Colorectal CancerNCT04705363
A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans
A study testing High Dialectal, Low Dialectal and Non-Dialectal in people with Colorectal Cancer, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- High Dialectal, Low Dialectal and Non-Dialectal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 751 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out of guidelines for colorectal cancer screening
- No fecal immunochemical test within the last 12 months
- No colonoscopy within the last ten years)
Who cannot join
- Must meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- High Dialectal, Low Dialectal, Non-Dialectal, Text-only
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High DialectalBehavioural
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction.
Low DialectalBehavioural
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction.
Non-DialectalBehavioural
A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction.
Text-onlyBehavioural
A virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text.
| Study group | Role | What they receive |
|---|---|---|
| Text-only | Active comparator | A virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text. Receives: Behavioral: Text-only |
| High Dialectal | Experimental | A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction. Receives: Behavioral: High Dialectal |
| Low Dialectal | Experimental | A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction. Receives: Behavioral: Low Dialectal |
| Non-Dialectal | Experimental | A virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction. Receives: Behavioral: Non-Dialectal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to Talk to Doctor About Colorectal Cancer Screening
Measure: Intention to talk to a doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: The virtual appointment made me want to discuss colon cancer screening options with my doctor.
Participants will respond using three 5-point Likert scales that will be summed. The total score ranges from 3 to 15, with higher scores indicating a greater intention to discuss colorectal cancer screening with a healthcare professional. Mean scores closer to 3 reflect lower intention, while mean scores closer to 15 reflect higher intention.
Measured: Immediately after the intervention, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start29 Jun 2021
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 4-arm randomized experimental message design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Janice Krieger, PhD, Principal investigator, Mayo Clinic of JacksonvilleKevin Tang, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705363
- Sponsor's protocol ID
- IRB202001790-N
- Other IDs
- UL1TR001427
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2021
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sociolinguistic-enabled Web Application to Develop Precision Health Intervention for African Americans
- ClinicalTrials.gov ID
- NCT04705363
- Acronym / sponsor ID
- IRB202001790-N
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- A 4-arm randomized experimental message design.
| Arm | Type | Receives |
|---|---|---|
| Text-only | Active comparator | Behavioral: Text-onlyA virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text. |
| High Dialectal | Experimental | Behavioral: High DialectalA virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction. |
| Low Dialectal | Experimental | Behavioral: Low DialectalA virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction. |
| Non-Dialectal | Experimental | Behavioral: Non-DialectalA virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Out of guidelines for colorectal cancer screening
- No fecal immunochemical test within the last 12 months
- No colonoscopy within the last ten years)
Key exclusion criteria (1 listed)
- Must meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High DialectalA virtual health assistant that will consist of an interactive computer-generated doctor with voice that used high dialectal variation that will guide participants through the interaction. | Behavioural | High Dialectal |
| Low DialectalA virtual health assistant that will consist of an interactive computer-generated doctor with voice that used low dialectal variation that will guide participants through the interaction. | Behavioural | Low Dialectal |
| Non-DialectalA virtual health assistant that will consist of an interactive computer-generated doctor with voice that used no dialectal variation that will guide participants through the interaction. | Behavioural | Non-Dialectal |
| Text-onlyA virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide participants through the interaction. No voice will accompany the photos or text. | Behavioural | Text-only |
Primary outcome
Intention to Talk to Doctor About Colorectal Cancer Screening
Time frame: Immediately after the intervention, up to 1 hour
Measure: Intention to talk to a doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: The virtual appointment made me want to discuss colon cancer screening options with my doctor. Participants will respond using three 5-point Likert scales that will be summed. The total score ranges from 3 to 15, with higher scores indicating a greater intention to discuss colorectal cancer screening with a healthcare professional. Mean scores closer to 3 reflect lower intention, while mean scores closer to 15 reflect higher intention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Krieger, PhD principal investigator
Mayo Clinic of Jacksonville
Kevin Tang, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dialectal, Low Dialectal and Non-Dialectal in people with Colorectal Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to Talk to Doctor About Colorectal Cancer Screening (time frame: Immediately after the intervention, up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.