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Recruiting NCT05562778

Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment

No phase Interventional Gynecologic Cancer Hereditary Cancer Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chatbot.
Who it may be relevant to
Registry conditions: Gynecologic Cancer, Hereditary Cancer Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 p

Primary outcome measures

  • Proportion recommended genetic testing [Time frame: 2 years]
Secondary outcome measures (9)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 4 centers
  • NYP Brooklyn Methodist Hospital — Brooklyn
  • NYP Lower Manhattan Hospital — New York
  • Weill Cornell Medicine — New York
  • NYP Medical Group Queens — Queens

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. PMID 39237276

Identifiers

NCT: NCT05562778 · 21-11024123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗