Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-04-11 @ 1:20 AM
Study NCT ID:
NCT00530751
Status:
WITHDRAWN
Last Update Posted:
2015-10-02
First Post:
2007-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Views on Sharing Family Medical History in Healthy Women Undergoing Mammograms or Breast Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI left', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2007-09-13', 'studyFirstSubmitQcDate': '2007-09-13', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participants' perspectives and concerns regarding online genetic risk assessment or research"}, {'measure': 'Identification of directions for future research into the ethics of online genetic risk assessment or research'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/show/NCT00530751?term=NCT00530751&rank=1', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about the concerns that individuals may have about providing family medical history online for genetic risk assessment or research may help doctors plan future research.\n\nPURPOSE: This clinical trial is studying views on sharing family medical history in healthy women undergoing mammograms or breast evaluation.', 'detailedDescription': "OBJECTIVES:\n\n* To gain an initial understanding of the ethical, family, and related concerns that individuals may have when offered the option of providing family medical history online for genetic risk assessment or research.\n* To identify specific directions for future research into the ethics of online genetic risk assessment.\n\nOUTLINE: Participants undergo a 45-60 minute interview to assess their attitudes and concerns about providing family medical history online for genetic risk assessment or research. Participants' feelings about whether or not to use an online genetic assessment tool (i.e., Genetic Risk Easy Assessment Tool \\[GREAT\\]) are explored. The GREAT allows for the electronic creation, analysis, and dissemination of family histories of individuals who may be at risk for various types of cancer. Key factors influencing a participant's use of the tool, including concerns about confidentiality, privacy, informed consent, access to risk information, and security of online family history databases, are explored. Ethical issues regarding communication and agreement among family members on disclosing family medical history are also discussed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care center', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Healthy women undergoing mammograms or being evaluated for a breast concern at the University Hospitals Breast Center\n\nPATIENT CHARACTERISTICS:\n\n* Able to speak English\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00530751', 'briefTitle': 'Views on Sharing Family Medical History in Healthy Women Undergoing Mammograms or Breast Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Patient Perspectives on Sharing Family Medical Histories', 'orgStudyIdInfo': {'id': 'CASE1Z07'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE1Z07', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'CASE-1Z07-CC220'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'counseling intervention', 'type': 'OTHER', 'description': "Participants undergo a 45-60 minute interview to assess their attitudes and concerns about providing family medical history online for genetic risk assessment or research. Participants' feelings about whether or not to use an online genetic assessment tool (i.e., Genetic Risk Easy Assessment Tool \\[GREAT\\]) are explored."}]}, 'contactsLocationsModule': {'locations': [{'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Cancer Center at Mercy Medical Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44024', 'city': 'Chardonr', 'state': 'Ohio', 'country': 'United States', 'facility': 'Geauga Regional Hospital'}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lake/University Ireland Cancer Center', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Southwest General Health Center', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '44122', 'city': 'Orange Villager', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS Chagrin Highlands Medical Center'}, {'zip': '44121', 'city': 'South Euclid', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Suburban Health Center', 'geoPoint': {'lat': 41.52311, 'lon': -81.51846}}, {'zip': '44145', 'city': 'Westlaker', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS Westlake Medical Center'}], 'overallOfficials': [{'name': 'Christian Simon, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Christian Simon', 'oldOrganization': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}}}}