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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Cancer, Surgery, Patient Activation, Low Anterior Resection, Low Anterior Resection Syndrome

Intervention / Treatment
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* Other: Patient Activation Booklet and nursing support for patients with LARS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Activation Arm<br> | Other: Patient Activation Booklet and nursing support for patients with LARS<br>* The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.<br>|
| No Intervention: Standard Care Arm<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global quality of life (QoL) | Measured by EORTC QLQ-C30 | 12 months |