Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment

Evaluation of a Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment in an Underserved Gynecology Population

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Hereditary Cancer Syndrome
• Intervention / Treatment: Other: Chatbot

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa K Frey, MD, MS; Phone Number: 212-746-3049; Email: mkf2002@med.cornell.edu
• Study Contact Backup: Name: Isabelle Chandler; Phone Number: 212-746-3049; Email: irc4005@med.cornell.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • Not yet recruiting
      • NYP Brooklyn Methodist Hospital
      • Contact: Denise Howard, MD, MPH; Phone Number: 718-362-3260
      • Contact: Michael Kim, MD; Phone Number: 718-362-3260
      • Principal Investigator: Denise Howard, MD, MPH
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Principal Investigator: Melissa K Frey, MD
      • Contact: Melissa K Frey, MD, MS; Phone Number: 212-746-3049; Email: mkf2002@med.cornell.edu
      • Contact: Isabelle Chandler; Phone Number: 212-746-3049; Email: irc4005@med.cornell.edu
    • New York, New York, United States, 10038
      • Not yet recruiting
      • NYP Lower Manhattan Hospital
      • Contact: Julia Cron, MD, FACOG; Phone Number: 646-962-2620
      • Principal Investigator: Julia Cron, MD, FACOG
    • Queens, New York, United States, 11375
      • Not yet recruiting
      • NYP Medical Group Queens
      • Contact: David Fishman, MD; Phone Number: 718-670-1731
      • Principal Investigator: David Fishman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	2 years
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).	2 years
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.	2 years
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 Decision Scale will enable these patients to identify various facilitators that influenced their decision not to complete genetic testing. Specifically, the Satisfaction with Decision Scale will assess a patient's satisfaction with their decision to undergo genetic testing using 6 statements that a patient must agree or disagree with, scaled from strongly agree to strongly disagree.	2 years
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 Feelings about Genomic Testing Results (FACToR) survey Scale will enable these patients to identify various facilitators that influenced their decision not to complete genetic testing. Specifically, the Feelings about Genomic Testing Results (FACToR) survey asks 12 questions regarding how the patient felt after they received their genetic results, indicating within the past week if they had the specific feeling: not at all, a little, somewhat, a good deal, or a great deal.	2 years
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 Perceptions of Uncertainties in Genomic Sequencing (PUGS) survey will enable these patients to identify various facilitators that influenced their decision not to complete genetic testing. Specifically, the Perceptions of Uncertainties in Genomic Sequencing (PUGS) survey assesses patient's certainty about 8 aspects of their genetic testing, from 1 (very uncertain) to 5 (very certain).	2 years
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 Patient Reported Utility (PrU) survey will enable these patients to identify various facilitators that influenced their decision not to complete genetic testing. Specifically, the Patient Reported Utility (PrU) that assesses how useful patients found certain outcomes of their test results, ranking from 1 (not at all useful) to 7 (extremely useful).	2 years
Barriers to genetic testing	The barriers (as identified through qualitative interviews) to genetic testing among high-risk patients who decline recommended genetic testing.	2 years

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Melissa K Frey, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary
• Other Study ID Numbers: 21-11024123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No