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

K 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, K 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 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.

Purpose: 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.

Methods: 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.

Summary: 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.

Keywords: Behavioural oncology; cancer survivor; disease-free survival; exercise; lifestyle; physical activity; quality of life; survivorship.

Figures

FIGURE 1
FIGURE 1
Flow of participants through the Colon Health and Life-Long Exercise Change (CHALLENGE) trial.

References

    1. nih Consensus Conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA. 1990;264:1444–50.
    1. André T, Boni C, Mounedji–Boudiaf L, et al. on behalf of the mosaic Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343–51.
    1. Meyerhardt JA, Heseltine D, Niedzwiecki D, et al. Impact of physical activity on cancer recurrence and survival in patients with stage iii colon cancer: findings from calgb 89803. J Clin Oncol. 2006;24:3535–41.
    1. Meyerhardt JA, Giovannucci EL, Holmes MD, et al. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006;24:3527–34.
    1. McTiernan A. Mechanisms linking physical activity with cancer. Nat Rev Cancer. 2008;8:205–11.
    1. Courneya KS, Friedenreich CM. Relationship between exercise pattern across the cancer experience and current quality of life in colorectal cancer survivors. J Altern Complement Med. 1997;3:215–26.
    1. Courneya KS, Katzmarzyk PT, Bacon E. Physical activity and obesity in Canadian cancer survivors: population-based estimates from the 2005 Canadian Community Health Survey. Cancer. 2008;112:2475–82.
    1. Look ahead Research Group. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the Look ahead trial. Diabetes Care. 2007;30:1374–83.
    1. McTiernan A, Yasui Y, Sorensen B, et al. Effect of a 12-month exercise intervention on patterns of cellular proliferation in colonic crypts: a randomized controlled trial. Cancer Epidemiol Biomarkers Prev. 2006;15:1588–97.
    1. Knowler WC, Barrett–Connor E, Fowler SE, et al. on behalf of the Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403.
    1. Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process. 1991;50:179–211.
    1. Vallance JK, Courneya KS, Plotnikoff RC, Dinu I, Mackey JR. Maintenance of physical activity in breast cancer survivors after a randomized trial. Med Sci Sports Exerc. 2008;40:173–80.
    1. Vallance JK, Courneya KS, Plotnikoff R, Mackay JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007;25:2352–9.
    1. Vallance JK, Courneya KS, Plotnikoff RC, Mackey JR. Analyzing theoretical mechanisms of physical activity behavior change in breast cancer survivors: results from the activity promotion (action) trial. Ann Behav Med. 2008;35:150–8.
    1. Sargent DJ, Wieand HS, Haller DG, et al. Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials. J Clin Oncol. 2005;23:8664–70. [See comment in J Clin Oncol 2005;23:8564–5]
    1. American College of Sports Medicine (acsm) acsm’s Guidelines for Exercise Testing and Prescription. 7. Philadelphia: Lippincott Williams and Wilkins; 2006.
    1. Rikli R, Jones J. Development and validation of a functional fitness test for community-residing older adults. J Aging Phys Act. 1999;7:129–61.
    1. Friedenreich CM, Courneya KS, Bryant HE. The Lifetime Total Physical Activity Questionnaire: development and reliability. Med Sci Sports Exerc. 1998;30:266–74.
    1. Friedenreich CM, Courneya KS, Neilson HK, et al. Reliability and validity of the Past Year Total Physical Activity Questionnaire. Am J Epidemiol. 2006;163:959–70.
    1. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the sf-36. J Health Econ. 2002;21:271–92.
    1. Canadian Cancer Society and the National Cancer Institute of Canada. Canadian Cancer Statistics 2008. Toronto: Canadian Cancer Society; 2008.

Source: PubMed

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