Testing the Effects of Exercise on Colorectal Cancer Development After Treatment With Pelvic Radiation Therapy for Prostate Cancer

PRIMARY OBJECTIVE:

I. Determine the effects of exercise on mitigating molecular features in collected normal mucosa sample and any polyps identified.

SECONDARY OBJECTIVES:

I. Study longitudinal changes in predictors of colon cancer risk. II. Evaluate accrual and retention rates, as well as exercise compliance and safety.

EXPLORATORY OBJECTIVE:

I. Bank tissue from standard of care colonoscopies/flex sigmoidoscopies for exploratory biological analyses (e.g., immune cell infiltration, mutational signature analysis).

OUTLINE:

STAGE 1: Patients undergo standard of care (SOC) colonoscopy/flex sigmoidoscopy with tissue biopsy, have their Apple Health physical activity data collected and analyzed, and complete a survey. Patients determined to have low physical activity over the previous 12 months may proceed to Stage 2.

STAGE 2: Patients participate in individualized walking sessions over 10-70 minutes each, 5 times per week (225 minutes total per week), for 6 months. Patients also undergo collection of a blood sample on study and undergo SOC colonoscopy/flex sigmoidoscopy with tissue biopsy during follow-up.

After completion of study intervention, patients are followed up within 2 weeks, or up to 3 months, for completion of follow-up SOC colonoscopy/flex sigmoidoscopy.

Inclusion criteria

• Documented informed consent of the participant and/or legally authorized representative

• Assent, when appropriate, will be obtained per institutional guidelines
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies

• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Age: 40-80 years
• Body mass index (BMI): > 25 kg/m^2
• Has Apple Health application (app) on personal device with valid iOS operating software (i.e., iOS 15.0 or higher)
• Has a registered MyChart/MyCityofHope account (or be willing to register for one) and the app downloaded onto personal device
• Ability to read and understand English to review MyChart/MyCityofHope on-screen instructions to sync and share Apple Health data, and for safety during exercise testing
• Previously diagnosed with localized prostate cancer
• Completed pelvic radiotherapy 12-20 months ago
• Presence of abnormalities (e.g., polyps, lesions) in the colon
• Assessed for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (stage 2 only)
• Low physical activity, defined by < 5,000 steps/day over the last 12 months as per Apple Health data (stage 2 only)

Exclusion criteria

• Enrollment in any other program (e.g., weight loss program) that may alter the impact of exercise on outcomes
• Presence of any other concurrent, actively treated malignancy
• Distant metastatic malignancy of any kind
• Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)