NCT07254910

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

May 30, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

October 28, 2025

Last Update Submit

April 22, 2026

Conditions

Keywords

colorectal screeningvirtual clinicianmulti-channel communicationtribal outreachTribal Nations

Outcome Measures

Primary Outcomes (1)

  • Reach

    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 Outcomes (2)

  • Potential efficacy

    From enrollment to the end of intervention at 30 days

  • FIT Kit Screening

    30 days

Study Arms (2)

Narrative Testimonial Video of a Tribal Community Health Educator

ACTIVE COMPARATOR

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

v-TCHE Interaction

ACTIVE COMPARATOR

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

Interventions

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.

Narrative Testimonial Video of a Tribal Community Health Educator

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.

v-TCHE Interaction

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jordan Neil, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Neil, PhD

CONTACT

Adam Alexander, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Phase 1: We will conduct 4 focus groups (n=6-8 per group) or individual interviews of AI patients from IHS Clinton Service Unit at the clinic or via Zoom. Groups will be stratified by past completion of previous FIT screening (yes/no) to compare perceived and structural barriers/facilitators to CRC screening. Intervention will be co-developed and employ value-centered design principles to tailor content to Cheyenne and Arapaho cultural norms. The CAB will be used to co-develop the focus group guides before use implementation with patients. Phase 2: The Tribal community health educator will be professionally recorded by the OU Health Marketing team to create Narrative Testimonial Video and v-TCHE interventions. The v-TCHE video will then be digitized to create a photorealistic v-TCHE will be created using the AI video generation system, Synethesia. Phase 3: Create a HIPAA-compliant, secure REDCap study database.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2025

First Posted

November 28, 2025

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations