TY - JOUR
T1 - A randomized phase II dose–response exercise trial among colon cancer survivors
T2 - Purpose, study design, methods, and recruitment results
AU - Brown, Justin C.
AU - Troxel, Andrea B.
AU - Ky, Bonnie
AU - Damjanov, Nevena
AU - Zemel, Babette S.
AU - Rickels, Michael R.
AU - Rhim, Andrew D.
AU - Rustgi, Anil K.
AU - Courneya, Kerry S.
AU - Schmitz, Kathryn H.
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016
Y1 - 2016
N2 - Background 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. Methods/results The primary objective of the COURAGE trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week−1) and high-dose (300 min·week−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, 1433 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. Discussion 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.
AB - Background 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. Methods/results The primary objective of the COURAGE trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week−1) and high-dose (300 min·week−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, 1433 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. Discussion 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.
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U2 - 10.1016/j.cct.2016.03.001
DO - 10.1016/j.cct.2016.03.001
M3 - Article
C2 - 26970181
AN - SCOPUS:84982255245
SN - 1551-7144
VL - 47
SP - 366
EP - 375
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -