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

Not Applicable

Completed

• Conditions: Rectal Cancer; Patient Activation; Low Anterior Resection; Surgery; Low Anterior Resection Syndrome
• Interventions: Other: Patient Activation Booklet and nursing support for patients with LARS

• Registration Number: NCT03828318
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Start: 2019-09-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Activation Arm	Patient Activation Booklet and nursing support for patients with LARS	-

Primary Outcome Measures

Name	Time	Method
Global quality of life (QoL)	12 months	Measured by EORTC QLQ-C30

Trial Locations

Locations (6)

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; 🇨🇦 Montréal, Quebec, Canada

CHU de Quebec; 🇨🇦 Québec, Quebec, Canada