Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Canadian Cancer Trials Group
Collaborating Sponsors:
Survivorship Research Group
Queen's University, Belfast
Conditions:
Anxiety Disorder
Cognitive/Functional Effects
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
Detailed Description
OBJECTIVES: 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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2030
Estimated Enrollment :
889 Patients enrolled
Trial Details
Trial ID
NCT00819208
Start Date
June 2 2009
End Date
December 15 2030
Last Update
September 16 2025
Active Locations (47)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States, 03756
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-1651
4
Armidale Hospital
Armidale, New South Wales, Australia, 2350