Feasibility of a Multi-Channel Intervention to Promote Colorectal Cancer Screening Among American Indians in Oklahoma (YVONNE)

July 28, 2026 updated by: University of Oklahoma
The Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS) Program addresses major regional CRC screening disparities among AI in Oklahoma. The investigators are engaged in a participatory and collaborative effort with Tribal Nations, Area Indian Health Boards, and Indian Health Service (IHS) healthcare facilities. The overall objective of this proposal is to leverage these relationships and examine the feasibility of co-developing and disseminating a v-TCHE as part of a multi-channel communication intervention. To achieve this objective, the investigators have partnered with IHS Clinton Service Unit, which serves members of the Cheyenne and Arapaho Tribes. The intervention will be disseminated across two channels: (1) Social Media (i.e., accessed via online study adverts) and (2) Clinic (i.e., direct messaging to patients via a study link in a SMS text). Across both channels, the investigators will examine reach of the intervention and its potential efficacy via a randomized controlled trial. Once participants click on the study link they will be randomized 1:1 to one of two intervention conditions: (1) watch a Narrative Testimonial Video of a real-life Tribal community health educator (control) or (2) an interaction with a v-TCHE. Participants will then complete a post-intervention survey, in which they can click to order a FIT kit afterwards.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

Colorectal cancer (CRC) is the second-leading cause of cancer death in both men and women in the United States.1 Compared to national averages, American Indians (AI) endure a disproportionate burden of CRC incidence and CRC-specific mortality.2 Screening is an effective early detection strategy to decrease preventable CRC-related deaths, but AI have some of the lowest CRC screening rates. In Oklahoma, only 51% of AI are up to date with screening compared to nearly two-thirds of eligible US adults.2 Efforts to improve screening rates have focused on increasing access to home stool screening (i.e.. fecal immunochemical test; FIT), as many AI live in rural communities and must drive long distances to access screening services. Tribal community health educators (TCHE) are an effective strategy to promote FIT screening within AI communities as they can overcome historical mistrust, health literacy gaps, and provide culturally concordant educational messaging. However, success of TCHE is limited by their reach as they cannot logistically engage with all necessary AI communities. As such, there remains a critical need to develop novel and scalable multi-channel communication interventions that can mimic the benefits of a TCHE and provide easy access to FIT kits among AI in Oklahoma. Virtual human technology, which uses 3D models to create photorealistic virtual humans, offers an innovative approach to create a virtual TCHE (v-TCHE) and may overcome the logistical barriers inherent with in-person delivered health education. The investigative team have previously used this technology to create race- and culturally concordant virtual characters to deliver CRC screening recommendations (R01CA207689) and support clinical trials enrollment (R24AG074867; U01CA274970) among rural and racial minority patients in Florida. This proposal would support codevelopment and testing of the first virtual human tailored for AI patients. The investigators believe a v-TCHE can engender the positive source cues that invoke feelings of trust among AI patients that an in-person TCHE provides. The novelty and customization of a v-TCHE can further enhance interest and perceived cultural relevance of CRC screening information. Moreover, the interactive nature, compared to other more passive communication strategies (e.g., narrative testimonial videos), can empower decisionIRB NUMBER: 16811 IRB APPROVAL DATE: 04/10/2024 Neil, Version # IRB version 03/12/2019 3 making and aligns with cultural preference of self-determination within Tribal practices while still promoting CRC screening.3 Aim 1. Co-develop a multi-channel communication intervention with AI in Oklahoma. Approach. Phase 1 will conduct 4 focus groups (n=6-8 per group) of AI patients from IHS Clinton Service Unit to co-develop the communication intervention content. Phase 2 will record the Narrative Testimonial Video and create the v-TCHE. Phase 3 will employ a community advisory board (CAB) for final review of the interventions before dissemination. Aim 2. Determine the reach and potential efficacy of a multi-channel communication intervention to promote CRC screening among AI in Oklahoma. Approach. The investigators aim to accrue 150 AI patients, aged 45-75 and not up to date with CRC screening, who live within IHS Clinton Service Unit catchment area. Reach (primary outcome) will be determined by the proportion of participants who successfully engage with the intervention, compared across intervention channels (Social Media vs. Clinic). Potential efficacy will be determined by (1) post-intervention differences in knowledge about CRC symptoms and screening and (2) the proportion of participants who order and return a FIT kit within 30 days, compared between study conditions (i.e., Narrative Testimonial Video vs. v-TCHE interaction) and intervention channels (Social Media vs. Clinic). Public Health Impact. This proposal is highly responsive to Track 2 in the PA-20-272 as it attempts to address inequities in CRC outcomes among AI populations. The investigators examine the feasibility of co-developing and disseminating a multi-channel communication intervention to promote a United States Preventive Services Taskforce recommended cancer screening test. If successful, findings will support a first-of-its-kind, highly scalable approach to overcome the reach limitations that Tribal community health educators face. A future R01 will determine the efficacy of different v-TCHE to promote FIT screening across other Tribal healthcare systems.

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.
Interventional

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.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • TSET Health Promotion Research Center
        • Contact:

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

No

Description

Inclusion Criteria:

  • Age 45-75 Live within IHS Clinton Service Unit catchment area Fluent in English and read at or above 6th grade level Self report as American Indian or have CDIB

Exclusion Criteria:

  • Self report up to date with CRC screening FIT within 1 year

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Narrative Testimonial Video of a Tribal Community Health Educator
The narrative testimonial will provide a first-person recording of a real Tribal community health educator. In addition to the kernel information, the narrative video will employ culturally concordant storytelling about their personal experiences helping AI patients get screened and positive outcomes associated with early detection.
Behavioral: Narrative Testimonial Video
The narrative testimonial will provide a first-person recording of a real Tribal community health educator. In addition to the kernel information, the narrative video will employ culturally concordant storytelling about their personal experiences helping AI patients get screened and positive outcomes associated with early detection.
Active Comparator: v-TCHE Interaction
Participants can interact via a set of authored responses or speak freely to the vTCHE. The v-TCHE uses Google Speech-to-Text to convert participant speech into text and Google's DialogFlow logs participants' selections, utterances, and interactions with the vTCHE. The interaction will elicit individual preferences, address concerns about CRC, and empower decision-making while still promoting CRC screening.
Behavioral: v-TCHE Interaction
Participants can interact via a set of authored responses or speak freely to the vTCHE. The v-TCHE uses Google Speech-to-Text to convert participant speech into text and Google's DialogFlow logs participants' selections, utterances, and interactions with the vTCHE. The interaction will elicit individual preferences, address concerns about CRC, and empower decision-making while still promoting CRC screening.

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
Reach
Time Frame: From enrollment to the end of the intervention at 30 days
The percentage of participants who successfully engage with the intervention (i.e., via click through rate) and compared across intervention channels (Social Media vs. Clinic). A GIS analysis will determine where reach was geographically greatest.
From enrollment to the end of the intervention at 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Potential efficacy
Time Frame: From enrollment to the end of intervention at 30 days
Participants will complete minimal survey assessments for study intervention. Post-intervention survey measures will be limited to multi-dimensional objective assessments of knowledge about CRC and screening, confidence in identifying CRC symptoms, key theoretical constructs associated with CRC screening (e.g., self-efficacy, response efficacy), and intervention evaluation (e.g., acceptability, cultural appropriateness).
From enrollment to the end of intervention at 30 days
FIT Kit Screening
Time Frame: 30 days
The proportion of participants who order and return a FIT kit within 30 days, compared between intervention conditions (i.e., Narrative Testimonial Video vs. v-TCHE interaction) and intervention channels (Social Media vs. Clinic). Participants who return a FIT kit and report an abnormal finding, will be provided multiple forms of navigation to support follow-up care, including SMS text message/email and phone calls from study and clinic navigators.
30 days

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

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: Jordan Neil, PhD, University of Oklahoma

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.
August 30, 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.
September 30, 2026

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.
September 30, 2026

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).
October 28, 2025

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.
November 19, 2025

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.
November 28, 2025

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.
July 30, 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.
July 28, 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.
July 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.
  • 16811P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Research analysis will only be conducted by IRB-approved key study personnel. No de-identified individual participant data will be shared outside the primary research group.

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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