Patient EmpowermentNCT04469426
Interactive Online Informational and Peer Support App for Patients with Low Anterior Resection Syndrome
A study testing Interactive online informational and peer support app in people with Patient Empowerment and Low Anterior Resection Syndrome, run by Jewish General Hospital at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Empowerment, Low Anterior Resection Syndrome, Colo-rectal Cancer
- What is being tested?
- Interactive online informational and peer support app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Aug 2020to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Jewish General Hospital
Montreal, Quebec, H3T1E2
McGill University Health Centre
Montreal, Quebec
Mount Sinai Hospital
Toronto, Ontario
University Health Network
Toronto, Ontario
St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Empowerment, Low Anterior Resection Syndrome, Colo-rectal Cancer, Peer Group, Patient Satisfaction, Health Attitude
- Being tested
- Interactive online informational and peer support app
- Keywords
- colorectal surgery, peer support
- Medical subject headings
- Patient Participation, Low Anterior Resection Syndrome, Colonic Neoplasms, Patient Satisfaction, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive online informational and peer support appOther
The app contains LARS information, bowel function diaries, and online platform with trained peer support mentor
| Study group | Role | What they receive |
|---|---|---|
| Informational online app group | Experimental | Participants will have access to an interactive online peer support app developed by the research team. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months after using the app.
Secondary outcomes (4)
Patient activation measures
Questionnaire measures patient activation before app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).
Measured: 1 week before the launch of the app
Change in Patient activation measures
Questionnaire measures patient activation after app use. Maximum score 52 (higher patient activation), Minimum score 13 (lower patient activation).
Measured: 6 months after using the app.
Bowel function Low Anterior Resection Syndrome score
Questionnaire measures bowel function before app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)
Measured: 1 week before the launch of the app
Bowel function Low Anterior Resection Syndrome score
Questionnaire measures bowel function after app use. Maximum score 42 (worse bowel function). Minimum score 0 (better bowel function)
Measured: 6 months after using the app.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start15 Aug 2020
- Primary completion31 Oct 2022
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EmpowermentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Healthcare, Mount Sinai Hospital, Canada, University Health Network, Toronto, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Dr. Marylise Boutros, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469426
- Sponsor's protocol ID
- JGH-2020-2073
- Status last verified
- Nov 2024
- First submitted
- 23 Mar 2020
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Online Informational and Peer Support App for Patients with Low Anterior Resection Syndrome (LARS): a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04469426
- Acronym / sponsor ID
- JGH-2020-2073
- Conditions
- Patient Empowerment, Low Anterior Resection Syndrome, Colo-rectal Cancer, Peer Group, Patient Satisfaction, Health Attitude
- Keywords
- colorectal surgery, peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- Providence Healthcare, Mount Sinai Hospital, Canada, University Health Network, Toronto, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informational online app group | Experimental | Other: Interactive online informational and peer support appParticipants will have access to an interactive online peer support app developed by the research team. |
| Booklet only | No intervention | –Participants will only have access to the educational booklet on LARS developed by the colorectal research team. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive online informational and peer support appThe app contains LARS information, bowel function diaries, and online platform with trained peer support mentor | Other | Informational online app group |
Primary outcome
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).
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).
4 secondary outcomes
Patient activation measures
Time frame: 1 week before the launch of the app
Change in Patient activation measures
Time frame: 6 months after using the app.
Bowel function Low Anterior Resection Syndrome score
Time frame: 1 week before the launch of the app
Bowel function Low Anterior Resection Syndrome score
Time frame: 6 months after using the app.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive online informational and peer support app in people with Patient Empowerment and Low Anterior Resection Syndrome, run by Jewish General Hospital at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - C30 questionnaire (time frame: 1 week before the launch of the app). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.