Colorectal Cancer (CRC)AIC-DCNCT07515729
Raising Awareness of Colorectal Screening in American Indian Communities
An observational study of Colorectal Cancer (CRC), run by University of Oklahoma.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Navigator-led intervention
- How many people
- 446 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Navigator-led intervention
- Keywords
- American Indian (AI), Implementation Science (IS), Alaskan Native (AN)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator-led interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma City Indian Clinic, Indian Health Service (IHS)
- Responsible party
- Sponsor
- Investigators
- Mark Doescher, MD, MSPH, Principal investigator, University of Oklahoma Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515729
- Sponsor's protocol ID
- AIC-DC
- Acronym
- AIC-DC
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An American Indian Community-Engaged Approach to Increasing Diagnostic Colonoscopy
- ClinicalTrials.gov ID
- NCT07515729
- Acronym / sponsor ID
- AIC-DC / AIC-DC
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- American Indian (AI), Implementation Science (IS), Alaskan Native (AN)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma City Indian Clinic, Indian Health Service (IHS)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| American Indians needing diagnostic colonoscopy after a positive stool-based screen. | – | Other: Navigator-led interventionIn 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. |
| 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator-led interventionNavigator will review the proposed implementation plan with PCPs, clinic staff and administrators to address how diagnostic colonoscopy can fit smoothly within overall clinic operations. | Other | American Indians needing diagnostic colonoscopy after a positive stool-based screen. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Doescher, MD, MSPH principal investigator
University of Oklahoma Stephenson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (CRC), run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Doescher, MD, MSPH (05-271-4808, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of a clinical intervention on CRC diagnostic testing outcomes (time frame: 4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.