Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

March 1, 2011 updated by: Beth Israel Medical Center

Prospective Evaluation of Adherence to Recommended Activity Regimen in Patients Following Treatment of Stages II and III Colorectal Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • St. Luke's Roosevelt Hospital Center
      • New York, New York, United States, 10003
        • Beth Israel Medical Center - Philipps Ambulatory Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: life style 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.
Behavioral: exercise counseling
motivational counseling to exercise a minimum 18 metabolic hours per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free Survival
Time Frame: after 6 months
after 6 months
Recurrence-free Survival
Time Frame: after 6 months
after 6 months
Overall Survival
Time Frame: after 6 months
after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Medical Center

Investigators

  • Principal Investigator: Peter S Kozuch, MD, Beth Israel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 3, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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