Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

NCT00977613 | Completed Results

• 1 other identifier: 003-07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer (CRC)

Keywords

Treated Stage 2 and Stage 3 colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Disease-free Survival

  after 6 months

• Recurrence-free Survival

  after 6 months

• Overall Survival

  after 6 months

Study Arms (1)

life style counseling

OTHER

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

Interventions

exercise counseling BEHAVIORAL

motivational counseling to exercise a minimum 18 metabolic hours per week

life style counseling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histological confirmation of stage 2 or stage 3 colorectal cancer.
• Ability to sign written informed consent.
• WHO performance status of 2 or better.
• No evidence of recurrent disease or death prior to second questionnaire.
• Patients with declining physical activity within 90 days of second physical activity assessment will be excluded.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (2)

Beth Israel Medical Center - Philipps Ambulatory Care Center

New York, New York, 10003, United States

Location

St. Luke's Roosevelt Hospital Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

Many participants were lost to follow-up. Some participants had not been followed for at least 6 months at study termination.

Results Point of Contact

• Title: Victoria Rosenwald
• Organization: Beth Israel Cancer Center

vrosenwa@chpnet.org

212 844-8285

Study Officials

• Peter S Kozuch, MD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: April 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 3, 2011
• Results First Posted: February 28, 2011

Record last verified: 2011-03

Locations

US (2)