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Completed

NCT Number: NCT00977613

Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

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.

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Key information

Conditions

Colorectal Cancer (CRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Medical Center - Philipps Ambulatory Care Center, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

There are no exclusion criteria

Treatment and study plan

Exercise Counseling

Behavioral

motivational counseling to exercise a minimum 18 metabolic hours per week

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2009
Registry last updated
Mar 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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