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

August 17, 2022 updated by: Dr. Marylise Boutros, Jewish General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • underwent restorative protectomy for Neo-plastic disease of the rectum
  • completed all treatment within the last 3 years
  • patients with minor or major LARS as defined with the LARS score.

Exclusion Criteria:

  • Active chemotherapy or radiotherapy
  • Major colonic resection in addition to protectomy
  • Cannot be contacted by telephone
  • Unable to read and comprehend English/French
  • Does not have the appropriate interface to access the app
  • Unable to give clear and informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Informational online app group
Participants will have access to an interactive online peer support app developed by the research team.
Other: Interactive online informational and peer support app
The app contains LARS information, bowel function diaries, and online platform with trained peer support mentor
No Intervention: Booklet only
Participants will only have access to the educational booklet on LARS developed by the colorectal research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire
Time Frame: 1 week before the launch of the app
Questionnaire measures baseline quality of life before app use. Maximum score 100 (better function, quality of life). Minimum score 0 (worse function, quality of life).
1 week before the launch of the app
Assessing 'Change' via European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire after 6 months
Time Frame: 6 months after using the app.
Questionnaire measures change in quality of life after app use. Maximum score 100 (better function, quality of life). Minimum score 0 (worse function, quality of life).
6 months after using the app.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient activation measures
Time Frame: 1 week before the launch of the app
Questionnaire measures patient activation before app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).
1 week before the launch of the app
Change in Patient activation measures
Time Frame: 6 months after using the app.
Questionnaire measures patient activation after app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).
6 months after using the app.
Bowel function Low Anterior Resection Syndrome score
Time Frame: 1 week before the launch of the app
Questionnaire measures bowel function before app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)
1 week before the launch of the app
Bowel function Low Anterior Resection Syndrome score
Time Frame: 6 months after using the app.
Questionnaire measures bowel function after app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)
6 months after using the app.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish General Hospital

Collaborators

University Health Network, Toronto
McGill University Health Centre/Research Institute of the McGill University Health Centre
Mount Sinai Hospital, Canada
Providence Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Anticipated)

September 15, 2022

Study Completion (Anticipated)

March 15, 2023

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JGH-2020-2073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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