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Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00977613
First received: September 15, 2009
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer (CRC)
 Behavioral: exercise counseling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: Prospective Evaluation of Adherence to Recommended Activity Regimen in Patients Following Treatment of Stages II and III Colorectal Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Disease-free Survival [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • Recurrence-free Survival [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: after 6 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977613

Locations
United States, New York
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, United States, 10003
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Peter S Kozuch, MD Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Peter Kozuch, MD, Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00977613     History of Changes
Other Study ID Numbers: 003-07
Study First Received: September 15, 2009
Results First Received: November 30, 2010
Last Updated: March 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
Treated Stage 2 and Stage 3 colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 21, 2013