Stool DNA Test for Colorectal Cancer

Palo Alto (17 mi)

Overseen byDiana Redwood, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Alaska Native Tribal Health Consortium

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Social Ecological 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.

Eligibility Criteria

This trial is for Alaska Native adults who can get healthcare through the Alaska Tribal Health System, have visited it within the last three years, and are due for colorectal cancer screening. It's not open to those with certain genetic conditions or a history of bowel diseases, polyps, cancer, or colectomy.

Exclusion Criteria

I have a family history of multiple colon polyps.

I have had colon issues like IBD, Crohn's, polyps, or colon cancer.

I have a family history of non-polyposis colorectal cancer.

I have had surgery to remove part or all of my colon.

Treatment Details

The study tests an at-home stool DNA test (Cologuard®) to see if it increases colorectal cancer screening rates in Alaska Native communities. The research includes focus groups and a three-arm randomized trial comparing different levels of intervention intensity.

3Treatment groups

Active Control

Group I: Usual CareActive Control1 Intervention

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

Group II: High IntensityActive Control1 Intervention

navigated tribal health worker outreach, a mailed MT-sDNA kit, mailed culturally appropriate educational material describing CRC screening options available and follow-up reminders

Group III: Medium IntensityActive Control1 Intervention

navigated tribal health worker outreach, a mailed MT-sDNA kit, mailed culturally appropriate educational material describing CRC screening options available and follow-up reminders