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Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: September 6, 2006   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: University of Arizona
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00373022
  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
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

MedlinePlus related topics: Anxiety Cancer Colorectal Cancer Depression Exercise and Physical Fitness
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • 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
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373022

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
Investigators
Study Chair: Ana Maria Lopez, MD, MPH University of Arizona
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
depression
anxiety disorder
psychosocial effects/treatment
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009