Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

Colorectal Cancer (CRC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977613
• Other study ID #: 003-07
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: March 1, 2011
• Start date: April 2007
• Est. completion date: May 2010

Study information

• Verified date: March 2011
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

• Colorectal Cancer (CRC)
• Colorectal Neoplasms

Intervention

Behavioral:
• exercise counseling
motivational counseling to exercise a minimum 18 metabolic hours per week

Locations

Country	Name	City	State
United States	Beth Israel Medical Center - Philipps Ambulatory Care Center	New York	New York
United States	St. Luke's Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater	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	No
Secondary	Disease-free Survival		after 6 months	No
Secondary	Recurrence-free Survival		after 6 months	No
Secondary	Overall Survival		after 6 months	No