Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05562778
Status
Recruiting
Apply to this trial

Conditions

  • Gynecologic Cancer
  • Hereditary Cancer Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Chatbot — OTHER
    A 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Chatbot
    Subjects will receive a text message initiating a chatbot conversation that relies on natural language processing to gather personal and family cancer. Subjects are identified by the chatbot as meeting National Comprehensive Cancer Network (NCCN) high-risk criteria. Next, subjects undergo pre-test genetic counseling via the chatbot and then clinicians are notified (via the chatbot portal) that the subject meets high-risk criteria. For subjects meeting high-risk criteria (based on the chatbot evaluation), the clinician will complete genetic counseling and recommend genetic testing during the visit. For subjects interested in genetic testing, the clinician will order genetic testing.
  • No Intervention: Usual Care
    Personal and family cancer history will be collected by the clinician during the subject's visit. Clinicians will evaluate the patient's personal/family history according to National Comprehensive Cancer Network (NCCN) high-risk criteria. For subjects recognized by the clinician as meeting NCCN criteria, the clinician will complete genetic counseling and recommend genetic testing. For subjects interested in genetic testing, the clinician will order genetic testing.

Primary Outcome Measure

Proportion recommended genetic testing [ Time Frame: 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
NYP Brooklyn Methodist HospitalBrooklynNew York11215
Denise Howard, MD, MPH
718-362-3260
Michael Kim, MD
718-362-3260
Denise Howard, MD, MPH (PRINCIPAL_INVESTIGATOR)
NYP Lower Manhattan HospitalNew YorkNew York10038
Julia Cron, MD, FACOG
646-962-2620
Julia Cron, MD, FACOG (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Melissa K Frey, MD, MS
[email protected]
212-746-3049
Isabelle Chandler
[email protected]
212-746-3049
Melissa K Frey, MD (PRINCIPAL_INVESTIGATOR)
NYP Medical Group QueensQueensNew York11375
David Fishman, MD
718-670-1731
David Fishman, MD (PRINCIPAL_INVESTIGATOR)

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