Promoting Physical Activity After Colorectal Cancer
1 other identifier
interventional
46
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 29, 2005
CompletedFirst Posted
Study publicly available on registry
October 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedOctober 5, 2010
September 1, 2005
4.3 years
September 29, 2005
October 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Minutes of moderate-intensity physical activity (PA) at 3 months among 134 sedentary patients who have completed treatment for colorectal cancer (CRC).
Secondary Outcomes (2)
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.
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centers for Behavioral and Preventive Medicine
Providence, Rhode Island, 02908, United States
Related Publications (1)
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.
PMID: 31650480DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernardine M Pinto, Ph.D.
The Miriam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 29, 2005
First Posted
October 3, 2005
Study Start
July 1, 2005
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
October 5, 2010
Record last verified: 2005-09