Oral CancerNCT06682494
Enhancing Oral Cancer Awareness
A study testing Traditional Education and AI-powered Chatbox in people with Oral Cancer and Chatbot, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
To evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on increasing participants' knowledge of oral cancer and its prevention Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Chatbot, Patient Education
- What is being tested?
- Traditional Education and AI-powered Chatbox
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 31 Oct 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as African American as defined by the US Census
- Participants must be able to read, speak, and write in English
Who cannot join
- Individuals who cannot physically or mentally participate in the research project will be excluded
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Tamas Gal, Ph.D, 804-628-2123, Tamas.Gal@vcuhealth.org
Tamas Gal, Ph.D
About this study
Official title: Comparative Study on Enhancing Oral Cancer Awareness: Classical Educational Materials vs. AI-Powered Chatbot
To evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on increasing participants' knowledge of oral cancer and its prevention
Read the detailed description
The study evaluates the difference in outcome of two distinct interventions aimed at enhancing oral cancer awareness and prevention among participants from African American communities in the Richmond area. Participants assigned to the first intervention arm will receive traditional educational handouts sourced from trustworthy and reliable health sources such as the CDC, American Cancer Association (ACA), and other health education resources. These handouts will be provided to the participants and provided enough time to read them based on calculated reading time, focusing on increasing awareness of oral cancer risks, preventive strategies, and the importance of regular dental check-ups. Participants assigned to the second intervention arm will engage with an AI-powered chatbot designed specifically for oral cancer education. The chatbot interaction will be initiated through a provided link, allowing participants to access information and ask questions related to oral health and cancer prevention. The chatbot is programmed to provide accurate information on oral cancer risks, symptoms, preventive measures, and the importance of regular dental check-ups
- Conditions
- Oral Cancer, Chatbot, Patient Education, Prevention, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancers
- Being tested
- Traditional Education, AI-powered Chatbox
- Keywords
- AI-powered Chatbox, Oral cancer prevention, Socio-economic barriers
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional EducationBehavioural
Participants will receive traditional educational handouts focusing on increasing awareness of oral cancer risks, preventive strategies, and the importance of regular dental check-ups. Participants will be provided time to read the handouts based on calculated reading time.
AI-powered ChatboxBehavioural
The chatbot interaction will be initiated through a provided link, allowing participants to access information and ask questions related to oral health and cancer prevention. The chatbot is programmed to provide accurate information on oral cancer risks, symptoms, preventive measures, and the importance of regular dental check-ups. Participants will be encouraged to interact with the chatbot for a specified duration
| Study group | Role | What they receive |
|---|---|---|
| Traditional Educational Materials | Active comparator | Receiving oral cancer educational materials (handouts from trusted sources such as the Centers for Disease Control (CDC) and American Cancer Association (ACA) and other reliable health education resources. Receives: Behavioral: Traditional Education |
| Engaging with an AI-powered Chatbot | Experimental | AI-powered chatbox designed specifically for oral cancer education. The chatbot is programmed to provide accurate information on oral cancer risks, symptoms, preventive measures, and the importance of regular dental check-ups. Receives: Behavioral: AI-powered Chatbox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare participant retention rates between the AI-powered tool arm and the conventional educational material arm
Compare the percentage of participants that continued the intervention to the participants that continued using the active comparator to measure intervention feasibility.
Measured: Baseline, and post intervention (3 months)
Evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on knowledge and behavior
Assess the effectiveness of the interventions by baseline and post intervention surveys assessing oral cancer knowledge, attitudes, and behaviors utilizing a questionnaire based on the Health Belief Model.
The questionnaire will include scales measuring knowledge about oral cancer, its causes, risk factors, signs, preventive methods. Each question will have one correct answer, and the final score at baseline and after the intervention will be compared. Based on previous literature, a score of 60-70% can indicate adequate knowledge about a disease, but the primary goal of the outcome is to compare improvement in knowledge between control vs intervention arms.
Measured: Baseline, and post intervention (3 months)
Investigate socio-demographic factors that affect oral cancer knowledge in the African American population
Pre-intervention surveys will include questions assessing socio-demographic variables of the participants. These variables will serve as covariates in the analysis to measure their effects on knowledge and attitudes.
The effect of demographic factors affecting healthcare service utilization, such as education attainment and health insurance status, on knowledge about and attitude toward oral cancer will be measured through regression analysis to investigate their impact on oral cancer awareness and prevention efforts.
Measured: Baseline, and post intervention (3 months)
Evaluate the acceptability of AI-powered chatbot interactions versus traditional educational handouts
Assess the acceptability of the interventions by baseline and post intervention surveys assessing satisfaction, appropriateness, ease of use, and acceptability of the interventions to improve oral cancer knowledge.
Satisfaction and acceptability will be measured through a set of questions in the post-intervention questionnaire with 5 Likert scale-based responses ranging from "Strongly Disagree" to "Strongly Agree", and the final score will be compared between arms.
Measured: Baseline, and post intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start24 Sep 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for Cancer Education
- Responsible party
- Sponsor
- Investigators
- Tamas Gal, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682494
- Sponsor's protocol ID
- MCC-24-21890
- Other IDs
- HM20030494
- Status last verified
- May 2026
- First submitted
- 29 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant survey data dictionary and individual participant responses will be shared upon request. Requests will be submitted to the PI (Tamas Gal, PhD) through email (Tamas.Gal@vcuhealth.org)