The Colon Health and Life-Long Exercise Change (CHALLENGE) trial (CO.21)

Kerry S. Courneya, C.M. Booth, S. Gill, P. O’Brien, J. Vardy, C.M. Friedenreich, H.J. Au, M.D. Brundage, D. Tu, H. Dhillon, R.M. Meyer


Background: Observational studies indicate that physical activity (PA) is strongly associated with disease outcomes in colon cancer survivors but a randomized controlled trial is needed to determine whether the association is causal and whether new policies to promote exercise are justified. Purpose: The National Cancer Institute of Canada Clinical Trials Group’s (NCIC CTG) CO.21 Colon Health And Life-Long Exercise ChaNGE (CHALLENGE) trial is designed to determine the effects of a structured PA intervention on outcomes of survivors of high-risk stage II or stage III colon cancer who have completed adjuvant therapy within the previous 2-6 months. Methods: Trial participants (N=962) will be stratified by center, disease stage, body mass index, and performance status and randomly assigned to a structured PA intervention or general health education materials. The PA intervention will consist of a behavioral support program and supervised PA sessions delivered over a 3-year period, beginning with regular face-to-face sessions and tapering to less frequent face-to-face or telephone sessions. The primary endpoint is disease-free survival. Important secondary endpoints include multiple patient-reported outcomes, objective physical functioning, biologic correlative markers, and an economic analysis. Conclusion: There is significant interest among cancer survivors and cancer care professionals about the potential role of PA to improve multiple disease-related outcomes, but a randomized controlled trial is needed to provide compelling evidence to justify changes in health care policies and practice.

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ISSN: 1198-0052 (Print) ISSN: 1718-7729 (Online)