Promoting Physical Activity After Colorectal Cancer

NCT ID: NCT00230646

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colon Cancer Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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Exercise counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Bernardine M Pinto, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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Centers for Behavioral and Preventive Medicine

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Kindred MM, Pinto BM, Dunsiger SI. Association of Body Esteem with Fitness and Body Fat Among Colorectal Cancer Survivors: Secondary Analyses from a Randomized Trial. Int J Behav Med. 2019 Dec;26(6):619-628. doi: 10.1007/s12529-019-09819-x.

Reference Type DERIVED
PMID: 31650480 (View on PubMed)

Other Identifiers

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CA101770

Identifier Type: -

Identifier Source: org_study_id