Health Education Materials Patients with Colon Cancer
common.study.values.description
“Health Education Materials With or Without a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer”
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.
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Behavioral - 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 an ...read more on ClinicalTrials.org
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
Procedure - fatigue assessment and management
Every 6 months
Procedure - 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
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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 (CHALLENGE)
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NCT00819208
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