Raising Awareness of Colorectal Screening in American Indian Communities (AIC-DC)

May 8, 2026 updated by: University of Oklahoma

An American Indian Community-Engaged Approach to Increasing Diagnostic Colonoscopy

This study focuses exclusively on American Indian individuals within their communities to enhance health equity and address a critical tribal health priority. American Indian populations experience some of the highest colorectal cancer (CRC) mortality rates in the nation. By conducting research within these communities, this study aims to improve early detection, prevention, and treatment strategies tailored to their specific needs. The findings will help develop targeted interventions to reduce CRC disparities and improve health outcomes for American Indian individuals.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to close gaps in diagnostic follow-up for American Indian (AI) patients by identifying barriers and facilitators to receiving diagnostic colonoscopies, with a focus on social determinants of health (SDOH). Insights from this will guide an implementation science (IS) study evaluating a CRC Screening Navigator-led intervention to improve access. The primary outcome is the annual percentage change in AI adults (ages 45-75) with positive stool-based screens who complete a diagnostic colonoscopy within 60 days.

Study Type

Observational

Enrollment (Estimated)

446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

American Indian (AI) adults aged 45-75 years with positive stool-based screens who are successfully navigated to diagnostic colonoscopy within 60 days.

Description

Inclusion Criteria:

  • Inclusion for patient interviews: American Indian Men and Women eligible for services at OKCIC and IHS facilities. American Indian Men and Women aged 45 to 75 years who are eligible for colorectal cancer screening.
  • Inclusion for the provider/staff/leadership interviews: Adults (18 to 80 years old) who are employed by the participating clinic.
  • Inclusion for caregiver/community member interviews: Adults aged 18 and over who are caregivers for patients eligible for CRC screening. Community members who are aged 18 and over.

Exclusion Criteria:

  • Exclusion for patient interviews: Non-American Indian Men and Women and American Indian Men and Women that are not in the required age range for CRC screenings.
  • Exclusion for provider/staff/leadership interviews: Employees less than 18 years old or people not employed by the participating clinics.
  • Exclusion for caregivers/community members: People less than 18 years old, not a caregiver for a patient eligible for CRC screening. People less than 18 years old and not a member of the community where the participating clinics are located.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
American Indians needing diagnostic colonoscopy after a positive stool-based screen.
In year 1; baseline proportion of patients needing diagnostic colonoscopy (after an initial positive stool-based screen) who receive it within 30 days, 60 days, and 90 days over the 12 months of Year 1 will be calculated, with 60-day completion being the primary focus. Findings will be analyzed by age group, gender, geographic residence location using Rural-Urban Continuum Codes (RUCCs),91 health insurance coverage status, and clinic.
Other: Navigator-led intervention
Navigator will review the proposed implementation plan with PCPs, clinic staff and administrators to address how diagnostic colonoscopy can fit smoothly within overall clinic operations.
provider/staff/leadership
Employees above 18 years old or people not employed by the participating clinics will be given 32-item Change Process Capability Questionnaire (CPCQ). The CPCQ measures practice readiness to manage the system changes needed to implement evidence-based recommendations by incorporating items identified by a panel of implementation leaders as the most important organizational factors and strategies. Three to six individuals per site will complete pre- and post CPCQs: 1-2 project champion clinicians; 1-2 nursing staff; 1-2 admin. staff (e.g., office manager).
caregivers/community members
50 provider/community interviews will per collected to develop strategies that address potential barriers and facilitators to diagnostic follow-up within each ITU setting using a Navigator-led intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of a clinical intervention on CRC diagnostic testing outcomes
Time Frame: 4 year
Measures the percentage of screen-positive patients successfully navigated to diagnostic colonoscopy within 60 days. The study will use a Hybrid Type 2 pretest/posttest design. A pretest pilot (40 patients across all sites) will inform full-scale implementation, completed in Year 2 within six months. Full-scale implementation (252 patients) will run from Year 2, Month 7 to Year 4, Month 6, assessing pragmatic effectiveness and implementation outcomes.
4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Indian Health Service (IHS)
Oklahoma City Indian Clinic

Investigators

  • Principal Investigator: Mark Doescher, MD, MSPH, University of Oklahoma Stephenson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIC-DC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Cancer (CRC)

Clinical Trials on Navigator-led intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe