NCT04142333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 18, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

July 18, 2019

Last Update Submit

October 31, 2022

Conditions

Genetic Predisposition

Keywords

genetic counselinggenetic testing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Impact:To determine percentage of family members that use the GIA chatbox by assessing the number of times GIA was used

    1 year

Study Arms (1)

GIA Access

OTHER

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

Genetic: GIA

Interventions

GIAGENETIC

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.

GIA Access

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatient population will be pulled from Gynecologic Oncology Women's Clinic and High Risk Breast and Ovarian Cancer Clinic at UVA
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Undergoing genetic testing at UVA for a personal or family history of breast or gynecologic cancers in Cancer Genetics.

You may not qualify if:

  • Not receiving treatment at UVA
  • Not English literate
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related 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. Epub 2016 Jul 22.

    PMID: 27443514RESULT

  • 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.

    PMID: 22006311RESULT

Related Links

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 18, 2019

First Posted

October 29, 2019

Study Start

December 18, 2020

Primary Completion

August 9, 2021

Study Completion

December 1, 2022

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)