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Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment

Primary Purpose

Gynecologic Cancer, Hereditary Cancer Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chatbot
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gynecologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NYP Brooklyn Methodist Hospital
  • NYP Lower Manhattan Hospital
  • Weill Cornell MedicineRecruiting
  • NYP Medical Group Queens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chatbot

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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.
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.
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).
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).
Barriers to genetic testing
The barriers (as identified through qualitative interviews) to genetic testing among high-risk patients who decline recommended genetic testing.

Full Information

First Posted
September 27, 2022
Last Updated
September 29, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05562778
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Hereditary Cancer Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chatbot
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Chatbot
Intervention Description
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 Information:
Title
Proportion recommended genetic testing
Description
The proportion of high-risk patients that are recommended genetic testing for familial cancer syndromes in the chatbot vs. usual care arms.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion completed recommended genetic testing
Description
The proportion of high-risk patients who complete recommended genetic testing for familial cancer syndromes in the chatbot vs. usual care arms.
Time Frame
2 years
Title
Facilitator of inequity in the utilization of genetic services
Description
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.
Time Frame
2 years
Title
Facilitator of inequity in the utilization of genetic services
Description
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).
Time Frame
2 years
Title
Facilitator of inequity in the utilization of genetic services
Description
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.
Time Frame
2 years
Title
Facilitator of inequity in the utilization of genetic services
Description
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.
Time Frame
2 years
Title
Facilitator of inequity in the utilization of genetic services
Description
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.
Time Frame
2 years
Title
Facilitator of inequity in the utilization of genetic services
Description
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).
Time Frame
2 years
Title
Facilitator of inequity in the utilization of genetic services
Description
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).
Time Frame
2 years
Title
Barriers to genetic testing
Description
The barriers (as identified through qualitative interviews) to genetic testing among high-risk patients who decline recommended genetic testing.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa K Frey, MD, MS
Phone
212-746-3049
Email
mkf2002@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Chandler
Phone
212-746-3049
Email
irc4005@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa K Frey, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYP Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Howard, MD, MPH
Phone
718-362-3260
First Name & Middle Initial & Last Name & Degree
Michael Kim, MD
Phone
718-362-3260
First Name & Middle Initial & Last Name & Degree
Denise Howard, MD, MPH
Facility Name
NYP Lower Manhattan Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Cron, MD, FACOG
Phone
646-962-2620
First Name & Middle Initial & Last Name & Degree
Julia Cron, MD, FACOG
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa K Frey, MD, MS
Phone
212-746-3049
Email
mkf2002@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Isabelle Chandler
Phone
212-746-3049
Email
irc4005@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Melissa K Frey, MD
Facility Name
NYP Medical Group Queens
City
Queens
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Fishman, MD
Phone
718-670-1731
First Name & Middle Initial & Last Name & Degree
David Fishman, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment

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