Hudmon K S, Stoltzfus C, Chamberlain R M, Lorimor R J, Steinbach G, Winn R J
Department of Epidemiology, University of Texas, M.D. Anderson Cancer Center, Houston 77030, USA.
Control Clin Trials. 1996 Dec;17(6):494-508. doi: 10.1016/s0197-2456(96)00063-3.
To assess participants' perceptions of a phase I colon cancer chemoprevention trial using a calcium intervention, questionnaires were mailed to trial participants at the conclusion of the study. Responses to questionnaire items reported here include (1) perceived benefits and barriers of participation, (2) interest in participating in future trials, (3) willingness to pay trial expenses out of pocket, and (4) posttrial continuation of the calcium regimen. The study found that the most highly rated trial benefit was the perception of potential colon cancer prevention; the trial barrier reported to be the most troublesome was inappropriate or mistaken billing for study visits. Three fourths of the subjects expressed an interest in future trials of the same duration. For trials of longer duration, this percentage decreased to 66%. Approximately half did not object to participation in future trials involving placebos, and just over one third indicated that they would either definitely (8%) or probably (27%) have joined the calcium trial even if they had to pay some study expenses out of pocket. Over 90% indicated they would continue taking the calcium pills if calcium is shown to be effective. The level of perceived benefits was positively associated with reported interest in participating in future trials of the same and longer durations, and the level of reported difficulty with trial pills and procedures was inversely related to interest in future placebo-controlled trials. The results of this study, in conjunction with results of prospective studies of trial participation, may be applied in future chemoprevention trials to facilitate recruitment, reduce attrition, and promote positive trial experiences for participants by emphasizing frequently reported benefits and minimizing frequently reported barriers.
为了评估参与者对一项使用钙干预的I期结肠癌化学预防试验的看法，在研究结束时向试验参与者邮寄了问卷。此处报告的对问卷项目的回答包括：（1）参与的感知益处和障碍；（2）参与未来试验的兴趣；（3）自掏腰包支付试验费用的意愿；（4）试验后钙方案的持续使用情况。研究发现，评价最高的试验益处是对潜在结肠癌预防的感知；报告最麻烦的试验障碍是研究访视的计费不当或错误。四分之三的受试者表示对相同持续时间的未来试验感兴趣。对于持续时间更长的试验，这一比例降至66%。约一半的人不反对参与未来涉及安慰剂的试验，略超过三分之一的人表示，即使他们不得不自掏腰包支付一些研究费用，他们肯定（8%）或可能（27%）会参加钙试验。超过90%的人表示，如果钙被证明有效，他们会继续服用钙片。感知益处的程度与报告的参与相同和更长持续时间未来试验的兴趣呈正相关，报告的试验药物和程序困难程度与未来安慰剂对照试验的兴趣呈负相关。这项研究的结果，结合试验参与的前瞻性研究结果，可应用于未来的化学预防试验，通过强调经常报告的益处并尽量减少经常报告的障碍，促进招募、减少损耗，并为参与者带来积极的试验体验。
