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

September 15, 2009
March 1, 2011
April 2007
April 2010   (final data collection date for primary outcome measure)
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.
compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00977613 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Colorectal Cancer (CRC)
Behavioral: exercise counseling
motivational counseling to exercise a minimum 18 metabolic hours per week
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.
Intervention: Behavioral: exercise counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2010
April 2010   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00977613
003-07
No
Peter Kozuch, MD, Beth Israel Medical Center
Beth Israel Medical Center
Not Provided
Principal Investigator: Peter S Kozuch, MD Beth Israel Medical Center
Beth Israel Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP