Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-04-15 @ 5:04 AM
Study NCT ID:
NCT02133703
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2014-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'C562840', 'term': 'Breast Cancer, Familial'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2014-04-09', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge', 'timeFrame': '1-month post randomization', 'description': 'Knowledge of risk management options.'}, {'measure': 'Decision Conflict', 'timeFrame': '1-month post-randomization', 'description': 'Decisional Conflict Scale'}, {'measure': 'Decision Satisfaction', 'timeFrame': '12-months post-randomization', 'description': 'Satisfaction with Decision Scale'}, {'measure': 'Psychological Distress', 'timeFrame': '1-month post randomization'}, {'measure': 'Health Related Quality of Life', 'timeFrame': '12-months post randomization', 'description': 'SF-12'}, {'measure': 'Utilization of breast and ovarian cancer risk management options', 'timeFrame': '12-months post-randomization', 'description': 'We will assess uptake of the following risk management strategies:\n\n1. Risk reducing surgery (mastectomy and oophorectomy)\n2. Chemoprevention\n3. Breast and ovarian cancer screening'}], 'secondaryOutcomes': [{'measure': 'Knowledge', 'timeFrame': '3-months post randomization', 'description': 'Knowledge of risk management options'}, {'measure': 'Psychological Distress', 'timeFrame': '3-months post-randomization'}, {'measure': 'Decisional Conflict', 'timeFrame': '3-months post-randomization', 'description': 'Decisional Conflict Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Genetic counseling', 'genetic testing', 'BRCA1', 'BRCA2', 'Hereditary breast cancer', 'Hereditary ovarian cancer'], 'conditions': ['Breast Cancer', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergo BRCA1/2 genetic counseling and testing at one of four study sites\n* Receive positive or uninformative test results\n* English speaking\n\nExclusion Criteria:\n\n* Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment\n* Previous bilateral mastectomy'}, 'identificationModule': {'nctId': 'NCT02133703', 'briefTitle': 'Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Decision Making Interventions for Women Receiving Uninformative BRCA1/2 Test Results or Positive BRCA1/2 Test Results', 'orgStudyIdInfo': {'id': '2010-611'}, 'secondaryIdInfos': [{'id': 'R01CA135179-01', 'link': 'https://reporter.nih.gov/quickSearch/R01CA135179-01', 'type': 'NIH'}, {'id': 'R01HG005055', 'link': 'https://reporter.nih.gov/quickSearch/R01HG005055', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mutation Carrier: Enhanced Internet DA', 'description': 'BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool.', 'interventionNames': ['Behavioral: Enhanced Internet DA']}, {'type': 'EXPERIMENTAL', 'label': 'Mutation Carrier: Internet DA', 'description': 'BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool.', 'interventionNames': ['Behavioral: Internet DA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mutation Carrier: Enhanced Print DA', 'description': 'BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool.', 'interventionNames': ['Behavioral: Enhanced Print DA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mutation Carrier: Print DA', 'description': 'BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool.', 'interventionNames': ['Behavioral: Print DA']}, {'type': 'EXPERIMENTAL', 'label': 'Inconclusive Results: DA', 'description': 'Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making', 'interventionNames': ['Behavioral: Inconclusive Results DA']}, {'type': 'NO_INTERVENTION', 'label': 'Inconclusive Results: Usual care', 'description': 'Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention'}], 'interventions': [{'name': 'Enhanced Internet DA', 'type': 'BEHAVIORAL', 'description': 'BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.', 'armGroupLabels': ['Mutation Carrier: Enhanced Internet DA']}, {'name': 'Internet DA', 'type': 'BEHAVIORAL', 'description': 'BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.', 'armGroupLabels': ['Mutation Carrier: Internet DA']}, {'name': 'Enhanced Print DA', 'type': 'BEHAVIORAL', 'description': 'BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.', 'armGroupLabels': ['Mutation Carrier: Enhanced Print DA']}, {'name': 'Print DA', 'type': 'BEHAVIORAL', 'description': 'BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.', 'armGroupLabels': ['Mutation Carrier: Print DA']}, {'name': 'Inconclusive Results DA', 'type': 'BEHAVIORAL', 'description': 'Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.', 'armGroupLabels': ['Inconclusive Results: DA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center/Lombardi Comprehensive Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Marc D Schwartz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}