Was it Worth It? Response Data from >650 United States and International Participants in Chemoprevention Trials.

The aim was to assess whether subject's participation in early-phase chemoprevention trials was satisfactory and to identify features associated with subjects' satisfaction. Thirteen trials that investigated a range of candidate agents from 2006-2021 by the Cancer Prevention Network were included. The 5-item "Was It Worth It?" (WIWI) questionnaire was administered to all subjects at the end of each trial's intervention or at early termination. Satisfied overall was defined as a participant response of "yes" to the first three questions. Six hundred ninety-one participants from the United States, Canada, Puerto Rico, and Honduras enrolled on a trial. Six hundred fifty-two (94.4%) completed the WIWI. Of these, 493 (75.6%) were White, non-Hispanic/Latino; 39 (6.0%) Black, non-Hispanic/Latino; 98 (15.0%) Hispanic/Latino; and 8 (1.2%) of another race/ethnicity. One hundred ninety-three were women (29.6%), 121 (17.5%) were ≥65 years, and 517 (79.3%) participated in a placebo-controlled trial. Eighty-five percent indicated being satisfied overall. Compared with White, non-Hispanic/Latino, the odds of not satisfied overall were 2.96 times higher for Black/Asian/>1race, non-Hispanic/Latino (P<0.001) and 0.40 times lower for Hispanic/Latino (P=0.004). The odds of not satisfied overall was 1.9 times higher when the number of preintervention adverse events (AEs) experienced was ≥1 (P=0.012); 1.8 times higher when the percentage of the intervention duration with AEs was >5% (P=0.024); and 7.4 times higher for subjects who terminated the intervention early (P<0.001). These findings can inform the design of future chemoprevention trials and help investigators improve accrual, retention, adherence, and diversity in this underexplored research setting.