Patient-Reported Outcomes And Behavioral Risk Factors As Predictors Of Chemoprevention Adherence Among Women In The National Surgical Adjuvant Breast And Bowel Program (Nsabp) Breast Cancer Prevention P-1 Trial.

1512 Background: Despite a 50% reduction in the risk of breast cancer (BC) for tamoxifen (T) vs. placebo (P), many women at risk of BC do not adhere to the 5 year course. Using prospectively-collected data from the double-blind NSABP P-1, we evaluated whether patient-reported outcomes were associated with drug adherence, and whether baseline behavioral risk factors modified those associations. Methods: 13,338 women at high risk of BC were randomly assigned to T vs. P (20 mg/day); we analyzed the 11,064 enrolled more than 3 years before trial unblinding 5/98. Mixed effects logistic regression was used to evaluate whether baseline and 3-month (mo) SF-36 mental (MCS) and physical (PCS) quality of life scales, depressive symptoms (CES-D), and possible treatment-related symptoms (BCPT symptom scales) predicted 12-mo drug adherence (using over 75% of assigned medication), accounting for Gail model estimated breast cancer risk and education; and whether associations were modified by baseline smoking status, alco...