The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group.
The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group.
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DOI：
10.3747/co.v15i6.378
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发表时间：
2008-12
期刊：
影响因子：
--
通讯作者：
Meyer RM
中科院分区：
文献类型：
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作者：
Courneya KS;Booth CM;Gill S;O'Brien P;Vardy J;Friedenreich CM;Au HJ;Brundage MD;Tu D;Dhillon H;Meyer RM
观察性研究表明，体育活动（pa）与结肠癌幸存者疾病预后的改善密切相关，但需要一项随机对照试验来确定这种关联是否存在因果关系，以及促进运动的新政策是否合理。由加拿大国家癌症研究所临床试验组（ncic ctg）进行的co.21结肠健康和终身运动改变（挑战）试验旨在确定结构化pa干预对高危ii期或iii期结肠癌患者在过去2-6个月内完成辅助治疗的结果的影响。试验参与者（n = 962）将按中心、疾病分期、体重指数和表现状况进行分层，并将随机分配到结构化pa干预组或普通健康教育材料组。pa干预将包括一个行为支持计划和监督pa会议，为期三年，从定期面对面会议开始，逐渐减少面对面会议或电话会议。主要终点是无病生存期。重要的次要终点包括多个患者报告的结果、客观身体功能、生物相关标志物和经济分析。癌症幸存者和癌症护理专业人员对PA在改善多种疾病相关结局方面的潜在作用很感兴趣，但需要一项随机对照试验来提供令人信服的证据，以证明医疗保健政策和实践的改变是合理的。
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.