Was It Worth It? Response Data from >650 US and International Participants in Chemoprevention Trials

The aim was to assess whether subject's participation in early-phase chemoprevention trials was satisfactory and identify features associated with subjects' satisfaction. Thirteen trials that investigated a range of candidate agents from 2006 to 2021 by the Cancer Prevention Network were included. The five-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 questionnaire. 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/>1 race, 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 experienced was ≥1 (P = 0.012), 1.8 times higher when the percentage of the intervention duration with adverse events 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.

The five-item "WIWI?" questionnaire, which captures the participant-reported experience of trial participation, gives the subject a voice in the development of new chemopreventative agents. This study in 652 subjects looked at satisfaction with participation in early-phase chemoprevention trials for higher-risk, cancer-free men and women. See related Spotlight, p. 7.