Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial
NCT ID: NCT03828318
Last Updated: 2024-11-29
Study Results
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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COMPLETED
NA
160 participants
INTERVENTIONAL
2019-09-01
2024-01-31
Brief Summary
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The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy for rectal cancer.
This is a randomized-controlled muticenter trial that will include patients who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Patient Activation Arm
Patient Activation Booklet and nursing support for patients with LARS
The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.
Standard Care Arm
No interventions assigned to this group
Interventions
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Patient Activation Booklet and nursing support for patients with LARS
The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unable to read and comprehend English or French
* Patients who cannot be contacted by telephone
* Patients who have undergone major colonic resection in addition to their proctectomy
* Patients on active chemotherapy or radiotherapy treatment
18 Years
99 Years
ALL
No
Sponsors
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Providence Healthcare
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Centre Hospitalier du Quebec
UNKNOWN
University of Manitoba
OTHER
Jewish General Hospital
OTHER
Responsible Party
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Dr. Marylise Boutros
Colorectal Surgeon
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Providence Healthcare
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Quebec
Québec, Quebec, Canada
Countries
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References
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Garfinkle R, Loiselle CG, Park J, Fiore JF Jr, Bordeianou LG, Liberman AS, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Bhatnagar SR, Boutros M. Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial. BMJ Open. 2020 May 30;10(5):e035587. doi: 10.1136/bmjopen-2019-035587.
Other Identifiers
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MP-05-2019-1628
Identifier Type: -
Identifier Source: org_study_id