Stool DNA to Improve Colorectal Cancer Screening Among Alaska Native People

Part of paid clinical trials in Bethel, Alaska.

Sponsor
Alaska Native Tribal Health Consortium
Study ID
NCT04336397
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Multi-target stool DNA test — DIAGNOSTIC_TEST
    Cluster randomized trial of high and medium intensity outreach with MT-sDNA or colonoscopy compared with usual care
  • Colonoscopy — DIAGNOSTIC_TEST
    Cluster randomized trial of high and medium intensity outreach with MT-sDNA or colonoscopy compared with usual care

Study Details

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 evidence on the MT-sDNA usefulness (MT-sDNA sample quality and neoplastic yield) as well as the first data on MT-sDNA follow up adherence rates in the Alaska Native population, which will inform plans to scale-up the intervention model. This research has the potential to sustainably improve public health by increasing CRC screening rates among a rural/remote tribal population as well as provide a model for other integrated health systems that provide care to high-risk or underserved populations in the U.S. and worldwide.

Key Dates

Start date
Apr 29, 2021
Status verified
Nov 2025
Primary completion
Sep 15, 2024
Completion
Sep 15, 2024

Study Design

Enrollment
2,029 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: High Intensity
    Navigated tribal health worker telephone outreach up to 5 telephone calls and 1 mailed culturally appropriate educational material describing CRC screening options available. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
  • Active Comparator: Medium Intensity
    1 mailed culturally appropriate educational material describing CRC screening options available and 1 telephone call from a tribal health worker. If MT-sDNA selected, sent a MT-sDNA kit and follow-up reminders.
  • No Intervention: Usual Care
    usual care (i.e., opportunistic screening recommendation at a clinic visit)

Primary Outcome Measure

Colorectal Cancer Screening by Study Arm [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yukon-Kuskokwim Health CorporationBethelAlaska99559-

Find similar trials in Bethel, AK

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Yukon-Kuskokwim Health Corporation· Bethel, AK

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