GIA in Cascade Testing

Genetic Predisposition Clinical Trial

— GIA  

Official title:

GIA in Cascade Testing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04142333
• Other study ID #: 21168
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Genetic:
• GIA
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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ring KL, Bruegl AS, Allen BA, Elkin EP, Singh N, Hartman AR, Daniels MS, Broaddus RR. Germline multi-gene hereditary cancer panel testing in an unselected endometrial cancer cohort. Mod Pathol. 2016 Nov;29(11):1381-1389. doi: 10.1038/modpathol.2016.135. E — View Citation

Walsh T, Casadei S, Lee MK, Pennil CC, Nord AS, Thornton AM, Roeb W, Agnew KJ, Stray SM, Wickramanayake A, Norquist B, Pennington KP, Garcia RL, King MC, Swisher EM. Mutations in 12 genes for inherited ovarian, fallopian tube, and peritoneal carcinoma ide — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   SGO Clinical Practice Statement: Genetic Testing for Ovarian Cancer
•   SGO Clinical Practice Statement: Screening for Lynch Syndrome in Endometrial Cancer