Clinical trial NCT05562778: Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment
Official title: Evaluation of a Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment in an Underserved Gynecology Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Hereditary Cancer Syndrome
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm randomized controlled trial of a chatbot for personal/family history intake vs. usual care (intake via the clinician interview). Enrolled patients will be randomized in a 1:1 ratio.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion recommended genetic testing
timeFrame: 2 years
Secondary outcomes:
measure: Proportion completed recommended genetic testing
timeFrame: 2 years
measure: Facilitator of inequity in the utilization of genetic services
timeFrame: 2 years
measure: Facilitator of inequity in the utilization of genetic services
timeFrame: 2 years
measure: Facilitator of inequity in the utilization of genetic services
timeFrame: 2 years
measure: Facilitator of inequity in the utilization of genetic services
timeFrame: 2 years
measure: Facilitator of inequity in the utilization of genetic services
timeFrame: 2 years
measure: Facilitator of inequity in the utilization of genetic services
timeFrame: 2 years
measure: Facilitator of inequity in the utilization of genetic services
timeFrame: 2 years
measure: Barriers to genetic testing
timeFrame: 2 years
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYP Brooklyn Methodist Hospital
state: New York
city: New York
country: United States
facility: NYP Lower Manhattan Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Queens
country: United States
facility: NYP Medical Group Queens
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Melissa K Frey, MD
role: PRINCIPAL_INVESTIGATOR
References: