title: Participants' perceptions of a phase I colon cancer chemoprevention trial.
abstract: 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.
authors.affiliation: Department of Epidemiology, University of Texas, M.D. Anderson Cancer Center, Houston 77030, USA.
authors.forename: K S
authors.initials: KS
authors.lastname: Hudmon
authors.forename: C
authors.initials: C
authors.lastname: Stoltzfus
authors.forename: R M
authors.initials: RM
authors.lastname: Chamberlain
authors.forename: R J
authors.initials: RJ
authors.lastname: Lorimor
authors.forename: G
authors.initials: G
authors.lastname: Steinbach
authors.forename: R J
authors.initials: RJ
authors.lastname: Winn
mesh_terms: D000230:Adenocarcinoma / Q000517:prevention & control*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001290:Attitude; D002119:Calcium Carbonate / Q000627:therapeutic use; D019355:Calcium Citrate / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic / Q000191:economics; D003110:Colonic Neoplasms / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D018709:Statistics, Nonparametric
chemical_list: D002119:Calcium Carbonate; D019355:Calcium Citrate