MedDataX Logo

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

NCT ID: NCT07254910

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CRC Screening CRC (Colorectal Cancer)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

colorectal screening virtual clinician multi-channel communication tribal outreach Tribal Nations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Narrative Testimonial Video

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

v-TCHE Interaction

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jordan Neil, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jordan Neil, PhD

Role: CONTACT

Phone: (405) 271-5046

Email: [email protected]

Adam Alexander, PhD

Role: CONTACT

Phone: (405) 271-5046

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jan Foisy

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16811

Identifier Type: -

Identifier Source: org_study_id