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临床试验/NCT07254910
NCT07254910招募中不适用

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

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Reach

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Narrative Testimonial Video (Behavioral)

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.

干预措施: v-TCHE Interaction (Behavioral)

结局指标

主要结局

Reach

时间窗: 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.

次要结局

  • Potential efficacy(From enrollment to the end of intervention at 30 days)
  • FIT Kit Screening(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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