evaluation accounted for age, treatment, estimated breast cancer risk, education, baseline smoking, alcohol consumption, and obesity. All statistical tests were two-sided.<bold>Results: </bold>Participants enrolled at least three years before trial unblinding and without medically indicated discontinuation before 12 months were eligible for the present analyses (n = 10 576). At 12 months, 84.3% were adherent. Statistically significant predictors of adherence were: three-month MCS (odds ratio [OR] = 1.15 per 10 points, 95% confidence interval [CI] = 1.06 to 1.25); three-month gynecologic symptoms among moderate alcohol drinkers (OR = .79, 95% CI = 0.72 to 0.88); baseline vasomotor symptoms among participants assigned tamoxifen (OR = .88, 95% CI = 0.80 to 0.97); and three-month sexual symptoms among younger participants (OR = .89 at age 41 years, 95% CI = 0.80 to 0.99). The strongest association was with three-month other symptoms (OR = .77, 95% CI = 0.63 to 0.93). PCS was not associated with adherence. Symptom and QOL associations were not modified by smoking or obesity.<bold>Conclusions: </bold>Promoting QOL and managing symptoms early in therapy may be important strategies to improve adherence.
- Subjects
CHEMOPREVENTION; QUALITY of life; BREAST cancer; METASTATIC breast cancer; TAMOXIFEN; BREAST tumor prevention; ANTINEOPLASTIC agents; COMPARATIVE studies; ALCOHOL drinking; DRUGS; DRUG administration; FEMALE reproductive organs; HEALTH surveys; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; OBESITY; PATIENT compliance; PREVENTIVE health services; QUESTIONNAIRES; RESEARCH; RISK assessment; SELF-evaluation; SMOKING; SYMPATHETIC nervous system; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; ODDS ratio
- Publication
JNCI: Journal of the National Cancer Institute, 2016, Vol 108, Issue 4, p1
- ISSN
0027-8874
- Publication type
journal article
- DOI
10.1093/jnci/djv365