Stool DNA to Improve Colorectal Cancer Screening Among Alaska Native People

NCT04336397 | Completed Results DMC FDA Device

• 1 other identifier: 1R01CA247642-01
• Study Type: interventional
• Target: 2,029
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Colorectal Cancer

Keywords

screening

Outcome Measures

Primary Outcomes (1)

• Colorectal Cancer Screening by Study Arm

  Incident CRC screening episode defined as having at least one of the following within 1 year of follow-up after randomization and intervention: colonoscopy; MT-sDNA with a negative result; or MT-sDNA with a positive result followed by a colonoscopy within 1 year.

  1 year

Secondary Outcomes (2)

• Test Requested (MT-sDNA or Colonoscopy)

  1 year

• MT-sDNA Diagnostic Follow-up

  1 year

Study Arms (3)

High Intensity

ACTIVE COMPARATOR

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.

Diagnostic Test: Multi-target stool DNA test; Diagnostic Test: Colonoscopy

Medium Intensity

ACTIVE COMPARATOR

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.

Diagnostic Test: Multi-target stool DNA test; Diagnostic Test: Colonoscopy

Usual Care

NO INTERVENTION

usual care (i.e., opportunistic screening recommendation at a clinic visit)

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

Also known as: Cologuard

High Intensity; Medium Intensity

Colonoscopy DIAGNOSTIC_TEST

Cluster randomized trial of high and medium intensity outreach with MT-sDNA or colonoscopy compared with usual care

High Intensity; Medium Intensity

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alaska Native adults eligible to receive health care through the Alaska Tribal Health System
• Active health system users with at least one Alaska Tribal Health System visit in the previous three years
• Due for colorectal cancer screening (have not had colonoscopy in past 10 years or fecal occult blood test in past 1 year or flexible sigmoidoscopy in past 5 years)

You may not qualify if:

• First-degree relative diagnosed with CRC at age 60 or younger
• History of familial adenomatous polyposis
• Hereditary non-polyposis CRC
• Previous colonoscopic evidence of inflammatory bowel disease, Crohn's disease, colorectal adenomas, or CRC
• Known history of colectomy

Sponsors & Collaborators

• Alaska Native Tribal Health Consortium: lead
• Mayo Clinic: collaborator
• Yukon Kuskokwim Health Corporation: collaborator

Study Sites (1)

Yukon-Kuskokwim Health Corporation

Bethel, Alaska, 99559, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and Caveats

This study was limited to a single population group located in one geographical region.

Results Point of Contact

• Title: Dr. Diana Redwood
• Organization: Alaska Native Tribal Health Consortium

dredwood@anthc.org

907-729-3959

Study Officials

• Diana Redwood, PhD

  Alaska Native Tribal Health Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3-arm cluster-randomized controlled trial

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: April 29, 2021
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2025
• Access Criteria: Interested investigators would be required to enter into a data sharing agreement with the Alaska Native Tribal Health Consortium that includes the following: 1) a commitment to follow the Tribal approval process from concept proposal to dissemination; 2) a commitment to using the data only for research purposes and not to identify any individual participant; 3) a commitment to securing the data using appropriate computer technology; and 4) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)