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Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977613
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : February 28, 2011
Last Update Posted : March 3, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer (CRC) Behavioral: exercise counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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.
Study Start Date : April 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Disease-free Survival [ Time Frame: after 6 months ]
  2. Recurrence-free Survival [ Time Frame: after 6 months ]
  3. Overall Survival [ Time Frame: after 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977613

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

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Responsible Party: Peter Kozuch, MD, Beth Israel Medical Center Identifier: NCT00977613     History of Changes
Other Study ID Numbers: 003-07
First Posted: September 16, 2009    Key Record Dates
Results First Posted: February 28, 2011
Last Update Posted: March 3, 2011
Last Verified: March 2011

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

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