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Promoting Physical Activity After Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00230646
First received: September 29, 2005
Last updated: October 4, 2010
Last verified: September 2005
  Purpose

Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. However, the group is relatively understudied and the potential benefits of increased physical activity to their recovery have not been examined. This study focuses on enhancing recovery by offering a home-based physical activity program to patients who have completed treatment for colorectal cancer. This study will test the efficacy of the physical activity intervention using a randomized controlled design among 134 patients who have completed treatment for colorectal cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 (posttreatment), 6 and 12 months. We will also track intervention costs and conduct exploratory analyses of moderators and mediators of change to help guide the future development of physical activity interventions to enhance recovery from colorectal cancer.


Condition Intervention Phase
Colon Cancer
Rectal Cancer
Behavioral: Exercise counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Promoting Physical Activity After Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Minutes of moderate-intensity physical activity (PA) at 3 months among 134 sedentary patients who have completed treatment for colorectal cancer (CRC).

Secondary Outcome Measures:
  • Examine the effects of the intervention on survivors' physical functioning, fitness, vigor, fatigue and body esteem at 3 months.
  • Examine the maintenance of outcomes (minutes of moderate intensity activity, physical functioning, vigor, fatigue and body esteem) at 6 and 12 months.

Enrollment: 46
Study Start Date: July 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors face many physical and psychosocial sequelae including second cancers, adverse effects on major organs, cognitive, and sexual function, problems in work and social roles and reduced quality of life. Following adjuvant treatments (chemotherapy and/or radiation), these individuals may be at increased risk for cardiovascular disease, obesity, osteoporosis and future cancers. There is growing evidence that moderate-intensity physical activity can improve physical functioning, reduce fatigue, enhance vigor and improve body esteem among those treated for breast cancer. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. However, the group is relatively understudied and the potential benefits of increased physical activity to their recovery have not been examined. This study focuses on enhancing recovery by offering a home-based physical activity program to patients who have completed treatment for colorectal cancer. The program, based on our prior work among breast cancer survivors, consists of telephone-delivered physical activity counseling over three months. The counseling is based on the Transtheoretical Model, Social Cognitive Theory and elements of Motivational Interviewing. This study will test the efficacy of the physical activity intervention using a randomized controlled design among 134 patients who have completed treatment for colorectal cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 (posttreatment), 6 and 12 months. We will also track intervention costs and conduct exploratory analyses of moderators and mediators of change to help guide the future development of physical activity interventions to enhance recovery from colorectal cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1) men and women aged >18 years, 2) completed primary and adjuvant treatment for colon or rectal cancer (Stages 1-3). To allow for adequate recovery from treatment, patients whose only treatment is surgery, will be eligible for study participation 12 weeks after surgery and remain eligible for 2 years. Patients who have received chemotherapy or radiation will become eligible 8 weeks after treatment completion, and will remain eligible up to 2 years posttreatment. 3) <2 years since treatment completion, 4) able to read and speak English, 5) provide consent for medical chart review, 6) able to walk unassisted, 7) sedentary which will be defined as: currently not exercising for >30 mins. of moderate-intensity activity on >2 days per week or >20 mins. of vigorous activity one or more days per week over the past 6 months, and 8) have access to a telephone.

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Exclusion Criteria:Diabetes, hyperlipidemia and uncontrolled hypertension. Patients who have a positive cardiac history (myocardial infarction, angina, peripheral vascular disease, claudication, transient ischemic attacks, claudication, and past history of stroke) will be asked to obtain written permission from their cardiologist prior to study enrollment.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230646

Locations
United States, Rhode Island
Centers for Behavioral and Preventive Medicine
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Bernardine M Pinto, Ph.D. The Miriam Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00230646     History of Changes
Other Study ID Numbers: CA101770
Study First Received: September 29, 2005
Last Updated: October 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
cancer recovery
physical activity

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

ClinicalTrials.gov processed this record on November 20, 2014