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Spots Global Cancer Trial Database for Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer

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Trial Identification

Brief Title: Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer

Official Title: The Effect of Moderate Physical Activity on the Physical and Emotional Recovery of Patients With a History of Colorectal Cancer

Study ID: NCT00373022

Study Description

Brief Summary: RATIONALE: Physical activity may prevent or lessen depression and anxiety and improve quality of life and immune function in patients with colorectal cancer. PURPOSE: This randomized clinical trial is studying how well physical activity helps patients with stage II or stage III colorectal cancer recover from cancer.

Detailed Description: OBJECTIVES: Primary * Assess the effect of moderate physical activity interventions in ameliorating quality of life (as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire) in patients undergoing or who have previously received chemotherapy for stage II or III colorectal cancer. Secondary * Assess the effect of different moderate physical activity interventions in ameliorating depression (as measured by the Beck Depression Inventory) and anxiety (as measured by the Spielberger State-Trait Anxiety Inventory) in these patients. * Assess the effect of these interventions on attitudes related to physical activity (as measured by the American Council on Exercise History questionnaire) in these patients. * Characterize serum levels and patterns of immune function (cytokines, neutrophils, T cells, B cells, natural killer \[NK\] cells, and immunoglobulin) in these patients. * Correlate serum levels and patterns of immune function (cytokines, neutrophils, T cells, B cells, NK cells, and immunoglobulin) with the patients' physical activity levels. OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients participate in individual walking sessions once a week for 8 weeks. The sessions include a fitness-related discussion, warm-up and stretch, 45 minutes of physical activity consisting of walking (progressing in intensity), and a cool-down period. * Arm II: Patients participate in a group walking sessions once a week for 8 weeks. The sessions include a fitness-related discussion, warm-up and stretch, 45 minutes of physical activity consisting of walking (progressing in intensity as in arm I), and a cool-down period. * Arm III: Patients participate in self-directed physical activity sessions (1½ hours) once a week for 8 weeks. The sessions include warm-up and stretch followed by 45 minutes of progressively intensified physical activity that integrates fundamentals of movement, dance, and exercise principles from established movement methods (i.e., yoga) and a relaxation session/cool-down period. All patients complete self-reported questionnaires (Spielberger State-Trait Anxiety Inventory, Beck Depression Inventory, Functional Assessment of Cancer Therapy-Colon, and American Council on Exercise History questionnaires). Patients also undergo blood collection at baseline, at 4 weeks, upon completion of study treatment, and at 4 months after completion of study treatment for correlative studies. Blood is examined by flow cytometry for immune function and cytokines. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States

Contact Details

Name: Ana Maria Lopez, MD, MPH

Affiliation: University of Arizona

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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