A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.
A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.
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DOI：
10.1016/j.cct.2016.03.001
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发表时间：
2016-03
影响因子：
2.2
通讯作者：
Schmitz KH
中科院分区：
文献类型：
--
作者：
Brown JC;Troxel AB;Ky B;Damjanov N;Zemel BS;Rickels MR;Rhim AD;Rustgi AK;Courneya KS;Schmitz KH
观察性研究表明，在结肠癌幸存者中，更高的体力活动量与改善的疾病结局相关。这份报告的目的是描述COURANT试验的目的、研究设计、方法和招募结果，COURANT试验是美国国家癌症研究所（NCI）在结肠癌幸存者中发起的II期、随机、剂量反应运动试验。COUperson试验的主要目的是量化低剂量（150 min·wk−1）和高剂量（300 min·wk−1）中等强度有氧运动与常规护理对照组相比的可行性，安全性和生理效应。运动小组配备了家用跑步机和心率监测器。在2015年1月至7月期间，使用基于人群的国家癌症登记处邮寄了1，433封信件; 126名结肠癌幸存者询问了参与情况，39名被随机分配到研究方案中。年龄与研究参与（P<0.001）和研究方案随机化（P<0.001）相关。没有其他人口统计学、临床或地理特征与研究询问或随机化相关。最后一名试验参与者于2015年8月接受随机化。6个月终点数据收集于2016年2月完成。招募结肠癌幸存者参加运动试验是可行的。这项试验的结果将为未来的2期和3期随机对照试验提供关键设计方面的信息，以检查运动改善结肠癌幸存者临床结局的疗效。
Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the COURAGE trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. The primary objective of the COURAGE trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·wk−1) and high-dose (300 min·wk−1) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1,433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (P<0.001) and randomization onto the study protocol (P<0.001). No other demographic, clinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors.