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

NCT00373022 | Completed

• 3 other identifiers: CDR0000491199P30CA023074UARIZ-A04.04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Colorectal Cancer; Depression; Psychosocial Effects of Cancer and Its Treatment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effect of moderate physical activity on quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire

Secondary Outcomes (4)

• 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

Interventions

exercise intervention BEHAVIORAL

flow cytometry OTHER

laboratory biomarker analysis OTHER

management of therapy complications PROCEDURE

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Colorectal Neoplasms; Depression; Colonic Neoplasms; Rectal Neoplasms

Interventions

Flow Cytometry; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

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; Behavior

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ana Maria Lopez, MD, MPH

  University of Arizona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 7, 2006
• Study Start: January 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 27, 2010

Record last verified: 2006-12

Locations

US (1)