Zahrieh David, Strand Carrie A, Limburg Paul J, Jatoi Aminah, Mandrekar Sumithra J
Mayo Clinic, Rochester, United States.
Mayo Clinic College of Medicine, Rochester, MN, United States.
Cancer Prev Res (Phila). 2025 Sep 3. doi: 10.1158/1940-6207.CAPR-25-0180.
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.
目的是评估受试者对早期化学预防试验的参与情况是否令人满意，并确定与受试者满意度相关的特征。纳入了癌症预防网络在2006年至2021年期间研究一系列候选药物的13项试验。在每项试验干预结束时或提前终止时，对所有受试者进行5项“是否值得？”（WIWI）问卷调查。总体满意定义为参与者对前三个问题回答“是”。来自美国、加拿大、波多黎各和洪都拉斯的691名参与者参加了一项试验。652名（94.4%）完成了WIWI问卷调查。其中，493名（75.6%）为非西班牙裔/拉丁裔白人；39名（6.0%）为非西班牙裔/拉丁裔黑人；98名（15.0%）为西班牙裔/拉丁裔；8名（1.2%）属于其他种族/族裔。193名是女性（29.6%），121名（17.5%）年龄≥65岁，517名（79.3%）参加了安慰剂对照试验。85%的人表示总体满意。与非西班牙裔/拉丁裔白人相比，非西班牙裔/拉丁裔黑人/亚裔/多种族总体不满意的几率高2.96倍（P<0.001），西班牙裔/拉丁裔总体不满意的几率低0.40倍（P=0.004）。干预前经历的不良事件（AE）数量≥1时，总体不满意的几率高1.9倍（P=0.012）；AE发生时间占干预持续时间的百分比>5%时，总体不满意的几率高1.8倍（P=0.024）；提前终止干预的受试者总体不满意的几率高7.4倍（P<0.001）。这些发现可为未来化学预防试验的设计提供参考，并帮助研究人员在这个未充分探索的研究环境中提高入组率、保留率、依从性和多样性。
