Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-04 @ 12:08 PM
Study NCT ID:
NCT06166758
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2023-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study: Educational Genetic Test Video
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the value of presenting patients an educational video regarding the benefits risks, and limitations of genetic testing for hereditary cancer risk.', 'timeFrame': 'Day 1', 'description': 'Determine proof-of concept by the results of a patient survey to assess the effect that the video has on decisional conflict. The survey administered post intervention uses a modified decisional conflict scale in a pre then post format. This is a 5 point Likert scale where 1 equals no, 2= probably no, 3= unsure, 4= probably yes, and 5=yes. This format asks participants to imagine their thoughts on the subject before having watched the video, then to clarify their thoughts on the same subjects now that they have watched the video.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetic testing education'], 'conditions': ['Prostate Cancer', 'Education']}, 'descriptionModule': {'briefSummary': "Assess whether introducing an educational video regarding the benefits, risks, and limitations of genetic testing affects prostate cancer patients' decisional conflict regarding receiving germline genetic testing."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate cancer patients who have been prescribed germline genetic testing by their provider\n* Understand written and spoken English\n* Have not received germline genetic testing for hereditary cancer risk in the past\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant individuals\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT06166758', 'briefTitle': 'Feasibility Study: Educational Genetic Test Video', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Pilot Feasibility Study: Educational Genetic Test Video', 'orgStudyIdInfo': {'id': 'MCC-23-20539'}, 'secondaryIdInfos': [{'id': 'HM20028425', 'type': 'OTHER', 'domain': 'Virginia Commonwealth University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Video', 'description': 'Educational video about germline genetic testing, which is 7 minutes long', 'interventionNames': ['Behavioral: Educational Video']}], 'interventions': [{'name': 'Educational Video', 'type': 'BEHAVIORAL', 'description': 'Educational video regarding the benefits, risks, and limitations of genetic testing for hereditary cancer risk.', 'armGroupLabels': ['Educational Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Elizabeth Monast', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}