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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT03421327

Collaborator

National Human Genome Research Institute (NHGRI) (NIH)

Enrollment

Location

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Huntington Disease Hereditary Breast and Ovarian Cancer Hereditary Cancer Hereditary Non-polyposis Colon Cancer Hereditary Non-Polyposis Colorectal Cancer Syndrome

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 Design

Study Type:

Observational

Actual Enrollment :

85 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Families at-risk for HD No interventions will be administered. Participation involves one semi-structured interview that will last up to one hour. The interview will be scheduled at a time and place that is convenient for the participant. The participant will be given the option to conduct the interview via phone, Skype, or in-person at Johns Hopkins.
Families at-risk for hereditary cancer No interventions will be administered. Participation involves one semi-structured interview that will last up to one hour. The interview will be scheduled at a time and place that is convenient for the participant. The participant will be given the option to conduct the interview via phone, Skype, or in-person at Johns Hopkins.
Genetic Counselors No interventions will be administered. Participation involves one semi-structured interview that will last up to one hour. The interview will be scheduled at a time and place that is convenient for the participant. The participant will be given the option to conduct the interview via phone, Skype, or in-person at Johns Hopkins.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

Johns Hopkins University
National Human Genome Research Institute (NHGRI)

Investigators

Principal Investigator: Debra Mathews, PhD, MA, Johns Hopkins Berman Institute of Bioeithics

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT03421327

Other Study ID Numbers:

IRB00121662
R01HG008045

First Posted:

Feb 5, 2018

Last Update Posted:

Feb 7, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hereditary Breast and Ovarian Cancer Syndrome

Colorectal Neoplasms, Hereditary Nonpolyposis

Huntington Disease

Study Results

No Results Posted as of Feb 7, 2019