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NCT00819208Completed

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

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

Source: ClinicalTrials.gov · Last updated 24 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
889 (actual)
First submitted
7 Jan 2009
Start date
2 Jun 2009
Primary completion date
7 Feb 2025
Lead sponsor
Canadian Cancer Trials Group
NCT number
NCT00819208

What you commit to

  • Study type: Interventional
  • Participants enrolled: 889
  • From 2 Jun 2009 to the primary completion date, 7 Feb 2025
  • 47 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • DISEASE CHARACTERISTICS:
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Armidale Hospital
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ArmidaleAustraliaUnknown status
Bankstown-Lidcombe Hospital
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BankstownAustraliaUnknown status
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Macarthur Cancer Therapy Centre - Campbelltown Hospital
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CampbelltownAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
North Coast Cancer Institute Coffs Harbour
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Coffs HarbourAustraliaUnknown status
Concord Repatriation General Hospital
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ConcordAustraliaUnknown status
St Vincent's Hospital Melbourne
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FitzroyAustraliaUnknown status
Royal Brisbane and Women's Hospital
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HerstonAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Newcastle Private Hospital
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NewcastleAustraliaUnknown status
Royal Perth Hospital
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PerthAustraliaUnknown status
North Coast Cancer Institute - Port Macquarie
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Port MacquarieAustraliaUnknown status
Royal North Shore Hospital
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St LeonardsAustraliaUnknown status
Tamworth Hospital
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TamworthAustraliaUnknown status
Riverina Cancer Care Centre
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Wagga WaggaAustraliaUnknown status
Sydney Adventist Hospital
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WahroongaAustraliaUnknown status
The Queen Elizabeth Hospital
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WoodvilleAustraliaUnknown status
Princess Alexandra
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WoolloongabbaAustraliaUnknown status
Tom Baker Cancer Centre
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
Horizon Health Network
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FrederictonCanadaUnknown status
Juravinski Cancer Centre at Hamilton Health Sciences
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HamiltonCanadaUnknown status
Kingston Health Sciences Centre
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KingstonCanadaUnknown status
Grand River Regional Cancer Centre
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KitchenerCanadaUnknown status
-
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LévisCanadaUnknown status
London Regional Cancer Program
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LondonCanadaUnknown status
Trillium Health Partners - Credit Valley Hospital
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MississaugaCanadaUnknown status
The Moncton Hospital
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MonctonCanadaUnknown status
Stronach Regional Health Centre at Southlake
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NewmarketCanadaUnknown status
Ottawa Hospital Research Institute
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OttawaCanadaUnknown status
Allan Blair Cancer Centre
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ReginaCanadaUnknown status
Regional Health Authority B, Zone 2
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Saint JohnCanadaUnknown status
Saskatoon Cancer Centre
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SaskatoonCanadaUnknown status
Niagara Health System
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St. CatharinesCanadaUnknown status
Sinai Health System
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TorontoCanadaUnknown status
Odette Cancer Centre
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TorontoCanadaUnknown status
Toronto Rehab
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TorontoCanadaUnknown status
BCCA - Vancouver Cancer Centre
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VancouverCanadaUnknown status
CancerCare Manitoba
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WinnipegCanadaUnknown status
-
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MontpellierFranceUnknown status
Belfast City Hospital
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BelfastUnited KingdomUnknown status
Exercise Medicine Center for Diabetes and Cancer
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SeoulSouth KoreaUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Dartmouth Hitchcock
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LebanonUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.