Promoting Physical Activity After Colorectal Cancer
18 Years
N/A
Both
Colon Cancer, Rectal Cancer
Trial Information
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 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.
Inclusion Criteria:
1) men and women aged >18 years, 2) completed primary and adjuvanttreatment 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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Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Outcome Measure:
Minutes of moderate-intensity physical activity (PA) at 3 months among 134 sedentary patients who have completed treatment for colorectal cancer (CRC).
Principal Investigator
Bernardine M Pinto, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Miriam Hospital
Authority:
United States: Institutional Review Board
Study ID:
CA101770
NCT ID:
NCT00230646
Start Date:
July 2005
Completion Date:
November 2009
Related Keywords:
- Colon Cancer
- Rectal Cancer
- cancer recovery
- physical activity
- Colonic Neoplasms
- Rectal Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Centers for Behavioral and Preventive Medicine | Providence, Rhode Island 02908 |
