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
NCT ID: NCT00819208
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
889 participants
INTERVENTIONAL
2009-06-02
2030-12-15
Brief Summary
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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.
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Detailed Description
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Primary
* To compare the disease-free survival (DFS) of medically fit patients who have completed surgical resection and adjuvant chemotherapy for high-risk stage II or stage III colon cancer when administered a physical activity program with general health education materials vs general health education materials alone.
Secondary
* To compare the two intervention arms with respect to overall survival (OS); patient-reported outcomes using the SF-36, FACIT-F, PSQI, and HADS questionnaires; objective markers of physical fitness using body mass index, hip and waist circumference, submaximal exercise testing, and the Seniors' Fitness Test; physical activity behavior using the Total Physical Activity Questionnaire (TPAQ); safety profile as assessed by NCI CTCAE version 3.0; serum levels of insulin (i.e., IGF-1, IGF-2, and IGFBP3); cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF) and C-reactive protein levels; economic evaluations including cost-effective and cost-utility analyses; and predictors of physical activity adherence using the Social-Cognitive Determinants of Exercise Measure questionnaire.
* To evaluate the potential prognostic associations of the serum levels of insulin, IGF-1, IGF-2, IGFBP3, blood glucose, cytokines (i.e., IL- 1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein with DFS, OS, level of physical activity, and level of fatigue in these patients.
* To evaluate the potential prognostic associations of age, gender, country, incremental increase in physical activity, and change in cardiovascular fitness with DFS, OS, level of fatigue, and quality of life in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III), participating center, body mass index (≤ 27.5 vs \> 27.5), and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment interventions.
* Arm I: Patients receive general health education materials regarding nutrition and physical activity and undergo the Colon Health And Life Long Exercise Change (CHALLENGE) physical activity program consisting of behavior-support sessions and supervised physical activity sessions with a physical activity consultant.
* Part I (intensive intervention for 6 months): Patients undergo 12 mandatory biweekly face-to-face behavior support sessions combined with 12 mandatory supervised physical activity sessions to increase their physical activity goal by 10 metabolic equivalent task (MET) hours/week. Twelve supervised physical activity sessions are also recommended on alternate weeks.
* Part II (reduced intervention for months 6-12): Patients undergo 12 mandatory biweekly face-to-face or telephone behavior support sessions combined with 12 recommended supervised physical activity sessions to increase their physical activity goal by 20 MET hours/week.
* Part III (minimal intervention for months 12-36): Patients undergo mandatory monthly face-to-face or telephone behavior support sessions combined with recommended supervised physical activity sessions to increase their physical activity goal to a maximum total of 27 MET hours/week.
* Arm II: Patients receive general health education materials regarding nutrition and physical activity.
Patients complete the Total Physical Activity Questionnaire (TPAQ) to assess exercise participation and undergo fitness testing periodically by the submaximal exercise test and Seniors' Fitness Test (SFT).
Patients complete the SF-36, FACT-F, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Social Cognitive Determinants of Exercise Measure questionnaires periodically. Patients also complete a 30-day resource use diary and undergo a health economics analysis by the Work Productivity and Activity Impairment (WPAI) questionnaire.
Blood samples are collected periodically for correlative studies and fasting glucose. Samples are analyzed for markers of insulin level, IGF-1, IGF-2, and IGFBP3, cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein levels.
During the 3 year intervention period, patients are followed every 6 months for 3 years and then annually for 4-10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Physical Activity Program + General Health Education Materials
Intervention Arm
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
Fitness testing
Objective fitness testing for both arms
General Health Education Materials
Control Arm
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Completely resected histologically confirmed adenocarcinoma of the colon
* High-risk stage II disease, including one of the following:
* T4 lesions
* Less than 12 sampled lymph nodes
* Poorly differentiated histology
* Stage III disease, defined as having at least one pathologically confirmed positive lymph node or one pathologically confirmed positive tumour deposit.
* Synchronous primary colon cancer allowed
* Adjuvant chemotherapy treatment for colon cancer with a 5-fluorouracil- based regimen received with an intent to provide a complete course of treatment. While one current standard is 24 weeks of treatment, patients who are pre-planned to receive a shorter duration of chemotherapy, including as part of a research study will also be permitted. The actual treatment received may be less than 24 weeks; participants must have received a minimum of one treatment cycle.
* Chemotherapy must have been completed (i.e. last dose received) a minimum of 60 days and a maximum of 180 days prior to registration.
* Carcinoembryonic antigen (CEA) ≤ 5 μg/L
* Current physical activity levels do not meet the recommended guidelines (≥ 150 minutes of moderate-to-vigorous or ≥ 75 minutes of vigorous physical activity/week) as calculated using the Leisure Time Exercise Questionnaire (LTEQ)
* Completion of chest x-ray or CT, and CT, MRI or ultrasound of abdomen within 60 days of registration; these imaging tests must not show evidence of metastatic or locally-recurrent colon cancer.
* Complete one of the following: (a) at least 2 stages of the submaximal exercise test with an acceptable heart rate and blood pressure response as defined in Appendix XII or (b) the 6 minute walk test with an acceptable heart rate and blood pressure response
* No rectal cancer
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Absolute granulocyte count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 100 g/L
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase \< 2.5 times ULN
* ALT \< 2 times ULN
* Not pregnant or planning to become pregnant within the next 3 years
* Able (i.e., sufficiently fluent) and willing to effectively communicate with the physical activity consultant affiliated with the originating cancer center
* Able (i.e., sufficiently fluent in English or French) and willing to complete the patient-reported outcome questionnaires, social determinants of exercise measurement, health economics, and physical activity questionnaires and logs
* Able to complete the baseline exercise test
* No significant comorbid conditions precluding participation in a physical activity program as determined by the investigator
* Likely to participate in a physical activity program, as assessed by the investigator
* No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, other solid tumors, Hodgkin lymphoma, or non-Hodgkin lymphoma curatively treated with no evidence of disease for \> 5 years
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy as a component of treatment for primary tumor
* No concurrent treatment with additional chemotherapy or radiation
* No concurrent treatment with any medications deemed by the investigator as likely to preclude participation in a physical activity program
* No concurrent anticancer treatment including chemotherapy, biological, or targeted agents
18 Years
ALL
No
Sponsors
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Survivorship Research Group
UNKNOWN
Queen's University, Belfast
OTHER
Canadian Cancer Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Kerry Courneya, PhD
Role: STUDY_CHAIR
University of Alberta
Christopher Booth, MD
Role: STUDY_CHAIR
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Janette Vardy, PhD, FRACP
Role: STUDY_CHAIR
Sydney Cancer Centre at Concord Repatriation General Hospital
Locations
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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
Countries
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References
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Courneya KS, Booth CM, Gill S, O'Brien P, Vardy J, Friedenreich CM, Au HJ, Brundage MD, Tu D, Dhillon H, Meyer RM. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group. Curr Oncol. 2008 Dec;15(6):279-85. doi: 10.3747/co.v15i6.378.
Vallance J, Lesniak SL, Belanger LJ, Courneya KS. Development and assessment of a physical activity guidebook for the Colon Health and Life-Long Exercise Change (CHALLENGE) trial (NCIC CO.21). J Phys Act Health. 2010 Nov;7(6):794-801. doi: 10.1123/jpah.7.6.794.
Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreich CM, Campbell KL, Prapavessis H, Crawford JJ, O'Brien P, Dhillon HM, Jonker DJ, Chua NS, Lupichuk S, Sanatani MS, Gill S, Meyer RM, Begbie S, Bonaventura T, Burge ME, Turner J, Tu D, Booth CM. Effects of a Structured Exercise Program on Physical Activity and Fitness in Colon Cancer Survivors: One Year Feasibility Results from the CHALLENGE Trial. Cancer Epidemiol Biomarkers Prev. 2016 Jun;25(6):969-77. doi: 10.1158/1055-9965.EPI-15-1267. Epub 2016 Apr 8.
Courneya KS, Vardy JL, O'Callaghan CJ, Gill S, Friedenreich CM, Wong RKS, Dhillon HM, Coyle V, Chua NS, Jonker DJ, Beale PJ, Haider K, Tang PA, Bonaventura T, Wong R, Lim HJ, Burge ME, Hubay S, Sanatani M, Campbell KL, Arthuso FZ, Turner J, Meyer RM, Brundage M, O'Brien P, Tu D, Booth CM; CHALLENGE Investigators. Structured Exercise after Adjuvant Chemotherapy for Colon Cancer. N Engl J Med. 2025 Jul 3;393(1):13-25. doi: 10.1056/NEJMoa2502760. Epub 2025 Jun 1.
Other Identifiers
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CAN-NCIC-CO21
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000629834
Identifier Type: OTHER
Identifier Source: secondary_id
CO21
Identifier Type: -
Identifier Source: org_study_id
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