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

Abstract

BackgroundObservational 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.PurposeThe 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.MethodsTrial 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.SummaryCancer 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.

Physical activity and cancer prevention: a systematic review of clinical trials

“…This objective is more feasible for tertiary prevention research as demonstrated by the commencement of a large clinical trial measuring disease-free survival in colon cancer survivors during and following a 3 year exercise intervention [84]. This field of research is rapidly progressing, although the evidence for the pathways through which exercise may enhance survival is still not entirely clear.…”

Diet and Lifestyle in Survivors of Colorectal Cancer

“…50–52 Currently, there is one ongoing intervention study to specifically study disease-free survival in stage II and III colorectal cancer survivors. 50 Courneya et al 50 endeavor to study the effect of physical activity intervention over a 3-year period, and how that intervention affected recurrences, mortality, physical functioning, quality of life, and biologic correlative markers for colon cancer patients. The study is sponsored by the National Cancer Institute of Canada and has ongoing accrual in Canada and Australia.…”

Eastern Canadian Colorectal Cancer Consensus Conference: Application of New Modalities of Staging and Treatment of Gastrointestinal Cancers

“…• Survivors of colon cancer should be advised to engage in regular exercise, to follow the Canada Food Guide, to stop smoking, and to limit alcohol to moderate consumption (level iii) [21][22][23] .…”

“…The Eastern Canadian Colorectal Cancer Consensus Conference was held in Ottawa, Ontario on October [22][23]2010. The conference is held annually, and some of the terms of reference and opening statements are taken directly from a previous publication 1 .…”

“…The annual Eastern Canadian Colorectal Cancer Consensus Conference was held in Ottawa, Ontario, October [22][23]2010. Health care professionals involved in the care of patients with colorectal cancer participated in presentation and discussion sessions for the purpose of developing the recommendations presented here.…”