GIA in Cascade Testing

NCT ID: NCT04142333

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2022-12-01

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.

Conditions

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Genetic Predisposition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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GIA Access

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

Group Type OTHER

GIA

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type GENETIC

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Kari Ring, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27443514 (View on PubMed)

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.

Reference Type RESULT
PMID: 22006311 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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http://www.sgo.org/clinical-practice/guidelines/screening-for-lynch-syndrome-in-endometrial-cancer/

SGO Clinical Practice Statement: Screening for Lynch Syndrome in Endometrial Cancer

http://www.sgo.org/clinical-practice/guidelines/genetic-testing-for-ovarian-cancer/

SGO Clinical Practice Statement: Genetic Testing for Ovarian Cancer

Other Identifiers

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21168

Identifier Type: -

Identifier Source: org_study_id

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