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ACTIVE NOT RECRUITING
NCT00819208
NA

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

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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

OTHER

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.

OTHER

educational intervention

Once at the beginning of the program

OTHER

laboratory biomarker analysis

Every 12 months

OTHER

questionnaire administration

Every 6 months

OTHER

study of socioeconomic and demographic variables

Every 6 months

PROCEDURE

fatigue assessment and management

Every 6 months

PROCEDURE

quality-of-life assessment

Every 6 months

OTHER

Educational Intervention

For Arm 2 just once at beginning of program.

OTHER

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