Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
In this study, the investigators aim to compare a mobile health platform, known as a 'chatbot,' that leverages artificial intelligence and natural language processing to scale communication, to 'usual care' that patients would receive. This comparison will enable the investigators to determine if the chatbot system can improve rates of recommendation for genetic testing among patients at elevated risk of harboring a familial cancer syndrome in an all-Medicaid gynecology clinic. Furthermore, the investigators aim to evaluate facilitators of inequity in regard to patient access to and utilization of genetic testing services.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
8 years of age or older.
Scheduled for a New Patient appointment in the gynecology clinic. Speaks and reads in English.
Access to a telephone with texting capacity.
Has not had prior genetic testing for hereditary cancer syndromes.
Disqualifiers
Under 18 years of age
Has had previous genetic testing for hereditary cancer syndromes
Does not read/speak in English
Does not have access to a phone with texting capabilities
Trial design
Design model
Parallel
Treatments tested in this trial
Chatbot
Other interventionA chatbot is a software program designed to simulate human conversation, typically via text. Chatbots utilize natural language processing to gather patient data, anticipate questions, and predict responses. In this study, the Chatbot will simulate a text-like conversation with patients via a smartphone and use this platform to deal with the time-consuming nature of family history collection. The chatbots can then triage the collected family history against medical guidelines to determine which patients warrant genetic testing. For those patients meeting criteria for genetic testing, the chatbot can offer pre-test education and assist physicians with ordering genetic testing for interested patients meeting high-risk criteria.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: ChatbotExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion recommended genetic testing
The proportion of high-risk patients that are recommended genetic testing for familial cancer syndromes in the chatbot vs. usual care arms.
Time frame
2 yearsSecondary outcomes
1
Proportion completed recommended genetic testing
The proportion of high-risk patients who complete recommended genetic testing for familial cancer syndromes in the chatbot vs. usual care arms.
Time frame
2 years2
HADS Scale - Facilitator of inequity in the utilization of genetic services
The specific facilitators of inequity that affect the utilization of genetic testing services, among high-risk patients who decline recommended genetic testing. Examples of these facilitators include patient race, ethnicity, education, affordability, and social determinants of health. The validated survey known as the Hospital Anxiety and Depression Scale (HADS) will enable these patients to identify various facilitators that influenced their decision not to complete genetic testing. Specifically, the HADS survey has 7 questions each to assess depression and anxiety subscales. Scoring for each item ranges from 0 to 3, with 3 denoting highest anxiety or depression level, and 0 denoting the lowest. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Time frame
2 years3
NCCN Distress Thermometer - Facilitator of inequity in the utilization of genetic services
The specific facilitators of inequity that affect the utilization of genetic testing services, among high-risk patients who decline recommended genetic testing. Examples of these facilitators include patient race, ethnicity, education, affordability, and social determinants of health. The validated survey known as the NCCN Distress Thermometer will enable these patients to identify various facilitators that influenced their decision not to complete genetic testing. Specifically, the NCCN Distress Thermometer allows patients to self report how much distress they have been experiencing in the past week on a scale from 0 (no distress) to 10 (extreme distress).
Time frame
2 years4
Pt. Satisfaction - Facilitator of inequity in the utilization of genetic services
The specific facilitators of inequity that affect the utilization of genetic testing services, among high-risk patients who decline recommended genetic testing. Examples of these facilitators include patient race, ethnicity, affordability, and social determinants of health. The validated survey known as the Satisfaction with genetic assessment will enable these patients to identify various facilitators that influenced their decision not to complete genetic testing. Specifically, the Satisfaction with genetic assessment includes the review of a patient's personal and family history with regards to cancer that was performed by the medical provider during the patient's Gynecology New Patient Visit. This is scaled from strongly agree to strongly disagree.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov