N/A
N=889
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
Anxiety Disorder · Cognitive/Functional Effects · Colorectal Cancer · Depression · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT00819208 ↗Enrolled (actual)
889
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Disease-free Survival — 80.3; 73.9 percentage of participants — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- exercise intervention (Behavioral); counseling intervention (Other); educational intervention (Other); laboratory biomarker analysis (Other); questionnaire administration (Other); study of socioeconomic and demographic variables (Other); fatigue assessment and management (Procedure); quality-of-life assessment (Procedure); Fitness testing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Canadian Cancer Trials Group
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival |
80.3; 73.9 | 0.02 sig |
| SECONDARY Overall Survival |
90.3; 83.2 | 0.02 sig |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00819208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.