Raising Awareness of Colorectal Screening in American Indian Communities

NCT07515729 | Not Yet Recruiting

• 1 other identifier: AIC-DC
• Study Type: observational
• Target: 446
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Cancer (CRC)

Keywords

American Indian (AI); Implementation Science (IS); Alaskan Native (AN)

Outcome Measures

Primary Outcomes (1)

• 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.

  4 year

Study Arms (3)

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

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.

Interventions

Navigator-led intervention OTHER

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.

American Indians needing diagnostic colonoscopy after a positive stool-based screen.

Eligibility Criteria

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

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma City Indian Clinic: collaborator
• Indian Health Service (IHS): collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Mark Doescher, MD, MSPH

  University of Oklahoma Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Doescher, MD, MSPH

CONTACT

05-271-4808; SCC-IIT-Office@ouhsc.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share