Huntington Disease Clinical Trial
Official title:
Genetic Risk: Whether, When, and How to Tell Adolescents
Verified date | February 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Human Genome Research Institute (NHGRI) |
United States,
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. — View Citation
Appelbaum PS, Parens E, Waldman CR, Klitzman R, Fyer A, Martinez J, Price WN 2nd, Chung WK. Models of consent to return of incidental findings in genomic research. Hastings Cent Rep. 2014 Jul-Aug;44(4):22-32. doi: 10.1002/hast.328. Epub 2014 Jun 11. — View Citation
Ford D, Easton DF, Stratton M, Narod S, Goldgar D, Devilee P, Bishop DT, Weber B, Lenoir G, Chang-Claude J, Sobol H, Teare MD, Struewing J, Arason A, Scherneck S, Peto J, Rebbeck TR, Tonin P, Neuhausen S, Barkardottir R, Eyfjord J, Lynch H, Ponder BA, Gayther SA, Zelada-Hedman M, et al. Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families. The Breast Cancer Linkage Consortium. Am J Hum Genet. 1998 Mar;62(3):676-89. — View Citation
Garber JE, Offit K. Hereditary cancer predisposition syndromes. J Clin Oncol. 2005 Jan 10;23(2):276-92. Review. — View Citation
Hamilton RJ. Using skype to conduct interviews for psychosocial research. Comput Inform Nurs. 2014 Aug;32(8):353-8. doi: 10.1097/CIN.0000000000000095. — View Citation
Hilgart JS, Hayward JA, Coles B, Iredale R. Telegenetics: a systematic review of telemedicine in genetics services. Genet Med. 2012 Sep;14(9):765-76. doi: 10.1038/gim.2012.40. Epub 2012 Apr 12. Review. — View Citation
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. Review. — View Citation
Jarvik GP, Amendola LM, Berg JS, Brothers K, Clayton EW, Chung W, Evans BJ, Evans JP, Fullerton SM, Gallego CJ, Garrison NA, Gray SW, Holm IA, Kullo IJ, Lehmann LS, McCarty C, Prows CA, Rehm HL, Sharp RR, Salama J, Sanderson S, Van Driest SL, Williams MS, Wolf SM, Wolf WA; eMERGE Act-ROR Committee and CERC Committee; CSER Act-ROR Working Group, Burke W. Return of genomic results to research participants: the floor, the ceiling, and the choices in between. Am J Hum Genet. 2014 Jun 5;94(6):818-26. doi: 10.1016/j.ajhg.2014.04.009. Epub 2014 May 8. — View Citation
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. — View Citation
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. — View Citation
Quarrell OW, Rigby AS, Barron L, Crow Y, Dalton A, Dennis N, Fryer AE, Heydon F, Kinning E, Lashwood A, Losekoot M, Margerison L, McDonnell S, Morrison PJ, Norman A, Peterson M, Raymond FL, Simpson S, Thompson E, Warner J. Reduced penetrance alleles for Huntington's disease: a multi-centre direct observational study. J Med Genet. 2007 Mar;44(3):e68. — View Citation
Smith LA, Ullmann JF, Olson HE, Achkar CM, Truglio G, Kelly M, Rosen-Sheidley B, Poduri A. A Model Program for Translational Medicine in Epilepsy Genetics. J Child Neurol. 2017 Mar;32(4):429-436. doi: 10.1177/0883073816685654. Epub 2017 Jan 6. — View Citation
Trondsen MV, Bolle SR, Stensland GØ, Tjora A. Video-confidence: a qualitative exploration of videoconferencing for psychiatric emergencies. BMC Health Serv Res. 2014 Oct 31;14:544. doi: 10.1186/s12913-014-0544-y. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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