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

NCT03421327 | Completed

• 2 other identifiers: IRB00121662R01HG008045
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Qualitative analysis of how parents and children with either Huntington's Disease or hereditary cancer communicate about genetic risk information

  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.

  1.5 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include individuals who reside in the USA, speak English, and are able to participate in one interview either in person, via phone, or via Skype.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Related Publications (13)

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  PMID: 17361007 BACKGROUND

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  PMID: 9497246 BACKGROUND

• McConkie-Rosell A, Spiridigliozzi GA, Melvin E, Dawson DV, Lachiewicz AM. Living with genetic risk: effect on adolescent self-concept. Am J Med Genet C Semin Med Genet. 2008 Feb 15;148C(1):56-69. doi: 10.1002/ajmg.c.30161.

  PMID: 18200514 BACKGROUND

• Hamilton RJ. Using skype to conduct interviews for psychosocial research. Comput Inform Nurs. 2014 Aug;32(8):353-8. doi: 10.1097/CIN.0000000000000095. No abstract available.

  PMID: 25133565 BACKGROUND

• Janghorban R, Latifnejad Roudsari R, Taghipour A. Skype interviewing: the new generation of online synchronous interview in qualitative research. Int J Qual Stud Health Well-being. 2014 Apr 15;9:24152. doi: 10.3402/qhw.v9.24152. eCollection 2014.

  PMID: 24746247 BACKGROUND

• Meropol NJ, Daly MB, Vig HS, Manion FJ, Manne SL, Mazar C, Murphy C, Solarino N, Zubarev V. Delivery of Internet-based cancer genetic counselling services to patients' homes: a feasibility study. J Telemed Telecare. 2011;17(1):36-40. doi: 10.1258/jtt.2010.100116. Epub 2010 Nov 19.

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• Abdolahi A, Bull MT, Darwin KC, Venkataraman V, Grana MJ, Dorsey ER, Biglan KM. A feasibility study of conducting the Montreal Cognitive Assessment remotely in individuals with movement disorders. Health Informatics J. 2016 Jun;22(2):304-11. doi: 10.1177/1460458214556373. Epub 2014 Nov 11.

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  PMID: 25359404 BACKGROUND

MeSH Terms

Conditions

Huntington Disease; Hereditary Breast and Ovarian Cancer Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Debra Mathews, PhD, MA

  Johns Hopkins Berman Institute of Bioeithics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: February 5, 2018
• Study Start: September 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)