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Not yet recruiting NCT07515729

Raising Awareness of Colorectal Screening in American Indian Communities

Observational Colorectal Cancer (CRC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Navigator-led intervention.
Who it may be relevant to
Registry conditions: Colorectal Cancer (CRC). Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An American Indian Community-Engaged Approach to Increasing Diagnostic Colonoscopy

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Effects of a clinical intervention on CRC diagnostic testing outcomes [Time frame: 4 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07515729 · AIC-DC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗