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.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III), participating center, body mass index ( 27.5 vs > 27.5), and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment interventions.
Patients complete the Total Physical Activity Questionnaire (TPAQ) to assess exercise participation and undergo fitness testing periodically by the submaximal exercise test and Seniors' Fitness Test (SFT).
Patients complete the SF-36, FACT-F, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Social Cognitive Determinants of Exercise Measure questionnaires periodically. Patients also complete a 30-day resource use diary and undergo a health economics analysis by the Work Productivity and Activity Impairment (WPAI) questionnaire.
Blood samples are collected periodically for correlative studies and fasting glucose. Samples are analyzed for markers of insulin level, IGF-1, IGF-2, and IGFBP3, cytokine levels (i.e., IL-1, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-, IFN-, and GM-CSF), and C-reactive protein levels.
During the 3 year intervention period, patients are followed every 6 months for 3 years and then annually for 4-10 years.
|Treatment||laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, educational intervention, counseling intervention, exercise intervention, fatigue assessment and management, study of socioeconomic and demographic variables, Fitness testing|
|Clinical Study Identifier||NCT00819208|
|Sponsor||Canadian Cancer Trials Group|
|Last Modified on||16 November 2020|
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