- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06682494
Enhancing Oral Cancer Awareness
Comparative Study on Enhancing Oral Cancer Awareness: Classical Educational Materials vs. AI-Powered Chatbot
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tamas Gal, Ph.D
- Phone Number: 804-628-2123
- Email: Tamas.Gal@vcuhealth.org
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Tamas Gal, Ph.D
- Phone Number: 804-628-2123
- Email: Tamas.Gal@vcuhealth.org
-
Principal Investigator:
- Tamas Gal, Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identify as African American as defined by the US Census
- Participants must be able to read, speak, and write in English
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Educational Materials
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.
|
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.
|
|
Experimental: Engaging with an AI-powered Chatbot
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare participant retention rates between the AI-powered tool arm and the conventional educational material arm
Time Frame: Baseline, and post intervention (3 months)
|
Compare the percentage of participants that continued the intervention to the participants that continued using the active comparator to measure intervention feasibility.
|
Baseline, and post intervention (3 months)
|
|
Evaluate the impact of AI-powered chatbot interactions versus traditional educational handouts on knowledge and behavior
Time Frame: Baseline, and post intervention (3 months)
|
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. |
Baseline, and post intervention (3 months)
|
|
Investigate socio-demographic factors that affect oral cancer knowledge in the African American population
Time Frame: Baseline, and post intervention (3 months)
|
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. |
Baseline, and post intervention (3 months)
|
|
Evaluate the acceptability of AI-powered chatbot interactions versus traditional educational handouts
Time Frame: Baseline, and post intervention (3 months)
|
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. |
Baseline, and post intervention (3 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tamas Gal, Ph.D, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Otorhinolaryngologic Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Pharyngeal Diseases
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Mouth Neoplasms
- Oropharyngeal Neoplasms
Other Study ID Numbers
- MCC-24-21890
- HM20030494 (Other Identifier: Virginia Commonwealth University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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