Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer
NCT ID: NCT00373022
Last Updated: 2010-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2004-01-31
2006-12-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well physical activity helps patients with stage II or stage III colorectal cancer recover from cancer.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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exercise intervention
flow cytometry
laboratory biomarker analysis
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of stage II-III colorectal cancer meeting 1 of the following criteria:
* Undergoing concurrent chemotherapy
* Completed chemotherapy within the past 2 years
PATIENT CHARACTERISTICS:
* No physical or emotional impairment that would limit study compliance
* No prior or current chronic substance abuse
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Arizona
OTHER
Responsible Party
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Arizona Cancer Center at University of Arizona Health Science Center
Principal Investigators
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Ana Maria Lopez, MD, MPH
Role: STUDY_CHAIR
University of Arizona
Locations
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Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Countries
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Other Identifiers
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UARIZ-A04.04
Identifier Type: -
Identifier Source: secondary_id
CDR0000491199
Identifier Type: -
Identifier Source: org_study_id
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