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GIA in Cascade Testing (GIA)

Primary Purpose

Genetic Predisposition

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GIA
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Genetic Predisposition focused on measuring genetic counseling, genetic testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GIA Access

Arm Description

All patients consented to this study will be given access to the GIA technology to share with their family members.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 18, 2019
Last Updated
October 31, 2022
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04142333
Brief Title
GIA in Cascade Testing
Acronym
GIA
Official Title
GIA in Cascade Testing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
August 9, 2021 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Predisposition
Keywords
genetic counseling, genetic testing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GIA Access
Arm Type
Other
Arm Description
All patients consented to this study will be given access to the GIA technology to share with their family members.
Intervention Type
Genetic
Intervention Name(s)
GIA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Utility: Determine percentage of patients that report "GIA", the Genetic Information Assistant chatbox, is an acceptable form of family disclosure
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Impact:To determine percentage of family members that use the GIA chatbox by assessing the number of times GIA was used
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patient population will be pulled from Gynecologic Oncology Women's Clinic and High Risk Breast and Ovarian Cancer Clinic at UVA
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27443514
Citation
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. Epub 2016 Jul 22.
Results Reference
result
PubMed Identifier
22006311
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 identified by massively parallel sequencing. Proc Natl Acad Sci U S A. 2011 Nov 1;108(44):18032-7. doi: 10.1073/pnas.1115052108. Epub 2011 Oct 17.
Results Reference
result
Links:
URL
http://www.sgo.org/clinical-practice/guidelines/screening-for-lynch-syndrome-in-endometrial-cancer/
Description
SGO Clinical Practice Statement: Screening for Lynch Syndrome in Endometrial Cancer
URL
http://www.sgo.org/clinical-practice/guidelines/genetic-testing-for-ovarian-cancer/
Description
SGO Clinical Practice Statement: Genetic Testing for Ovarian Cancer

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GIA in Cascade Testing

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