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Sponsored by: |
The Miriam Hospital |
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Information provided by: | The Miriam Hospital |
ClinicalTrials.gov Identifier: | NCT00230646 |
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 |
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Colon Cancer Rectal Cancer |
Behavioral: Exercise counseling |
Phase III |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Promoting Physical Activity After Colorectal Cancer |
Estimated Enrollment: | 134 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | October 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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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Contact: Bernardine M Pinto | 401-793-8230 | BPinto@lifespan.org |
United States, Rhode Island | |
Centers for Behavioral and Preventive Medicine | Recruiting |
Providence, Rhode Island, United States, 02908 | |
Contact: Bernardine Pinto, Ph.D. 401-793-8230 BPinto@lifespan.org | |
Contact: Suzanne Moriarty, MSW 401-793-8095 SMoriarty@lifespan.org | |
Principal Investigator: Bernardine M Pinto, Ph.D. |
Principal Investigator: | Bernardine M Pinto, Ph.D. | The Miriam Hospital |
Study ID Numbers: | CA101770 |
Study First Received: | September 29, 2005 |
Last Updated: | September 29, 2005 |
ClinicalTrials.gov Identifier: | NCT00230646 |
Health Authority: | United States: Institutional Review Board |
cancer recovery physical activity |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site |