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

[摘要] Background : O bservational 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.21C olonH ealthA ndL ife- L ongE xercise Cha NGE(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.

[学科分类] 肿瘤学