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NCT04336397 · ClinicalTrials.gov registry record · NA
Stool DNA to Improve Colorectal Cancer Screening Among Alaska Native People
A NA study, sponsored by Alaska Native Tribal Health Consortium.
- Completed
- Registry status
- NA
- Development phase
- 2,029
- Enrollment target
NCT04336397 is a NA study that has completed, run by Alaska Native Tribal Health Consortium. The registered enrollment target is 2,029 participants.
The verdict
NCT04336397, a NA study, has completed, sponsored by Alaska Native Tribal Health Consortium.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,029 participants
- Enrollment target
Study Summary
Only 59% of Alaska Native people have been adequately screened for colorectal cancer (CRC) despite having the highest reported incidence of CRC in the world. A new at-home multi-target stool DNA screening test (MT-sDNA; Cologuard®) with high sensitivity for pre-cancerous polyps and CRC is now available. MT-sDNA has not been tested for feasibility or acceptability within the Alaska tribal health care delivery system, and it is unknown whether use of this new test will increase Alaska Native CRC screening rates. The long-term study goal is to improve screening and reduce CRC-attributable mortality. The objective of this application is to test the effectiveness of MT-sDNA for increasing CRC screening in Alaska Native communities using a mixed methods, community-based participatory research (CBPR) approach. The study will be conducted in collaboration with regional Tribal health organizations responsible for providing health care to geographically remote Alaska Native communities. Although the proposed implementation strategy is evidence-informed and promising, it is novel in that MT-sDNA has not been evaluated in the tribal health setting or among rural/remote populations. Using the RE-AIM Model, the research will be multi-level, examining influence on patients, providers, and tribal health organizations (THOs). This research study will pursue two specific aims: (1) Identify patient-, provider-, and system-level factors associated with CRC screening preferences, uptake, and follow-up; and (2) test the effectiveness of graded intensity MT-sDNA intervention in the Alaska Native community setting. For the first aim, focus groups with Alaska Native people who are not adherent to CRC screening guidelines and interviews with healthcare providers will be used to identify factors for future intervention. For the second aim, a three-arm cluster randomized controlled trial (high intensity with patient navigation, medium intensity with mailed reminders, usual care) will provide e
Interventions
- DIAGNOSTIC_TEST Colonoscopy
- DIAGNOSTIC_TEST Multi-target stool DNA test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,029 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2024-09-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04336397
The ClinicalTrials.gov registry entry for NCT04336397 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,029 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alaska Native Tribal Health Consortium, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Colonoscopy is the first listed.
NCT04336397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04336397 about?
NCT04336397 is a clinical study titled "Stool DNA to Improve Colorectal Cancer Screening Among Alaska Native People". Only 59% of Alaska Native people have been adequately screened for colorectal cancer (CRC) despite having the highest reported incidence of CRC in the world. A new at-home multi-target stool DNA screening test (MT-sDNA; Cologuard®) with high sensitivity for pre-cancerous polyps and CRC is now availa...
What is the current status of trial NCT04336397?
This trial is currently completed. It is a NA study. The enrollment target is 2,029 participants. The study started on 2021-04-29. Estimated completion is 2024-09-15.
What interventions are being tested in trial NCT04336397?
The interventions under investigation include: Colonoscopy (DIAGNOSTIC_TEST), Multi-target stool DNA test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04336397?
This trial is sponsored by Alaska Native Tribal Health Consortium, which has 5 total clinical trials registered on ClinicalTrials.gov.
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