Viewing Study NCT00230646



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00230646
Status: COMPLETED
Last Update Posted: 2010-10-05
First Post: 2005-09-29

Brief Title: Promoting Physical Activity After Colorectal Cancer
Sponsor: The Miriam Hospital
Organization: The Miriam Hospital

Study Overview

Official Title: Promoting Physical Activity After Colorectal Cancer
Status: COMPLETED
Status Verified Date: 2005-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Colorectal cancer is the third most common cancer in the US 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
Detailed Description: Colorectal cancer is the third most common cancer in the US 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None