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

NCT04469426 | Completed DMC

• 1 other identifier: JGH-2020-2073
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Keywords

colorectal surgery; peer support

Outcome Measures

Primary Outcomes (2)

• European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire

  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

  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 Outcomes (4)

• Patient activation measures

  1 week before the launch of the app

• Change in Patient activation measures

  6 months after using the app.

• Bowel function Low Anterior Resection Syndrome score

  1 week before the launch of the app

• Bowel function Low Anterior Resection Syndrome score

  6 months after using the app.

Study Arms (2)

Informational online app group

EXPERIMENTAL

Participants will have access to an interactive online peer support app developed by the research team.

Other: Interactive online informational and peer support app

Booklet only

NO INTERVENTION

Participants will only have access to the educational booklet on LARS developed by the colorectal research team.

Interventions

Interactive online informational and peer support app OTHER

The app contains LARS information, bowel function diaries, and online platform with trained peer support mentor

Informational online app group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish General Hospital: lead
• Providence Healthcare: collaborator
• Mount Sinai Hospital, Canada: collaborator
• University Health Network, Toronto: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (5)

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Patient Participation; Low Anterior Resection Syndrome; Colonic Neoplasms; Patient Satisfaction; Behavior

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: July 14, 2020
• Study Start: August 15, 2020
• Primary Completion: October 31, 2022
• Study Completion: November 12, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)