GIA in Cascade Testing

Study Overview
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Brief Summary
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The objective of this pilot study is to evaluate the feasibility and acceptability of GIA in sharing genetic test results with family members. To determine the utility of GIA in sharing information. To determine the impact of GIA on downstream cascade testing rates.

Detailed Description
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Chatbots, also known as conversation agents, are programs designed to have interactive conversations with humans. While traditionally used in sectors such as online gaming and customer service, chatbots have made their way into a number of industries including healthcare and have shown promise in areas such as managing anxiety/depression, weight loss, and medication adherence. GIA (Genetic Information Assistant) is a chatbot specifically designed as a tool for patients to use for disseminating genetic results, education, and genetic counseling resources to their family members after they themselves receive a positive result. Patients receive a secure GIA link from their provider and then are able to send their relatives the link to GIA through texting, email, and/or Facebook messenger. Once a relative clicks on the provided link, GIA's platform is structured as a decision tree, allowing family members to construct a personalized conversation about their family member's test results. This can be done either on a smartphone or computer. GIA provides basic genetics education and risk assessment and connects family members with local genetic counseling resources to continue this conversation and/or go forward with genetic testing. At the end of the conversation, the family member has the option of having a transcript sent to them via email for their reference. The objective of the current study is to evaluate the application of GIA for cascade testing in newly identified high risk breast and gynecologic mutation carriers.

Official Title
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GIA in Cascade Testing

Conditions
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Genetic Predisposition

Intervention / Treatment
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* Genetic: GIA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Undergoing genetic testing at UVA for a personal or family history of breast or gynecologic cancers in Cancer Genetics. Exclusion Criteria: Not receiving treatment at UVA Not English literate Unable to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GIA Access<br>All patients consented to this study will be given access to the GIA technology to share with their family members. | Genetic: GIA<br>* Patients receive a secure GIA link from their provider and then are able to send their relatives the link to GIA through texting, email, and/or Facebook messenger. Once a relative clicks on the provided link, GIA's platform is structured as a decision tree, allowing family members to construct a personalized conversation about their family member's test results. This can be done either on a smartphone or computer. GIA provides basic genetics education and risk assessment and connects family members with local genetic counseling resources to continue this conversation and/or go forward with genetic testing. At the end of the conversation, the family member has the option of having a transcript sent to them via email for their reference. The objective of the current study is to evaluate the application of GIA for cascade testing in newly identified high risk breast and gynecologic mutation carriers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility: Determine percentage of patients that report GIA, the Genetic Information Assistant chatbox, is an acceptable form of family disclosure | Participants will complete a survey regarding the acceptability of GIA for use in disclosing results to family members. Feasibility will be assessed by tracking the number of family members contacted through GIA, the number of family members who access/interact with GIA, and the content topics most frequently covered in family member conversations. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact:To determine percentage of family members that use the GIA chatbox by assessing the number of times GIA was used | Participants will complete a survey regarding the acceptability of GIA for use in disclosing results to family members. Feasibility will be assessed by tracking the number of family members contacted through GIA, the number of family members who access/interact with GIA, and the content topics most frequently covered in family member conversations. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic counseling, genetic testing