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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00373022 |
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.
Condition | Intervention |
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Cancer-Related Problem/Condition Colorectal Cancer |
Behavioral: exercise intervention Other: flow cytometry Other: laboratory biomarker analysis Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized |
Official Title: | The Effect of Moderate Physical Activity on the Physical and Emotional Recovery of Patients With a History of Colorectal Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage II-III colorectal cancer meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | |
Tucson, Arizona, United States, 85724-5024 |
Study Chair: | Ana Maria Lopez, MD, MPH | University of Arizona |
Study ID Numbers: | CDR0000491199, UARIZ-A04.04 |
Study First Received: | September 6, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00373022 History of Changes |
Health Authority: | United States: Federal Government |
depression anxiety disorder psychosocial effects/treatment stage II colon cancer |
stage III colon cancer stage II rectal cancer stage III rectal cancer |
Depression Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Depressive Disorder Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Rectal Cancer Digestive System Diseases Anxiety Disorders Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |