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

August 31, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oklahoma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indian Health Service (IHS)
Oklahoma City Indian Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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