Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer
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Purpose
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 |
|---|---|
|
Anxiety Disorder Colorectal Cancer Depression Psychosocial Effects of Cancer and Its Treatment |
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: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | The Effect of Moderate Physical Activity on the Physical and Emotional Recovery of Patients With a History of Colorectal Cancer |
- Effect of moderate physical activity on quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire
- Effect of moderate physical activity on depression and anxiety as measured by the Beck Depression Inventory and the Spielberger State-Trait Anxiety Inventory
- Effect of moderate physical activity on attitudes related to physical activity as measured by the American Council on Exercise History questionnaire
- Serum levels and patterns of immune function as measured by cytokine, neutrophil, T cell, B cell, natural killer (NK) cell, and immunoglobulin levels
- Correlation of serum levels and patterns of immune function (cytokine, neutrophil, T cell, B cell, NK cell, and immunoglobulin levels) with physical activity levels
| Estimated Enrollment: | 45 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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| 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:
- 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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ana Maria Lopez, MD, Arizona Cancer Center at University of Arizona Health Science Center |
| ClinicalTrials.gov Identifier: | NCT00373022 History of Changes |
| Other Study ID Numbers: | CDR0000491199, P30CA023074, UARIZ-A04.04 |
| Study First Received: | September 6, 2006 |
| Last Updated: | May 26, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Arizona:
|
depression anxiety disorder psychosocial effects of cancer and its treatment stage II colon cancer |
stage III colon cancer stage II rectal cancer stage III rectal cancer |
Additional relevant MeSH terms:
|
Anxiety Disorders Colorectal Neoplasms Depression Depressive Disorder Mental Disorders Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 23, 2013