Gynecologic CancerNCT05562778
Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment
A study testing Chatbot in people with Gynecologic Cancer and Hereditary Cancer Syndrome, run by Weill Medical College of Cornell University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Hereditary Cancer Syndrome
- What is being tested?
- Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jan 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Elise Barrow, MPH contact
United States4 sites, 4 recruiting
- Recruiting
NYP Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Denise Howard, MD, MPH, 718-362-3260
Michael Kim, MD, 718-362-3260
- Recruiting
NYP Lower Manhattan Hospital
New York, New York, 10038
Julia Cron, MD, FACOG, 646-962-2620
Julia Cron, MD, FACOG
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Melissa K Frey, MD, MS, 212-746-3049, mkf2002@med.cornell.edu
Elise C Barrow, 6469247879, ecb4001@med.cornell.edu
- Recruiting
NYP Medical Group Queens
Queens, New York, 11375
David Fishman, MD, 718-670-1731
David Fishman, MD
About this study
Official title: 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.
- Conditions
- Gynecologic Cancer, Hereditary Cancer Syndrome
- Being tested
- Chatbot
- Medical subject headings
- Neoplastic Syndromes, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot | Experimental | 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. Receives: Other: Chatbot |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (9)
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.
Measured: 2 years
HADS Scale - 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.
Measured: 2 years
NCCN Distress Thermometer - 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).
Measured: 2 years
Pt. Satisfaction - 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.
Measured: 2 years
Decision Satisfaction Scale - 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.
Measured: 2 years
FACTOR Scale - 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.
Measured: 2 years
PUGS Survey - 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).
Measured: 2 years
PRU Survey - 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).
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start15 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa K Frey, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562778
- Sponsor's protocol ID
- 21-11024123
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bull LE, Webster EM, McDougale A, Howard D, Ahsan MD, Levi S, Grant B, Chandler I, Christos P, Sharaf RN, Frey MK. Protocol for Health Risk Information Technology-Assisted Genetic Evaluation (HeRITAGE): a randomised controlled trial of digital genetic cancer risk assessment in a diverse underserved gynaecology clinic. BMJ Open. 2024 Sep 5;14(9):e082658. doi: 10.1136/bmjopen-2023-082658.
PubMed 39237276
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment in an Underserved Gynecology Population
- ClinicalTrials.gov ID
- NCT05562778
- Acronym / sponsor ID
- 21-11024123
- Conditions
- Gynecologic Cancer, Hereditary Cancer Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chatbot | Experimental | Other: ChatbotSubjects 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatbotA 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. | Other | Chatbot |
Primary outcome
Proportion recommended genetic testing
Time frame: 2 years
The proportion of high-risk patients that are recommended genetic testing for familial cancer syndromes in the chatbot vs. usual care arms.
9 secondary outcomes
Proportion completed recommended genetic testing
Time frame: 2 years
HADS Scale - Facilitator of inequity in the utilization of genetic services
Time frame: 2 years
NCCN Distress Thermometer - Facilitator of inequity in the utilization of genetic services
Time frame: 2 years
Pt. Satisfaction - Facilitator of inequity in the utilization of genetic services
Time frame: 2 years
Decision Satisfaction Scale - Facilitator of inequity in the utilization of genetic services
Time frame: 2 years
FACTOR Scale - Facilitator of inequity in the utilization of genetic services
Time frame: 2 years
PUGS Survey - Facilitator of inequity in the utilization of genetic services
Time frame: 2 years
PRU Survey - Facilitator of inequity in the utilization of genetic services
Time frame: 2 years
Barriers to genetic testing
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 39237276Bull LE, Webster EM, McDougale A, Howard D, Ahsan MD, Levi S, Grant B, Chandler I, Christos P, Sharaf RN, Frey MK. Protocol for Health Risk Information Technology-Assisted Genetic Evaluation (HeRITAGE): a randomised controlled trial of digital genetic cancer risk assessment in a diverse underserved gynaecology clinic. BMJ Open. 2024 Sep 5;14(9):e082658. doi: 10.1136/bmjopen-2023-082658.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elise Barrow, MPH contact
Melissa K Frey, MD principal investigator
Weill Medical College of Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot in people with Gynecologic Cancer and Hereditary Cancer Syndrome, run by Weill Medical College of Cornell University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa K Frey, MD, MS (212-746-3049, mkf2002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion recommended genetic testing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.