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
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | March 15, 2023 |
Est. primary completion date | September 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | McGill University Health Centre | Montréal | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | University Health Network | Toronto | Ontario |
Canada | St Paul's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Jewish General Hospital | McGill University Health Centre/Research Institute of the McGill University Health Centre, Mount Sinai Hospital, Canada, Providence Healthcare, University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Patient activation measures | 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 | |
Secondary | Change in Patient activation measures | 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. | |
Secondary | 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) | 1 week before the launch of the app | |
Secondary | 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) | 6 months after using the app. |
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