title: Post-study aspirin intake and factors motivating participation in a colorectal cancer chemoprevention trial.
abstract: We conducted an exploratory, cross-sectional study examining motivators for study participation and post-study aspirin intake in a chemoprevention trial. The parent clinical trial aimed to determine the optimal aspirin dose for colorectal cancer chemoprevention using prostaglandin E(2) as a mucosal biomarker. This trial was randomized and double-blinded in 60 subjects with prior sporadic colorectal adenoma(s) and evaluated three aspirin doses or placebo taken once daily for 4 weeks. A cross-section of 55 evaluable participants who completed the chemoprevention trial were mailed a 16-item, self-administered questionnaire evaluating subject demographics, motivational factors, and health-related behaviors within the framework of Pender's Health Promotion Model (HPM). Forty-three (78%) of 55 participants returned the questionnaire. The most important motivators for study participation were altruistic, i.e., a desire to help future generations at risk of colorectal cancer and personal factors including a desire to reduce one's own risk. Nineteen (44%) of 43 respondents reported that they chose to take daily aspirin post-study without knowledge of study results. At a mean follow-up of 17.3 months, 18 of these 19 subjects continued to take aspirin regularly. Regular use of vitamin supplements pre-study was found to correlate with post-study aspirin use (Mann-Whitney U test, U = 154.0; P = 0.04). We demonstrate, for the first time, that participation in a chemoprevention study can influence the decision to continue the study drug, if available, to reduce perceived cancer risk. Continued post-study aspirin intake indicates an impact of study participation on a health-related behavior and underscores the importance of patient education to guide such decision-making.
authors.affiliation: Department of Gastrointestinal Medicine and Nutrition, The University of Texas M. D. Anderson Cancer Center, and The University of Texas Health Science Center at Houston, School of Public Health, Houston, Texas 77030, USA.
authors.forename: Dory A
authors.initials: DA
authors.lastname: Sample
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Sinicrope
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Wargovich
authors.forename: Frank A
authors.initials: FA
authors.lastname: Sinicrope
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000008:administration & dosage*; D015179:Colorectal Neoplasms / Q000517:prevention & control*; D003430:Cross-Sectional Studies; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D005260:Female; D015438:Health Behavior; D006801:Humans; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010358:Patient Participation / Q000523:psychology* / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires
chemical_list: D016861:Cyclooxygenase Inhibitors; D001241:Aspirin