GMCB Exercise Intervention in Maintaining Physical Activity in Stage II-IV Colon or Rectal Cancer Survivors

Status: administratively complete

This phase III trial studies how well a group mediated cognitive-behavioral (GMCB) exercise intervention works in maintaining physical activity in stage II-IV colon or rectal cancer survivors. Participating in GMCB exercise sessions may increase aerobic and muscular fitness, increase energy, improve mood, and improve quality of life in colon or rectal cancer survivors. Patients may further benefit from the social support received from the group and may also gain benefits of sustained physical activity, which include reduced risk of cardiovascular disease, colorectal cancer recurrence, and mortality.

Inclusion Criteria

Provision to sign and date the consent form
Have access to a computer or phone with internet and a camera
Fluent in English
Stated willingness to comply with all study procedures and be available for the duration of the study
Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
Completed resection or other surgery 3-60 months prior to enrollment
Received chemotherapy and/or radiation therapy within the previous 5 years, with at least 1 cycle of intended chemotherapy completed (does not need to complete all cycles). No plans for additional chemotherapy or radiation therapy

Exclusion Criteria

Current evidence of metastatic disease
Existing participation in >= 150 minutes per week of at least moderate intensity PA
Known contraindications for exercise or not able to safely participate in exercise
Pregnant women (no testing required)

PRIMARY OBJECTIVE:

I. Compare the effects of a 12-week virtually delivered GMCB exercise intervention versus (vs.) an exercise control group on physical activity (PA) maintenance in colorectal cancer survivors, and explore multi-level determinants of PA maintenance, 6-months after intervention completion.

SECONDARY OBJECTIVE:

I. Compare changes in physical activity, physical fitness, sleep quality, body composition, and quality of life (QOL) between a 12-week GMCB exercise interventions vs. a control group.

TERTIARY/EXPLORATORY OBJECTIVE:

I. Bank blood to examine how changes in light activity and sedentary time following a 12-week exercise intervention influence biomarkers of colorectal cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in group mediated cognitive-behavioral exercise sessions twice weekly over 1 hour each for 12 weeks. Patients also attend group discussion sessions over 30-60 minutes at 1, 4, 7, 9, and 12 weeks following an exercise session.

ARM II: Patients participate in individually supervised exercise sessions twice weekly over 1 hour each for 12 weeks. Patients also attend discussion sessions over 30-60 minutes at 1, 4, 7, 9, and 12 weeks following an exercise session.

After completion of study, patients are followed up to 12 months.

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GMCB Exercise Intervention in Maintaining Physical Activity in Stage II-IV Colon or Rectal Cancer Survivors

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