Colo-rectal CancerNCT04889352
Optimizing Timing of Follow-up Colonoscopy
A study testing Access to colonoscopy web app in people with Colo-rectal Cancer and Colon Polyp, run by University of Manitoba at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer, Colon Polyp, Colonic Polyp
- What is being tested?
- Access to colonoscopy web app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Jul 2021to 31 Dec 2022
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
- History of inherited CRC predisposition (Lynch Syndrome, Familial adenomatous polyposis, others);
- Inflammatory bowel disease;
- Partially excised polyp or endoscopy physician recommending early colonoscopy to document complete excision;
- Endoscopy physician documenting a rationale for not repeating colonoscopy in future such as co-morbid conditions.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Health Sciences Center
Winnipeg, Manitoba, R3E 3P4
Winnipeg Regional Health Authority
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: Optimizing Timing of Follow-up Colonoscopy: A Pilot Cluster Randomized Trial to Test the Utility of a Knowledge Translation Tool
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.
Read the detailed description
Study design and intervention: This will be a cluster randomized controlled trial in which individual endoscopy physicians (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to one of two groups: A) provided access to the application (intervention group) or B) not provided access to the application (control group). In the intervention group, the application can be downloaded to smart phones for portability which will allow access in an endoscopy suite or in clinic or used as a reference at other times. It can also be accessed online (all endoscopy rooms in Winnipeg have computers with internet access for the endoscopy physicians' use). The clusters of patients will be defined by the endoscopy physician providing the colonoscopy.
Intervention: Access to the application which will be available both as a web-based as well as a smart phone application.
Setting: Colonoscopies included in the study will be those performed in the Winnipeg endoscopy units.
A research assistant will extract data from medical records maintained by the hospitals and physicians privately. Individual cases of colonoscopies will be identified through the city-wide endoscopy program database. Study data will be collected and managed using the REDCap (Research Electronic Data Capture) electronic data capture tools hosted at the University of Manitoba.
Concealment of Allocation and Randomization: Randomization will be performed after the endoscopy physician consent and enrollment into the study. A computer generated randomization sequence will used in blocks of eight. Stratification for surgical and gastroenterology endoscopy physician will be performed as there might be differential adherence to recommendations by speciality of training.
Blinding: Randomization will be performed and the application distributed by study personnel different than those involved in data extraction from medical records so that the person extracting the data remains blinded to the randomized group assignment.
Patient consent: Patients will not be approached by the study investigators and will get routine care decided by their physicians. Information on recommendations will be extracted from medical records retrospectively; hence, patient consent will not be required.
Duration of treatment and duration of follow-up: This is a cross-sectional study of those undergoing colonoscopy with no follow-up after any pathology is reported.
Outcomes: The primary outcome of analysis will be congruence (agreement) of the colonoscopy physician recommendation with the guideline recommendation.
Endoscopy physician recommendations will be determined from review of the medical records (endoscopy reports and letters/notes in the medical charts). Listing of colonoscopies performed by each enrolled colonoscopy physician will be obtained from the centralised common endoscopy reporting system. Absence of documented recommendations will be considered an incongruent recommendation in the primary analysis and excluded in a sensitivity analysis.
Medical records will be reviewed to obtain the history relevant to determining the timing of surveillance (characteristics of polyps, family history, inclusion and exclusion criteria). Absence of documented relevant history will be considered an incongruent recommendation in the primary analysis and excluded in a sensitivity analysis.
Secondary outcomes will be collected by a survey distributed to the group of endoscopy physicians that were provided the app to determine their opinions about the app. The survey will inquire about ease of use, perception of reliability, likelihood of future use, whether the app provided helpful information and how often they used the app and when. Percentage responses will be tabulated for this descriptive outcome. Investigators will also include open-ended questions about any desired changes to the app.
Another secondary outcome will be the proportion of cases which have a documented recommendation.
Similarly, in this pilot study, the investigators will assess the proportion of the medical records which have complete information (family history of colorectal cancer/polyps, different polyp characteristics) required to make surveillance colonoscopy recommendations as per the guidelines.
- Conditions
- Colo-rectal Cancer, Colon Polyp, Colonic Polyp, Rectal Polyp, Polyp of Colon, Polyp Rectal
- Being tested
- Access to colonoscopy web app
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to colonoscopy web appOther
There is a very high utilization of colonoscopy at both shorter and longer time intervals than the recommended guidelines. Investigators have developed a clinical support tool in which the characteristics of the patients can be inputted and the guideline recommended time interval for surveillance colonoscopy is then provided. This tool uses the recommendations from the current North American national guidelines. The tool has been developed as a web-based application as well as a smart phone application.
| Study group | Role | What they receive |
|---|---|---|
| Access to colonoscopy web app | Experimental | Approximately half of the consenting individual endoscopy physicians in the city (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to the intervention group where they are provided access to an application which indicates recommended timing of follow-up colonoscopy given values for various entered factors. In the intervention group, the application can be downloaded to smart phones for portability which will allow access in an endoscopy suite or in clinic or used as a reference at other times. It can also be accessed online (all endoscopy rooms in Winnipeg have computers with internet access for the endoscopy physicians' use). Access to the application will be password-protected, thereby avoiding exposure of the non-intervention group to the application. The clusters of patients will be defined by the endoscopy physician providing the colonoscopy. Receives: Other: Access to colonoscopy web app |
| Control | No intervention | Approximately half of the consenting individual endoscopy physicians in the city (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to the group where they are not provided access to the application (control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 7 months
Secondary outcomes (11)
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)
Measured: 7 months
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)
Measured: 7 months
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)
Measured: 7 months
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)
Measured: 7 months
Physicians' use of the application (how often used in first month)
graded on an ordinal scale (every day, every week, did not use it)
Measured: 7 months
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)
Measured: 7 months
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)
Measured: 7 months
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)
Measured: 7 months
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 )
Measured: 7 months
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)
Measured: 7 months
Proportion of cases which have a documented recommendation
% of patients with a documented recommendation
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start15 Jul 2021
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a cluster randomized controlled trial in which individual endoscopy physicians (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to one of two groups: A) provided access to the application (intervention group) or B) not provided access to the application (control group). The clusters of patients will be defined by the endoscopy physician providing the colonoscopy.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harminder Singh, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889352
- Sponsor's protocol ID
- H2020:435
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study findings will be disseminated via presentations at professional forums and published in a peer-reviewed journal. No specific feedback will be provided to individual participants as we will perform and report aggregate analysis.
Publications
Potet F, Soullard J. Polyps of the rectum and colon. Gut. 1971 Jun;12(6):468-82. doi: 10.1136/gut.12.6.468.
PubMed 5314569Muto T, Bussey HJ, Morson BC. The evolution of cancer of the colon and rectum. Cancer. 1975 Dec;36(6):2251-70. doi: 10.1002/cncr.2820360944.
PubMed 1203876Stryker SJ, Wolff BG, Culp CE, Libbe SD, Ilstrup DM, MacCarty RL. Natural history of untreated colonic polyps. Gastroenterology. 1987 Nov;93(5):1009-13. doi: 10.1016/0016-5085(87)90563-4.
PubMed 3653628Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
PubMed 8247072Rex DK, Sullivan AW, Perkins AJ, Vemulapalli KC. Colorectal polyp prevalence and aspirational detection targets determined using high definition colonoscopy and a high level detector in 2017. Dig Liver Dis. 2020 Jan;52(1):72-78. doi: 10.1016/j.dld.2019.08.019. Epub 2019 Sep 20.
PubMed 31543411Leddin D, Lieberman DA, Tse F, Barkun AN, Abou-Setta AM, Marshall JK, Samadder NJ, Singh H, Telford JJ, Tinmouth J, Wilkinson AN, Leontiadis GI. Clinical Practice Guideline on Screening for Colorectal Cancer in Individuals With a Family History of Nonhereditary Colorectal Cancer or Adenoma: The Canadian Association of Gastroenterology Banff Consensus. Gastroenterology. 2018 Nov;155(5):1325-1347.e3. doi: 10.1053/j.gastro.2018.08.017. Epub 2018 Aug 16.
PubMed 30121253Singh H, Demers AA, Xue L, Turner D, Bernstein CN. Time trends in colon cancer incidence and distribution and lower gastrointestinal endoscopy utilization in Manitoba. Am J Gastroenterol. 2008 May;103(5):1249-56. doi: 10.1111/j.1572-0241.2007.01726.x. Epub 2008 Jan 11.
PubMed 18190650Lieberman D. How good is your dentist? How good is your endoscopist? The quality imperative. Gastroenterology. 2012 Feb;142(2):194-6. doi: 10.1053/j.gastro.2011.12.016. Epub 2011 Dec 15. No abstract available.
PubMed 22178380Janssen RM, Takach O, Nap-Hill E, Enns RA. Time to Endoscopy in Patients with Colorectal Cancer: Analysis of Wait-Times. Can J Gastroenterol Hepatol. 2016;2016:8714587. doi: 10.1155/2016/8714587. Epub 2016 Apr 6.
PubMed 27446872Sey MS, Gregor J, Adams P, Khanna N, Vinden C, Driman D, Chande N. Wait times for diagnostic colonoscopy among outpatients with colorectal cancer: a comparison with Canadian Association of Gastroenterology targets. Can J Gastroenterol. 2012 Dec;26(12):894-6. doi: 10.1155/2012/494797.
PubMed 23248790Rabeneck L, Paszat LF, Saskin R. Endoscopist specialty is associated with incident colorectal cancer after a negative colonoscopy. Clin Gastroenterol Hepatol. 2010 Mar;8(3):275-9. doi: 10.1016/j.cgh.2009.10.022. Epub 2009 Oct 29.
PubMed 19879970Pinsky PF, Schoen RE. Contribution of Surveillance Colonoscopy to Colorectal Cancer Prevention. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2937-2944.e1. doi: 10.1016/j.cgh.2020.01.037. Epub 2020 Feb 1.
PubMed 32017987Leddin D, Enns R, Hilsden R, Fallone CA, Rabeneck L, Sadowski DC, Singh H; Canadian Association of Gastroenterology. Colorectal cancer surveillance after index colonoscopy: guidance from the Canadian Association of Gastroenterology. Can J Gastroenterol. 2013 Apr;27(4):224-8. doi: 10.1155/2013/232769.
PubMed 23616961Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
PubMed 32044092Rutter MD, East J, Rees CJ, Cripps N, Docherty J, Dolwani S, Kaye PV, Monahan KJ, Novelli MR, Plumb A, Saunders BP, Thomas-Gibson S, Tolan DJM, Whyte S, Bonnington S, Scope A, Wong R, Hibbert B, Marsh J, Moores B, Cross A, Sharp L. British Society of Gastroenterology/Association of Coloproctology of Great Britain and Ireland/Public Health England post-polypectomy and post-colorectal cancer resection surveillance guidelines. Gut. 2020 Feb;69(2):201-223. doi: 10.1136/gutjnl-2019-319858. Epub 2019 Nov 27.
PubMed 31776230
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Timing of Follow-up Colonoscopy: A Pilot Cluster Randomized Trial to Test the Utility of a Knowledge Translation Tool
- ClinicalTrials.gov ID
- NCT04889352
- Acronym / sponsor ID
- H2020:435
- Conditions
- Colo-rectal Cancer, Colon Polyp, Colonic Polyp, Rectal Polyp, Polyp of Colon, Polyp Rectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 May 2021 (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.
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.
Detailed description
Study design and intervention: This will be a cluster randomized controlled trial in which individual endoscopy physicians (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to one of two groups: A) provided access to the application (intervention group) or B) not provided access to the application (control group). In the intervention group, the application can be downloaded to smart phones for portability which will allow access in an endoscopy suite or in clinic or used as a reference at other times. It can also be accessed online (all endoscopy rooms in Winnipeg have computers with internet access for the endoscopy physicians' use). The clusters of patients will be defined by the endoscopy physician providing the colonoscopy.
Intervention: Access to the application which will be available both as a web-based as well as a smart phone application.
Setting: Colonoscopies included in the study will be those performed in the Winnipeg endoscopy units.
A research assistant will extract data from medical records maintained by the hospitals and physicians privately. Individual cases of colonoscopies will be identified through the city-wide endoscopy program database. Study data will be collected and managed using the REDCap (Research Electronic Data Capture) electronic data capture tools hosted at the University of Manitoba.
Concealment of Allocation and Randomization: Randomization will be performed after the endoscopy physician consent and enrollment into the study. A computer generated randomization sequence will used in blocks of eight. Stratification for surgical and gastroenterology endoscopy physician will be performed as there might be differential adherence to recommendations by speciality of training.
Blinding: Randomization will be performed and the application distributed by study personnel different than those involved in data extraction from medical records so that the person extracting the data remains blinded to the randomized group assignment.
Patient consent: Patients will not be approached by the study investigators and will get routine care decided by their physicians. Information on recommendations will be extracted from medical records retrospectively; hence, patient consent will not be required.
Duration of treatment and duration of follow-up: This is a cross-sectional study of those undergoing colonoscopy with no follow-up after any pathology is reported.
Outcomes: The primary outcome of analysis will be congruence (agreement) of the colonoscopy physician recommendation with the guideline recommendation.
Endoscopy physician recommendations will be determined from review of the medical records (endoscopy reports and letters/notes in the medical charts). Listing of colonoscopies performed by each enrolled colonoscopy physician will be obtained from the centralised common endoscopy reporting system. Absence of documented recommendations will be considered an incongruent recommendation in the primary analysis and excluded in a sensitivity analysis.
Medical records will be reviewed to obtain the history relevant to determining the timing of surveillance (characteristics of polyps, family history, inclusion and exclusion criteria). Absence of documented relevant history will be considered an incongruent recommendation in the primary analysis and excluded in a sensitivity analysis.
Secondary outcomes will be collected by a survey distributed to the group of endoscopy physicians that were provided the app to determine their opinions about the app. The survey will inquire about ease of use, perception of reliability, likelihood of future use, whether the app provided helpful information and how often they used the app and when. Percentage responses will be tabulated for this descriptive outcome. Investigators will also include open-ended questions about any desired changes to the app.
Another secondary outcome will be the proportion of cases which have a documented recommendation.
Similarly, in this pilot study, the investigators will assess the proportion of the medical records which have complete information (family history of colorectal cancer/polyps, different polyp characteristics) required to make surveillance colonoscopy recommendations as per the guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This will be a cluster randomized controlled trial in which individual endoscopy physicians (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to one of two groups: A) provided access to the application (intervention group) or B) not provided access to the application (control group). The clusters of patients will be defined by the endoscopy physician providing the colonoscopy.
| Arm | Type | Receives |
|---|---|---|
| Access to colonoscopy web app | Experimental | Other: Access to colonoscopy web appApproximately half of the consenting individual endoscopy physicians in the city (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to the intervention group where they are provided access to an application which indicates recommended timing of follow-up colonoscopy given values for various entered factors. In the intervention group, the application can be downloaded to smart phones for portability which will allow access in an endoscopy suite or in clinic or used as a reference at other times. It can also be accessed online (all endoscopy rooms in Winnipeg have computers with internet access for the endoscopy physicians' use). Access to the application will be password-protected, thereby avoiding exposure of the non-intervention group to the application. The clusters of patients will be defined by the endoscopy physician providing the colonoscopy. |
| Control | No intervention | –Approximately half of the consenting individual endoscopy physicians in the city (gastroenterologists and surgeons) will be randomized (stratified by physician specialty) to the group where they are not provided access to the application (control group). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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).
Key exclusion criteria (6 listed)
- 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.
- History of inherited CRC predisposition (Lynch Syndrome, Familial adenomatous polyposis, others);
- Inflammatory bowel disease;
- Partially excised polyp or endoscopy physician recommending early colonoscopy to document complete excision;
- Endoscopy physician documenting a rationale for not repeating colonoscopy in future such as co-morbid conditions.
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 |
|---|---|---|
| Access to colonoscopy web appThere is a very high utilization of colonoscopy at both shorter and longer time intervals than the recommended guidelines. Investigators have developed a clinical support tool in which the characteristics of the patients can be inputted and the guideline recommended time interval for surveillance colonoscopy is then provided. This tool uses the recommendations from the current North American national guidelines. The tool has been developed as a web-based application as well as a smart phone application. | Other | Access to colonoscopy web app |
Primary outcome
Proportion of cases where the colonoscopy physician recommendations matched with the guideline recommendation
Time frame: 7 months
% of patients whose recommended colonoscopy frequency is in agreement with guideline recommendation based on patient factors and colonoscopy findings'
11 secondary outcomes
Physicians' use of the application (tool reliable)
Time frame: 7 months
Physicians' use of the application (ease of use)
Time frame: 7 months
Physicians' use of the application (how familiar is the information in the tool)
Time frame: 7 months
Physicians' use of the application (how often used)
Time frame: 7 months
Physicians' use of the application (how often used in first month)
Time frame: 7 months
Physicians' use of the application (how often used during endoscopy slate)
Time frame: 7 months
Physicians' use of the application (how often used during non-endoscopy clinical days)
Time frame: 7 months
Physicians' use of the application (impact upon decisions)
Time frame: 7 months
Physicians' use of the application (likelihood of using tool on ongoing basis in practice)
Time frame: 7 months
Physicians' use of the application (main reason provided, among those neutral or unlikely to use on ongoing basis)
Time frame: 7 months
Proportion of cases which have a documented recommendation
Time frame: 7 months
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 6 Apr 2025.
- Background: PubMed 5314569Potet F, Soullard J. Polyps of the rectum and colon. Gut. 1971 Jun;12(6):468-82. doi: 10.1136/gut.12.6.468.
- Background: PubMed 1203876Muto T, Bussey HJ, Morson BC. The evolution of cancer of the colon and rectum. Cancer. 1975 Dec;36(6):2251-70. doi: 10.1002/cncr.2820360944.
- Background: PubMed 3653628Stryker SJ, Wolff BG, Culp CE, Libbe SD, Ilstrup DM, MacCarty RL. Natural history of untreated colonic polyps. Gastroenterology. 1987 Nov;93(5):1009-13. doi: 10.1016/0016-5085(87)90563-4.
- Background: PubMed 8247072Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
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- Individual participant dataSharing planned: No. Study findings will be disseminated via presentations at professional forums and published in a peer-reviewed journal. No specific feedback will be provided to individual participants as we will perform and report aggregate analysis.
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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.
Harminder Singh, MD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to colonoscopy web app in people with Colo-rectal Cancer and Colon Polyp, run by University of Manitoba at 2 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 6 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Proportion of cases where the colonoscopy physician recommendations matched with the guideline recommendation (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889352, which also lists 34 linked publications.
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 6 Apr 2025.