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

September 29, 2005
October 4, 2010
July 2005
November 2009   (final data collection date for primary outcome measure)
Minutes of moderate-intensity physical activity (PA) at 3 months among 134 sedentary patients who have completed treatment for colorectal cancer (CRC).
Same as current
Complete list of historical versions of study NCT00230646 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
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Promoting Physical Activity After Colorectal Cancer
Promoting Physical Activity After Colorectal Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Colon Cancer
  • Rectal Cancer
Behavioral: Exercise counseling
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
November 2009
November 2009   (final data collection date for primary outcome measure)

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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Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230646
CA101770
Not Provided
Not Provided
The Miriam Hospital
Not Provided
Principal Investigator: Bernardine M Pinto, Ph.D. The Miriam Hospital
The Miriam Hospital
September 2005

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