Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT03421327
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2018-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic Risk: Whether, When, and How to Tell Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}, {'id': 'D061325', 'term': 'Hereditary Breast and Ovarian Cancer Syndrome'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Qualitative analysis of how parents and children with either Huntington's Disease or hereditary cancer communicate about genetic risk information", 'timeFrame': '1.5 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Huntington Disease', 'Hereditary Breast and Ovarian Cancer', 'Hereditary Cancer', 'Hereditary Non-polyposis Colon Cancer', 'Hereditary Non-Polyposis Colorectal Cancer Syndrome']}, 'referencesModule': {'references': [{'pmid': '28056630', 'type': 'BACKGROUND', '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.'}, {'pmid': '24814192', 'type': 'BACKGROUND', '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.'}, {'pmid': '24919982', 'type': 'BACKGROUND', '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.'}, {'pmid': '15637391', 'type': 'BACKGROUND', 'citation': 'Garber JE, Offit K. Hereditary cancer predisposition syndromes. J Clin Oncol. 2005 Jan 10;23(2):276-92. doi: 10.1200/JCO.2005.10.042.'}, {'pmid': '17361007', 'type': 'BACKGROUND', '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. doi: 10.1136/jmg.2006.045120."}, {'pmid': '9497246', 'type': 'BACKGROUND', '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. doi: 10.1086/301749.'}, {'pmid': '18200514', 'type': 'BACKGROUND', '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.'}, {'pmid': '25133565', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '24746247', 'type': 'BACKGROUND', '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.'}, {'pmid': '21097566', 'type': 'BACKGROUND', '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."}, {'pmid': '22498847', 'type': 'BACKGROUND', '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.'}, {'pmid': '25391849', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25359404', 'type': 'BACKGROUND', 'citation': 'Trondsen MV, Bolle SR, Stensland GO, 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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nFor 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents at-risk for HD, affected by HD, or be the spouse/partner of someone living who at risk for or affected by HD.\n* 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.\n* Children ages 15-17 who are at risk for either HD or hereditary cancer\n\nExclusion Criteria:\n\n* Parents and children who have not yet communicated about genetic risk\n* Children younger than age 15'}, 'identificationModule': {'nctId': 'NCT03421327', 'briefTitle': 'Genetic Risk: Whether, When, and How to Tell Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Genetic Risk: Whether, When, and How to Tell Adolescents', 'orgStudyIdInfo': {'id': 'IRB00121662'}, 'secondaryIdInfos': [{'id': 'R01HG008045', 'link': 'https://reporter.nih.gov/quickSearch/R01HG008045', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Families at-risk for HD', 'description': '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.'}, {'label': 'Families at-risk for hereditary cancer', 'description': '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.'}, {'label': 'Genetic Counselors', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Debra Mathews, PhD, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Berman Institute of Bioeithics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}