Recruiting

Chatbot vs. Usual Care

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05562778

Conditions

Gynecologic Cancer

Hereditary Cancer Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Chatbot

Study Details

Brief summary:

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.

Conditions

Gynecologic Cancer

Hereditary Cancer Syndrome

Study ID

NCT05562778

Start date

Jan 15, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Chatbot

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.

Primary outcome measure

  • Proportion recommended genetic testing [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Melissa K Frey, MD, MS

212-746-3049mkf2002@med.cornell.edu

Elise Barrow, MPH

ecb4001@med.cornell.edu

Locations

NYP Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Contacts

Denise Howard, MD, MPH

718-362-3260

Michael Kim, MD

718-362-3260

Principal Investigator:

Denise Howard, MD, MPH

NYP Lower Manhattan Hospital

Recruiting

New York, New York, United States, 10038

Contacts

Julia Cron, MD, FACOG

646-962-2620

Principal Investigator:

Julia Cron, MD, FACOG

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Melissa K Frey, MD, MS

212-746-3049mkf2002@med.cornell.edu

Elise C Barrow

6469247879ecb4001@med.cornell.edu

Principal Investigator:

Melissa K Frey, MD

NYP Medical Group Queens

Recruiting

Queens, New York, United States, 11375

Contacts

David Fishman, MD

718-670-1731

Principal Investigator:

David Fishman, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-23.