Colo-rectal Cancer Clinical Trial
Official title:
Optimizing Timing of Follow-up Colonoscopy: A Pilot Cluster Randomized Trial to Test the Utility of a Knowledge Translation Tool
Verified date | January 2024 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillance colonoscopy. To assess whether access to the tool improves adherence to recommended guidelines for follow-up colonoscopy intervals. Colonoscopy is commonly used for surveillance of patients with high risk of developing colorectal cancer, including those with family history of colorectal cancer and those with colorectal polyps. The recommended timing of surveillance colonoscopy varies by the estimated risk for development of colorectal cancer. The estimated risk varies by family history of colorectal cancer (number of affected individuals, age of the persons affected with CRC) and characteristics of the colorectal polyps (size, number, and histology of colorectal polyps (tubular or villous; high grade or low-grade dysplasia; sessile serrated polyp, sessile serrated polyp with dysplasia, hyperplastic polyp or traditional serrated adenomas). Guidelines take all of these factors into account in the recommendations for follow-up colonoscopy and hence are difficult to recall for the busy clinicians. Colonoscopy surveillance is frequently performed at shorter or longer than the recommended time intervals. The investigators have developed a smart phone application in which the characteristics of the patients can be inputted and the tool provides the recommended time interval for surveillance colonoscopy, based on North American guidelines. The investigators are proposing a pilot randomized trial to determine sample size estimates for a larger trial to assess the utility of this application in clinical practice.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: For physician participants, there are no age limits/parameters. All physicians performing colonoscopy on adult patients in Winnipeg will be eligible to participate (other than those involved in pilot testing and study investigators). Participating physicians will be informed that the introduced intervention will be an information tool to help improve care for individuals undergoing colonoscopy, and will be asked to consent to review of their patient records. Participating physicians will be informed that no individual-level information will be disclosed at any time and all analysis will be on anonymized data. For patient participants: - Patients must be older than 50 years and up to 75 years old for inclusion in the study data. - Adequate bowel preparation defined by Boston Bowel Preparation Scale Score of = 2 in each of segments of the colon (Boston bowel prep scale score recording is mandatory in the Winnipeg city-wide endoscopy reporting system); - Colonoscopy completed to the cecum/ileocolonic anastomosis; - Colonoscopy performed between 1 to 4 months before randomization of endoscopy physician (to determine baseline adherence) or between 3 to 7 months after randomization (to determine effect of the intervention). Exclusion Criteria: Physicians will be excluded if they are away for more than six weeks continuously in the six months after randomization. In this situation, an alternate physician will be recruited and randomized. Thus there is no anticipated loss of follow-up. Patients will be excluded if any of the following criteria are met: 1. History of inherited CRC predisposition (Lynch Syndrome, Familial adenomatous polyposis, others); 2. Inflammatory bowel disease; 3. Partially excised polyp or endoscopy physician recommending early colonoscopy to document complete excision; 4. Endoscopy physician documenting a rationale for not repeating colonoscopy in future such as co-morbid conditions. |
Country | Name | City | State |
---|---|---|---|
Canada | Health Sciences Center | Winnipeg | Manitoba |
Canada | Winnipeg Regional Health Authority | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of cases where the colonoscopy physician recommendations matched with the guideline recommendation | % of patients whose recommended colonoscopy frequency is in agreement with guideline recommendation based on patient factors and colonoscopy findings' | 7 months | |
Secondary | Physicians' use of the application (tool reliable) | graded on an ordinal scale (strongly disagree, disagree, neutral, agree, strongly agree), N/A - Have not used app) | 7 months | |
Secondary | Physicians' use of the application (ease of use) | Ease of use graded on an ordinal scale (strongly disagree, disagree, neutral, agree), strongly agree, N/A - Have not used app) | 7 months | |
Secondary | Physicians' use of the application (how familiar is the information in the tool) | graded on an ordinal scale (very familiar, familiar, unsure, new, very new, N/A - Have not used app) | 7 months | |
Secondary | Physicians' use of the application (how often used) | graded on an ordinal scale (every day, every week, every month, less than once a month, did not use it) | 7 months | |
Secondary | Physicians' use of the application (how often used in first month) | graded on an ordinal scale (every day, every week, did not use it) | 7 months | |
Secondary | Physicians' use of the application (how often used during endoscopy slate) | graded on an ordinal scale (never, less than 5%, more than 5% but less than 50%, more than 50%, N/A - have not used the app) | 7 months | |
Secondary | Physicians' use of the application (how often used during non-endoscopy clinical days) | graded on an ordinal scale (never, less than 5%, more than 5% but less than 50%, more than 50%, N/A - have not used the app) | 7 months | |
Secondary | Physicians' use of the application (impact upon decisions) | graded on an ordinal scale (never, less than 5%, more than 5% but less than 50%, more than 50%, N/A - have not used the app) | 7 months | |
Secondary | Physicians' use of the application (likelihood of using tool on ongoing basis in practice) | graded on an ordinal scale (very likely, likely, neutral, not likely, very unlikely ) | 7 months | |
Secondary | Physicians' use of the application (main reason provided, among those neutral or unlikely to use on ongoing basis) | graded on an ordinal scale (difficult to use, not helpful, too time consuming, other) | 7 months | |
Secondary | Proportion of cases which have a documented recommendation | % of patients with a documented recommendation | 7 months |
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