Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04428736
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2020-05-22
Brief Title:
Evaluating Cascade Communication Methods
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
ECHO Evaluating Cascade Communication Methods
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHO
Brief Summary:
Hereditary cancer programs face challenges with respect to effective communication of genetic test results within families and uptake of genetic testing by relatives This study aims to determine if a disclosure toolkit provided to the index participant carrier of cancer risk gene mutation contributes to sharing genetic test results with relatives if there are preferred disclosure methods and whether toolkit use contributes towards at-risk relatives pursuing genetic testing
Detailed Description:
The identification of a single individual with a highly penetrant cancer susceptibility gene mutation can have far reaching implications for at-risk relatives in that other family members can engage in highly informative and predictive genetic testing for cancer predisposition Family members who carry the familial cancer gene mutation are able to receive personalized cancer risk management based upon their positive test result while those family members who test negative can generally be downgraded to follow cancer screening guidelines for the general population barring additional familial or personal risk factors for developing cancer Though crucial for stratifying and managing risks for relatives familial testing otherwise known as cascade testing is not always successfully implemented within and across families On a clinical basis the proband also known as the index mutation carrier is generally encouraged to share results with family members in order to promote their engagement in genetic counseling and testing Despite the provision of results and a tailored letter for family members hereditary cancer programs routinely face challenges with respect to communication of results within families and uptake of testing by relatives Research on family communication and cascade testing substantiates this experience as previous studies have demonstrated suboptimal uptake of cascade testing in families despite its importance for defining and managing cancer risk Barsevicket al2008 Daly et al 2016 The purpose of our research study is to determine whether the provision of multiple communication tools and platforms will improve communication between probands and at-risk relatives and if so which communication method is the most useful to probands in communicating their results and to relatives in coming to a decision regarding genetic counseling and testing Through the study probands will be provided with a three-part toolkit that includes a letter website and a chatbot known as GIA forGenetic Information Assistant Though the challengesbarriers of cascade testing are well-documented there are scant reports of follow-up with relatives Our study allows direct contact with family members by way of proband consent to assess motivations and barriers to genetic testing by family members
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None