Step Down Colon Cancer Risk

Study Overview
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Brief Summary
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Hypothesis 1: Exercise will decrease serum markers in a dose response manner. Hypothesis 2: Participants in the 60 minute intervention will have significantly higher physical activity levels than those in the 30 minute intervention at three months.

Detailed Description
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Primary Aim: To conduct a dose response pilot trial of low (30 min/day) or high (60 min/day) dose exercise in men and women at increased risk of colon cancer. The major outcomes are changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2. Secondary Aim. To compare changes in the secondary outcome of physical activity over three months.

Official Title
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Step Down Colon Cancer Risk: A Pilot Intervention for Colon Cancer Risk Reduction

Conditions
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Adenomatous Polyps

Intervention / Treatment
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* Behavioral: Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 50 to 80 no personal cancer history found to have an adenomatous polyp upon colonoscopy at BJH/WUSM in the previous six months no contraindications to beginning an exercise program no previous diagnosis of familial polyposis syndromes no previous diagnosis of ulcerative colitis or Crohn's disease; Exclusion Criteria: Participants who are regular NSAID users will be excluded as this may interfere with the measurement of inflammatory marker outcomes. Regular use is defined as taking 80mg or more per day of aspirin, ibuprofen, naproxen or other NSAID 5 or more days of the week.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: 30 minutes walking<br>First Step program with 30 minutes of walking and 10,000 steps per day for 3 months. | Behavioral: Walking<br>* 7 days prior to baseline participants must wear a blinded pedometer At baseline information on the blinded pedometer will downloaded to the computer for analysis as well as number of days worn and hours of wear. Sociodemographic, cancer risk factors, height/weight, fast blood draw to check levels on insulin, C-peptide, IL-6 and PEG-2 and questionnaires PPAQ, Exercise Confident Survey and Sallis Social Support Scale, Day/night; Home/Work, neighborhood safety, HINTS, IPAPS, CES-D, Brief COPE, Urban and Life Stress Scale.<br>|
| Experimental: Arm B: 60 minutes walking<br>First Step program with 60 minutes of walking and 13,000 steps per day for 3 months. | Behavioral: Walking<br>* 7 days prior to baseline participants must wear a blinded pedometer At baseline information on the blinded pedometer will downloaded to the computer for analysis as well as number of days worn and hours of wear. Sociodemographic, cancer risk factors, height/weight, fast blood draw to check levels on insulin, C-peptide, IL-6 and PEG-2 and questionnaires PPAQ, Exercise Confident Survey and Sallis Social Support Scale, Day/night; Home/Work, neighborhood safety, HINTS, IPAPS, CES-D, Brief COPE, Urban and Life Stress Scale.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise will decrease serum markers (insulin, C-peptide, IL-6 and PGE-2) in a dose response manner. | Changes in serum levels of four risk-related biomarkers: insulin, C-peptide, IL-6 and PGE-2 comparing baseline and 3 months serum levels. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants in the 60 minute intervention will have significantly higher physical activity levels (measured by pedometer and accelerometer) than those in the 30 minute intervention at three months. | Comparing changes in the secondary outcome of physical activity over three months, as measured by pedometer and accelerometer. | 3 months |