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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469426
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
Providence Healthcare
Mount Sinai Hospital, Canada
University Health Network, Toronto
McGill University Health Centre/Research Institute of the McGill University Health Centre
Information provided by (Responsible Party):
Dr. Marylise Boutros, Jewish General Hospital

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.

Condition or disease Intervention/treatment Phase
Patient Empowerment Low Anterior Resection Syndrome Colo-rectal Cancer Peer Group Patient Satisfaction Health Attitude Health Knowledge, Attitudes, Practice Other: Interactive online informational and peer support app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interactive Online Informational and Peer Support App for Patients With Low Anterior Resection Syndrome (LARS): A Multicenter Randomized Controlled Trial
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2023

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.



Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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)

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469426


Contacts
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Contact: Jeongyoon Moon, MD 5145676370 jeongyoon.moon@mail.mcgill.ca
Contact: Sarah Sabboobeh, MSc 5143408222 ext 25996 sarah.sabboobeh@ladydavis.ca

Locations
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Canada, British Columbia
St Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Jenny Moon, MD    5145676370    jeongyoon.moon@mail.mcgill.ca   
Contact: Willis Cao    604.682.2344 ext 66005    wcao1@providencehealth.bc.ca   
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: Selina Schmocker       Selina.Schmocker@sinaihealth.ca   
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Taariq Shaikh       Taariq.Shaikh@uhnresearch.ca   
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T1E2
Contact: Sarah Sabboobeh, MSc    5143408222 ext 25996    sarah.sabboobeh@ladydavis.ca   
Contact: Jenny Moon, MD    5145676370    jeongyoon.moon@mail.mcgill.ca   
McGill University Health Centre Recruiting
Montréal, Quebec, Canada
Contact: Jenny Moon       jeongyoon.moon@mail.mcgill.ca   
Sponsors and Collaborators
Jewish General Hospital
Providence Healthcare
Mount Sinai Hospital, Canada
University Health Network, Toronto
McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Dr. Marylise Boutros, Assistant Professor, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT04469426    
Other Study ID Numbers: JGH-2020-2073
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Marylise Boutros, Jewish General Hospital:
colorectal surgery
peer support
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes