Trial Information

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

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.