Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04789018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology, ENGAGEMENT Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Likert scaled perceived usefulness scores of the virtual genetics board', 'timeFrame': 'After virtual genetics board', 'description': 'Perceived usefulness will be judged against a benchmark mean score of 5/7.'}], 'secondaryOutcomes': [{'measure': 'Means or changes in means of Likert scaled acceptability/feasibility', 'timeFrame': 'Before and after virtual genetics board', 'description': 'Will be summarized by means, standard deviations, and 95% confidence intervals.'}, {'measure': 'Perceived ease of use', 'timeFrame': 'After virtual genetics board', 'description': 'Will be summarized by means, standard deviations, and 95% confidence intervals.'}, {'measure': 'Self-efficacy for recommendations', 'timeFrame': 'Before and after virtual genetics board', 'description': 'Will be summarized by means, standard deviations, and 95% confidence intervals.'}, {'measure': 'Change in mean scores on 17 genetics knowledge test questions', 'timeFrame': 'Baseline up to post-virtual genetics board', 'description': 'Will be summarized by means, standard deviations, and 95% confidence intervals.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study assesses perceived usefulness of a web-based virtual prostate cancer genetics board for providers across academic, community, and veteran affairs settings to discuss prostate cancer genetics cases, precision treatment, and screening recommendation. Information gained from interviews and surveys of participants taking part in the virtual genetics board may lend insights into perceived usefulness, perceived ease of use, acceptability, self-efficacy, genetics knowledge, and barriers/facilitators to implementation to refine the process.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess perceived usefulness of a virtual genetics board.\n\nSECONDARY OBJECTIVE:\n\nI. To assess acceptability/feasibility, perceived ease of use, self-efficacy for recommendations, genetics knowledge.\n\nOUTLINE:\n\nParticipants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board. After virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge. Participants may also complete a semi-structured interview after virtual genetics board.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-genetic providers who perform prostate cancer (PCA) genetic testing for men in their practices (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:\n\n* Healthcare providers (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers) who evaluate, manage, or treat men with prostate cancer or screen men for prostate cancer.\n* Providers who perform prostate cancer genetic testing for men (genetic counselors or healthcare providers)\n* Scientists and researchers\n* Advocacy or patient stakeholder organization members\n\nExclusion Criteria:\n\n• Non-medical providers'}, 'identificationModule': {'nctId': 'NCT04789018', 'briefTitle': 'Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology, ENGAGEMENT Study', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology ENGAGEMENT Study (Virtual Genetics Board)', 'orgStudyIdInfo': {'id': '20F.936'}, 'secondaryIdInfos': [{'id': 'JT 16041', 'type': 'OTHER', 'domain': 'JeffTrial Number'}, {'id': '080-27000-X17501', 'type': 'OTHER_GRANT', 'domain': 'DOD'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (survey, virtual genetic board, interview)', 'description': 'Participants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board. After virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge. Participants may also complete a semi-structured interview after virtual genetics board.', 'interventionNames': ['Other: Educational Intervention', 'Other: Survey Administration', 'Other: Interview']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational'], 'description': 'Attend virtual genetics board', 'armGroupLabels': ['Observational (survey, virtual genetic board, interview)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete survey', 'armGroupLabels': ['Observational (survey, virtual genetic board, interview)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Complete interview', 'armGroupLabels': ['Observational (survey, virtual genetic board, interview)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Amy Leader, DrPH, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}