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

• Sponsor: Jewish General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03828318
• Collaborator: Providence Healthcare (Other), McGill University Health Centre/Research Institute of the McGill University Health Centre (Other), Centre Hospitalier du Quebec (Other), University of Manitoba (Other)
• Enrollment: 128
• Locations: 6
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site: 21.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2019
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Global quality of life (QoL) [12 months]

   Measured by EORTC QLQ-C30

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Providence Healthcare	Vancouver	British Columbia	Canada
3	University of Manitoba	Winnipeg	Manitoba	Canada
4	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
5	McGill University Health Centre	Montréal	Quebec	Canada
6	CHU de Quebec	Québec	Quebec	Canada

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Marylise Boutros, Colorectal Surgeon, Jewish General Hospital
• ClinicalTrials.gov Identifier: NCT03828318
• Other Study ID Numbers: MP-05-2019-1628
• First Posted: Feb 4, 2019
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Syndrome

Study Results

No Results Posted as of Aug 18, 2022