Gynecologic Cancer, Hereditary Cancer Syndrome
Conditions
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.
Interventions
OTHERChatbot
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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion recommended genetic testing | 2 years | The proportion of high-risk patients that are recommended genetic testing for familial cancer syndromes in the chatbot vs. usual care arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion completed recommended genetic testing | 2 years | 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 | 2 years | 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. |
| Barriers to genetic testing | 2 years | The barriers (as identified through qualitative interviews) to genetic testing among high-risk patients who decline recommended genetic testing. |
Countries
United States
Contacts
Primary ContactMelissa K Frey, MD, MS
Backup ContactIsabelle Chandler
Outcome results
None listed