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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373022
• Other study ID #: CDR0000491199
• Secondary ID: P30CA023074UARIZ
• Status: Completed
• Phase: N/A
• First received: September 6, 2006
• Last updated: May 26, 2010
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2006
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Colorectal Cancer
• Colorectal Neoplasms
• Depression
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Behavioral:
• exercise intervention

Other:
• flow cytometry

• laboratory biomarker analysis

Procedure:
• management of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of moderate physical activity on quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire
Secondary	Effect of moderate physical activity on depression and anxiety as measured by the Beck Depression Inventory and the Spielberger State-Trait Anxiety Inventory
Secondary	Effect of moderate physical activity on attitudes related to physical activity as measured by the American Council on Exercise History questionnaire
Secondary	Serum levels and patterns of immune function as measured by cytokine, neutrophil, T cell, B cell, natural killer (NK) cell, and immunoglobulin levels
Secondary	Correlation of serum levels and patterns of immune function (cytokine, neutrophil, T cell, B cell, NK cell, and immunoglobulin levels) with physical activity levels