Genetic Risk: Whether, When, and How to Tell Adolescents

Completed

• Conditions: Huntington Disease; Hereditary Breast and Ovarian Cancer; Hereditary Cancer; Hereditary Non-Polyposis Colorectal Cancer Syndrome; Hereditary Non-polyposis Colon Cancer

• Registration Number: NCT03421327
• Lead Sponsor: Johns Hopkins University

Brief Summary

This study is being conducted to learn more about family communication of genetic risk information. Semi-structured interviews lasting up to one hour will be conducted with three populations: parent/child pairs at risk for Huntington's Disease, parent/child pairs at risk for hereditary cancer, and genetic counselors.

Detailed Description

The investigators currently lack an adequate understanding of how parents and children feel about genetic risk/status, how it is communicated, and how it influences wellbeing and family relationships. This understanding is vital in order for genetic counselors and other health care professionals to provide the best guidance possible to families. However, little research has been conducted on the impact of genetic risk information or testing on children from the perspective of the child. The research proposed here is uniquely positioned to help fill this gap.

For this study, the investigators will interview 15-20 parent/child pairs who are at risk for Huntington's Disease (HD), 15-20 parent/child pairs who are at risk for hereditary cancer, and 15-20 certified genetic counselors. Interviews will last no more than one hour and will be conducted at a time and place that is convenient for the participant. The investigators will offer participants a choice of conducting the interview in a private conference room at the Berman Institute of Bioethics, or remotely by Skype or telephone. Parents and children will be interviewed separately. Parents will be asked about the decision process behind how and when they disclosed genetic information to their child, style of family communication, advice for other parents in similar situations, and other questions related to the subject of communication of genetic information to minors. Children will be asked about their experience learning genetic risk information, style of family communication, how they felt, advice for other kids in similar situations, and other questions related to the subject of communication of genetic information to minors.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Parents at-risk for HD, affected by HD, or be the spouse/partner of someone living who at risk for or affected by HD.
• Parents who have or have had a diagnosis of hereditary cancer, or the spouse/partner of someone living who has or has had had a diagnosis of hereditary cancer.
• Children ages 15-17 who are at risk for either HD or hereditary cancer

Exclusion Criteria

• Parents and children who have not yet communicated about genetic risk
• Children younger than age 15

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative analysis of how parents and children with either Huntington's Disease or hereditary cancer communicate about genetic risk information	1.5 years	Qualitative interview performed at one occasion where the patient describes when and how genetic risk information was disclosed to minor as well as perspectives from both parent and child.

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States