Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

Not Applicable

Completed

• Conditions: Colorectal Cancer (CRC)
• Interventions: Behavioral: exercise counseling

• Registration Number: NCT00977613
• Lead Sponsor: Beth Israel Medical Center

Brief Summary

Given the apparent effect of 18 metabolic equivalent task-hours of activity/week in improving disease free survival in patients with treated stage 3 colon cancer and the survival benefit of exercise demonstrated in patients with stage II and III colorectal cancer, the primary objective is to evaluate compliance at 6 months with post-treatment recommendations for a minimum of 18 metabolic units of physical activity each week in patients who have completed therapy for stage 2 and stage 3 colorectal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Results First Submitted: 2010-11-30
• Results First Submitted QC: 2011-02-24
• Results First Posted: 2011-02-28
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients with histological confirmation of stage 2 or stage 3 colorectal cancer.
2. Ability to sign written informed consent.
3. WHO performance status of 2 or better.
4. No evidence of recurrent disease or death prior to second questionnaire.
5. Patients with declining physical activity within 90 days of second physical activity assessment will be excluded.

There are no exclusion criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
life style counseling	exercise counseling	Treated stage 2 and 3 colorectal cancer patients were counseled to exercise at least to the equivalent of 18 metabolic hours per week and were assessed over 6 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater	6 months	One MET is the energy expenditure for sitting quietly for 1 hour. MET scores for walking were assigned based on the pace and duration reported. For other activities, a leisurely to moderate intensity score was selected. The scores for MET-hours per week for each activity were calculated from the reported hours per week engaged in that activity multiplied by the assigned MET score, and individual activities were summed to derive a total MET-hours per week.

Secondary Outcome Measures

Name	Time	Method
Recurrence-free Survival	after 6 months
Overall Survival	after 6 months
Disease-free Survival	after 6 months

Trial Locations

Locations (2)

Beth Israel Medical Center - Philipps Ambulatory Care Center; 🇺🇸 New York, New York, United States

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States