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

Abstract


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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DOI: http://dx.doi.org/10.3747/co.v15i6.378





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