Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562778
• Other study ID #: 21-11024123
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Weill Medical College of Cornell University
• Contact: Melissa K Frey, MD, MS
• Phone: 212-746-3049
• Email: mkf2002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Hereditary Cancer Syndrome
• Neoplastic Syndromes, Hereditary

Intervention

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.

Locations

Country	Name	City	State
United States	NYP Brooklyn Methodist Hospital	Brooklyn	New York
United States	NYP Lower Manhattan Hospital	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	NYP Medical Group Queens	Queens	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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