Raising Awareness of Colorectal Screening in American Indian Communities

ConditionColorectal Cancer (CRC)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age45-75

SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

Navigator-led intervention
Other 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.

Treatment groups

446 Participants

are divided into 3 treatment groups

Group A: American Indians needing diagnostic colonoscopy after a positive stool-based screen.1 intervention

Group B: provider/staff/leadership0 interventions

Group C: caregivers/community members0 interventions

Trial outcomes

Primary outcomes

Effects of a clinical intervention on CRC diagnostic testing outcomes

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.

Time frame

4 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Oklahoma City Indian Clinic

Collaborator

Indian Health Service (IHS)