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Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828318
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
Providence Healthcare
McGill University Health Centre/Research Institute of the McGill University Health Centre
Centre Hospitalier du Quebec
University of Manitoba
Information provided by (Responsible Party):
Dr. Marylise Boutros, Jewish General Hospital

Brief Summary:

After undergoing restorative proctectomy for rectal cancer, many patients are left with significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased LARS severity correlates with worse perceived global health status and quality of life (QoL). Among patients undergoing rectal resection with a permanent ostomy, there is evidence that supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and knowledge. However, evidence regarding the impact of such interventions in patients who undergo restorative proctectomy is lacking, despite the latter operation being far more frequently performed.

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Surgery Patient Activation Low Anterior Resection Low Anterior Resection Syndrome Other: Patient Activation Booklet and nursing support for patients with LARS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Patient Activation Arm Other: 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.

No Intervention: Standard Care Arm



Primary Outcome Measures :
  1. Global quality of life (QoL) [ Time Frame: 12 months ]
    Measured by EORTC QLQ-C30



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (>=18 years-old) 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

Exclusion Criteria:

  • Patients from whom clear and informed consent cannot be obtained
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828318


Contacts
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Contact: Aashiyan Singh, Msc(A) 514-340-8222 ext 25996 aashiyan.singh@ladydavis.ca
Contact: Marie Demian, Msc 514-340-8222 ext 25996 mdemian@jgh.mcgill.ca

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Caitlin Stafford       CSTAFFORD2@partners.org   
Principal Investigator: Liliana Bordeianou         
Canada, British Columbia
Providence Healthcare Recruiting
Vancouver, British Columbia, Canada
Contact: Willis Cao       wcao1@providencehealth.bc.ca   
Principal Investigator: Carl Brown         
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Sarah Sabboobeh         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Marylise Boutros, MD, MSc, FRCSC, FACS. FABCRS    514-340-8222 ext 6821    maryliseboutros@gmail.com   
McGill University Health Centre Recruiting
Montréal, Quebec, Canada
Contact: Sarah Sabboobeh       sarah.sabboobeh@ladydavis.ca   
Principal Investigator: Sender Liberman         
CHU de Quebec Recruiting
Québec, Quebec, Canada
Contact: Ann Wright       ann.wright@chudequebec.ca   
Principal Investigator: Sebastien Drolet         
Sponsors and Collaborators
Jewish General Hospital
Providence Healthcare
McGill University Health Centre/Research Institute of the McGill University Health Centre
Centre Hospitalier du Quebec
University of Manitoba
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Marylise Boutros, Colorectal Surgeon, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03828318    
Other Study ID Numbers: MP-05-2019-1628
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes