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Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer
Sponsor: Canadian Cancer Trials Group
Summary
RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment. PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.
Official title: A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
889
Start Date
2009-06-02
Completion Date
2030-12-15
Last Updated
2025-09-16
Healthy Volunteers
No
Conditions
Interventions
exercise intervention
3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36
counseling intervention
Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.
educational intervention
Once at the beginning of the program
laboratory biomarker analysis
Every 12 months
questionnaire administration
Every 6 months
study of socioeconomic and demographic variables
Every 6 months
fatigue assessment and management
Every 6 months
quality-of-life assessment
Every 6 months
Educational Intervention
For Arm 2 just once at beginning of program.
Fitness testing
Objective fitness testing for both arms
Locations (47)
Henry Ford Hospital
Detroit, Michigan, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Armidale Hospital
Armidale, New South Wales, Australia
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
North Coast Cancer Institute Coffs Harbour
Coffs Harbour, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Newcastle Private Hospital
Newcastle, New South Wales, Australia
North Coast Cancer Institute - Port Macquarie
Port Macquarie, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Tamworth Hospital
Tamworth, New South Wales, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Princess Alexandra
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Macarthur Cancer Therapy Centre - Campbelltown Hospital
Campbelltown, Australia
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Horizon Health Network
Fredericton, New Brunswick, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
Regional Health Authority B, Zone 2
Saint John, New Brunswick, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, Canada
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Niagara Health System
St. Catharines, Ontario, Canada
Toronto Rehab
Toronto, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Sinai Health System
Toronto, Ontario, Canada
Lévis, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Montpellier, France
Exercise Medicine Center for Diabetes and Cancer
Seoul, South Korea
Belfast City Hospital
Belfast, Co. Antrim, United Kingdom