title: A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA. Electronic address: brownjus@mail.med.upenn.edu.
authors.forename: Justin C
authors.initials: JC
authors.lastname: Brown
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Andrea B
authors.initials: AB
authors.lastname: Troxel
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Bonnie
authors.initials: B
authors.lastname: Ky
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Nevena
authors.initials: N
authors.lastname: Damjanov
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA; Children's Hospital of Philadelphia, Philadelphia, PA, USA.
authors.forename: Babette S
authors.initials: BS
authors.lastname: Zemel
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Rickels
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Rhim
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Anil K
authors.initials: AK
authors.lastname: Rustgi
authors.affiliation: University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Kerry S
authors.initials: KS
authors.lastname: Courneya
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Kathryn H
authors.initials: KH
authors.lastname: Schmitz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003110:Colonic Neoplasms / Q000503:physiopathology / Q000628:therapy*; D015444:Exercise / Q000502:physiology; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011788:Quality of Life; D012107:Research Design; D017741:Survivors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Energy balance; Lifestyle; Obesity; Physical activity; Quality-of-life; Survivorship