Interactive Online Informational and Peer Support App for Patients With Low Anterior Resection Syndrome

Patient Satisfaction Clinical Trial

Official title: Interactive Online Informational and Peer Support App for Patients With Low Anterior Resection Syndrome (LARS): A Multicenter Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

After surgery for rectal cancer, many people undergo changes in bowel habits, which may include the need to empty their bowels more often, accidental leakage of stool or gas, the sudden urge to go to the bathroom, and more. The term "Low Anterior Resection Syndrome" or LARS is used to describe these symptoms. LARS has a negative impact on one's quality of life, and can lead to frustration, as there is no single intervention that has proven to be effective for LARS, and each patient has to undergo trial and error to find one's solution. As people struggle with LARS, they describe feeling hopeless and isolated. Peer support is a supportive relationship between individuals who share common experiences or face similar challenges. The goal of our study is to evaluate whether use of an online peer support application with trained mentors who themselves have lived or are living with LARS will empower patients to better manage their LARS symptoms and improve their quality of life.

Clinical Trial Description

Restorative proctectomy is increasingly being performed for rectal cancer, allowing patients to avoid permanent colostomy. Low Anterior Resection Syndrome (LARS) refers to a constellation of bowel symptoms including frequency, urgency, incontinence, and clustering of bowel movements, that can affect up to 70 to 90% of patients following restorative proctectomy. Symptoms can last up to 15 years after resection. Currently, there is no standard treatment for LARS and management is symptom-based and reactive, rather than proactive. A recent focus group conducted at our institution among LARS patients and caregivers showed that people living with LARS experience anxiety and isolation due to their symptoms.

Peer support could be an important psychosocial intervention for people living with LARS, helping them normalize and validate their experience. Peer support refers to a supportive relationship between individuals who share common experiences or face similar challenges. This approach has been associated with positive physical and mental health outcomes for several patient populations. Our research group conducted a comprehensive review of online health information for patients with LARS, and demonstrated that existing online resources were generally of poor quality and lacked important content. With this knowledge, we created a LARS educational booklet and developed an online app containing LARS educational material and an interactive forum for online peer support. We are now in an optimal position to rigorously test the potential effects of this initiative on patient-centered outcomes.

This study is a multicenter, randomized, assessor-blind, parallel-groups, pragmatic trial involving patients from 5 large colorectal surgery practices (Jewish General Hospital, McGill University Health Centre-Montreal, QC; Toronto Western Hospital, Mount Sinai Hospital- Toronto, ON; Saint Paul's Hospital-Vancouver, BC). Participants will be randomized into the intervention group, who will have access to the online peer support app, and the control group who will only receive a LARS patient educational booklet. Trained peer support mentors will moderate discussion in the peer support forum, which will also be monitored daily by expert health care professionals. Data regarding patient demographics, disease and treatment characteristics will be obtained via hospital chart review. The primary outcome will be health- related quality of life at 6 months. Secondary outcomes will be patient activation and bowel function. We hypothesize that availability of this app (consisting of LARS information, a closed forum for discussion among peers and trained peer support mentors) improves health-related quality of life when compared to the comparison group.

Given the significant numbers of patients who suffer from LARS symptoms following restorative proctectomy and the potential chronic nature of their symptoms, this RCT has the potential to contribute important knowledge to support patient-centered care of rectal cancer survivors. The technology addressed in this study (a mobile app for information and online peer support) is readily accessible and can be relatively easily implemented across large range of geographic jurisdictions and surgical settings. ;

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Health Attitude
• Health Knowledge, Attitudes, Practice
• Low Anterior Resection Syndrome
• Patient Empowerment
• Patient Satisfaction
• Peer Group
• Syndrome

• NCT number: NCT04469426
• Study type: Interventional
• Source: Jewish General Hospital
• Contact: Jeongyoon Moon, MD
• Phone: 5145676370
• Email: jeongyoon.moon@mail.mcgill.ca
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2020
• Completion date: March 15, 2023