Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT02154633
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2014-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lessons Learned From the Family Gene Toolkit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intention for genetic testing', 'timeFrame': '1 month post-intervention', 'description': 'Intention to have genetic testing'}, {'measure': 'Decisional conflict for genetic testing', 'timeFrame': '1 month post-intervention', 'description': 'Difficulty deciding about having genetic testing'}, {'measure': 'Decisional regret', 'timeFrame': '1 month post-intervention', 'description': 'Regret after having genetic testing'}], 'secondaryOutcomes': [{'measure': 'Knowledge of BRCA1/2 genetics', 'timeFrame': '1 month post-intervention', 'description': 'Genetic literacy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Women With BRCA 1 or BRCA 2 Mutation', 'Non-tested Female Family Members']}, 'referencesModule': {'references': [{'pmid': '29653920', 'type': 'RESULT', 'citation': 'Katapodi MC, Jung M, Schafenacker AM, Milliron KJ, Mendelsohn-Victor KE, Merajver SD, Northouse LL. Development of a Web-based Family Intervention for BRCA Carriers and Their Biological Relatives: Acceptability, Feasibility, and Usability Study. JMIR Cancer. 2018 Apr 13;4(1):e7. doi: 10.2196/cancer.9210.'}]}, 'descriptionModule': {'briefSummary': 'Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). However, uptake of genetic testing among at-risk individuals is low, implying that information about the disease and genetic testing is not being communicated effectively among family members. Mutation carriers are distressed about disclosing test results, while their relatives do not understand the implications of a positive test result for their own health. Thus, interventions that support family communication about genetic risk, and address psychological distress of family members could contribute to more effective management of hereditary breast/ovarian cancer.\n\nThe project aims to develop a family communication and decision-support intervention to 1) increase family communication about BRCA1/2 mutations; 2) reduce psychological distress associated with these mutations; and 3) increase informed decision-making regarding uptake of BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk relatives will inform the refinement of the intervention, as well as timing and mode of delivery. Two group, pre-post test study with a new sample of mutation carriers and family members will be used to test the feasibility, acceptability, and effect of the intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for mutation carrier:\n\n1. had genetic testing for BRCA 1 or BRCA 2, and received positive test results;\n2. are older than 18 years;\n3. speak English;\n4. agree to invite in the study one female relative who has ≥10% of carrying a genetic mutation AND did not have genetic testing; and\n5. have access to an Internet enabled computer.\n\nInclusion Criteria for relatives\n\n1. did not have genetic testing for BRCA 1 or BRCA 2;\n2. are older than 18 years;\n3. speak English; and\n4. have access to an Internet enabled computer.\n\nExclusion Criteria:\n\n* Women who have no female relatives\n* Women who are unable to consent\n* Women who do not have access to the Internet or the computer'}, 'identificationModule': {'nctId': 'NCT02154633', 'acronym': 'FGT', 'briefTitle': 'Lessons Learned From the Family Gene Toolkit', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Development of a Family Communication and Decision-support Intervention for Women That Carry a BRCA1 or a BRCA2 Mutation and Their At-Risk Female Family Members', 'orgStudyIdInfo': {'id': 'RWJ68039'}, 'secondaryIdInfos': [{'id': 'Nurse Faculty Scholar 68039', 'type': 'OTHER_GRANT', 'domain': 'Robert Wood Johnson Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family Gene Toolkit', 'description': 'Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes', 'interventionNames': ['Behavioral: Family Gene Toolkit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Family Gene Toolkit', 'description': 'Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes', 'interventionNames': ['Behavioral: Delayed Family Gene Toolkit']}], 'interventions': [{'name': 'Family Gene Toolkit', 'type': 'BEHAVIORAL', 'description': "Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention", 'armGroupLabels': ['Family Gene Toolkit']}, {'name': 'Delayed Family Gene Toolkit', 'type': 'BEHAVIORAL', 'description': "Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention", 'armGroupLabels': ['Delayed Family Gene Toolkit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Maria C Katapodi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adjunct Associate Professor w/ Tenure'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Request for data, explanation of research question, and time frame'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}