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
- Diseases
- Colorectal cancer
- 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
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Armidale Hospital Coordinator of this site? Confirm its status | Armidale | Australia | Unknown status |
| Bankstown-Lidcombe Hospital Coordinator of this site? Confirm its status | Bankstown | Australia | Unknown status |
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Macarthur Cancer Therapy Centre - Campbelltown Hospital Coordinator of this site? Confirm its status | Campbelltown | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| North Coast Cancer Institute Coffs Harbour Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Unknown status |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Newcastle Private Hospital Coordinator of this site? Confirm its status | Newcastle | Australia | Unknown status |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| North Coast Cancer Institute - Port Macquarie Coordinator of this site? Confirm its status | Port Macquarie | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Tamworth Hospital Coordinator of this site? Confirm its status | Tamworth | Australia | Unknown status |
| Riverina Cancer Care Centre Coordinator of this site? Confirm its status | Wagga Wagga | Australia | Unknown status |
| Sydney Adventist Hospital Coordinator of this site? Confirm its status | Wahroonga | Australia | Unknown status |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville | Australia | Unknown status |
| Princess Alexandra Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Tom Baker Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Horizon Health Network Coordinator of this site? Confirm its status | Fredericton | Canada | Unknown status |
| Juravinski Cancer Centre at Hamilton Health Sciences Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Kingston Health Sciences Centre Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Grand River Regional Cancer Centre Coordinator of this site? Confirm its status | Kitchener | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Lévis | Canada | Unknown status |
| London Regional Cancer Program Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Trillium Health Partners - Credit Valley Hospital Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| The Moncton Hospital Coordinator of this site? Confirm its status | Moncton | Canada | Unknown status |
| Stronach Regional Health Centre at Southlake Coordinator of this site? Confirm its status | Newmarket | Canada | Unknown status |
| Ottawa Hospital Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Allan Blair Cancer Centre Coordinator of this site? Confirm its status | Regina | Canada | Unknown status |
| Regional Health Authority B, Zone 2 Coordinator of this site? Confirm its status | Saint John | Canada | Unknown status |
| Saskatoon Cancer Centre Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| Niagara Health System Coordinator of this site? Confirm its status | St. Catharines | Canada | Unknown status |
| Sinai Health System Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Toronto Rehab Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BCCA - Vancouver Cancer Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Exercise Medicine Center for Diabetes and Cancer Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Dartmouth Hitchcock Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
Related publications
- Effects of a structured exercise program on motivational outcomes in patients with colon cancer.J Natl Cancer Inst · 2026 · PMID 41609410
This page is information, not medical advice. Discuss any trial with your doctor.