The Colorectal Cancer Chemoprevention Acceleration and Improvement Platform (CRC-CHAMP) - Cohort Description.

IntroductionTherapeutic intervention with chemopreventive agents (CPA) represents a promising avenue for cancer prevention; however, additional data on patient adherence are needed. We developed the Colorectal Cancer Chemoprevention Acceleration Platform (CRC-CHAMP) and examined the feasibility of real-world CPA intervention in persons with an increased risk for CRC. Herein, we describe the recruitment, uptake, and adherence within this pilot study.MethodsFor this single-arm prospective pilot study (NCT05402124), we recruited individuals from the Forzani and MacPhail Colon Cancer Screening Centre (CCSC) in Calgary, Alberta, Canada. Eligible individuals were between the ages of 50-59 and had a history of high-risk adenomatous polyps diagnosed at the CCSC in the preceding 12 months. After consenting, each participant was provided open-label acetylsalicylic acid (ASA) at 81 mg every day for 90 days. Participants were contacted by telephone every 30 days to collect current adherence (primary outcome) and occurrence of any adverse events (secondary outcome).ResultsThroughout recruitment, 823 potential participants were identified, with 69 (53.1%) being eligible and 67 (51.5%) finally enrolling in the study. The median age of the participants was 56 yr. At the follow-ups, 60 participants (89.6%) were adherent at 30 days, 54 participants (80.6%) were adherent at 60 days, and 55 (82.1%) participants were adherent at 90 days. A total of 9 (13.4%) participants experienced minor adverse events likely unrelated to the ASA.ConclusionParticipants recruited to this pilot study had a high level of adherence throughout the 90-day period with minimal side effects. Challenges to recruitment included low response rate by mail and a high number of those contacted already taking non-steroidal anti-inflammatory drugs. This study suggests that individuals post-polypectomy of large polyp may be interested in CRC chemoprevention. Additionally, this study provides a framework for future evaluation of additional therapeutic interventions.