Clinical trial NCT04705363: A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans
Official title: A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-01-12
Enrollment: 751
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 4-arm randomized experimental message design.
Primary purpose: SCREENING

Brief summary: This pilot study will explore the preliminary efficacy of a colorectal cancer (CRC) screening intervention delivered by Virtual Human Agents (VHAs). Seven hundred fifty participants aged 45 to 75 will be recruited through Qualtrics panels. The study examines how different levels of dialectal linguistic features willingness to be screened for colorectal cancer. Participants will be randomly assigned to interact with one of four VHA conditions: a VHA using non-dialectal linguistic features, a VHA with a low level of dialectal linguistic features integrated, a VHA with a high level of dialectal linguistic features integrated, or a text-only control condition. Following the interaction, participants will complete survey measures to assess perceived willingness to be screened.

Detailed description: African Americans experience significant health inequities, including higher morbidity and mortality rates due to colorectal cancer (CRC) compared to White Americans. While the causes of these disparities are complex, regular screening can help reduce them. However, adherence to CRC screening guidelines remains low, particularly among African Americans.

One strategy to reduce CRC screening disparities is using strategic communication interventions to promote the fecal immunochemical test (FIT). FIT is a low-cost, non-invasive screening method that alleviates common patient barriers to CRC screening and is as effective as colonoscopy in reducing CRC incidence and mortality.

Tailored messaging interventions have been shown to improve CRC screening rates. However, two critical questions must be addressed before implementing tailored screening interventions within healthcare systems: (1) To what extent must message content be tailored to be effective? and (2) How can participants be effectively engaged?

This study builds upon an existing project that utilizes mobile Virtual Human Technology (VHT) to deliver tailored CRC screening messages. Virtual Human Agents (VHAs) provide a unique opportunity to customize communication strategies, including linguistic adaptation, to align with patient preferences. Such interventions can help mitigate CRC screening barriers such as cultural mismatch and low self-efficacy.

This study investigates explicitly the role of dialectal linguistic features in shaping willingness to be screened for CRC. The pilot study is exploratory in nature and seeks to examine the following aim: To assess how tailoring the dialectal variety of VHA speech affects willingness to be screened for CRC.

We aim to recruit 750 participants, each of whom will interact with a VHA that varies in speech style across four conditions: (1) non-dialectal linguistic features, (2) a low-level integration of dialectal linguistic features, (3) a high-level integration of dialectal linguistic features, or (4) a voiceless, text-only control. Following the interaction, participants will assess the VHA's credibility using survey-based measures.

Eligibility criteria: Inclusion Criteria:

* Out of guidelines for colorectal cancer screening
* No fecal immunochemical test within the last 12 months
* No colonoscopy within the last ten years)

Exclusion Criteria:

* Must meet inclusion criteria

Primary outcomes:
measure: Intention to Talk to Doctor About Colorectal Cancer Screening
timeFrame: Immediately after the intervention, up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Qualtrics
state: Florida
Study officials:
affiliation: Mayo Clinic of Jacksonville
name: Janice Krieger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Kevin Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: