The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group

• Published in: Current oncology (Toronto) Vol. 15; no. 6; pp. 279 - 278
• Main Authors: Courneya, K S, Booth, C M, Gill, S, O'Brien, P, Vardy, J, Friedenreich, C M, Au, H J, Brundage, M D, Tu, D, Dhillon, H, Meyer, R M
• Format: Journal Article
• Language: English
• Published: Canada Multimed Inc 01-12-2008
• Subjects: Cancer Rehabilitation and Survivorship; survivorship; disease-free survival; exercise; quality of life; Behavioural oncology; cancer survivor; lifestyle; physical activity
• ISSN: 1198-0052; 1718-7729

Observational studies indicate that physical activity (PA) is strongly associated with improved 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.
The co.21 Colon Health and Life-Long Exercise Change (challenge) trial undertaken by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) is designed to determine the effects of a structured pa intervention on outcomes for survivors of high-risk stage II or III colon cancer who have completed adjuvant therapy within the previous 2-6 months.
Trial participants (n = 962) will be stratified by centre, disease stage, body mass index, and performance status, and will be randomly assigned to a structured pa intervention or to general health education materials. The pa intervention will consist of a behavioural 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.
Cancer survivors and cancer care professionals are interested in 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.