Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-01 @ 11:17 PM
Study NCT ID:
NCT07084168
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimedia Aid for Genetic Testing in Gynecologic Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of genetic testing', 'timeFrame': 'Baseline', 'description': 'Proportion of eligible patients undergoing any genetic testing before and after the implementation of educational videos.'}], 'secondaryOutcomes': [{'measure': 'Overall rates of genetic testing', 'timeFrame': 'Baseline', 'description': 'Overall rates of genetic testing before and after the implementation of multimedia videos for patient education.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Baseline', 'description': 'Total scores on patient satisfaction will be measured by a survey. Items are rated by patients on a Likert scale from 1 to 5. Higher scores represent better satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genetic testing', 'video implementation', 'chart review'], 'conditions': ['Ovary Cancer', 'Endometrial Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'Clinical trials at UNC Lineberger'}]}, 'descriptionModule': {'briefSummary': 'This pilot study aims to estimate rates of genetic testing in patients with ovarian and endometrial cancer before and after the implementation of educational videos about genetic testing. Subjects will be asked to view one of three videos relevant to their cancer diagnosis and genetic testing, and have the option to complete a brief satisfaction survey. A chart review to evaluate rates of genetic testing ordered and referrals placed to Genetics before and after the implementation of the videos will be conducted.\n\nUp to 15-20% of ovarian cancer and 3-5% of endometrial cancer is due to inherited genetic mutation. Given this association, the National Comprehensive Cancer Network (NCCN) recommends genetic counseling and testing for all individuals with a diagnosis of ovarian cancer and endometrial cancer. Some challenges to obtaining genetic counseling and testing include missed identification and referral of eligible patients by providers, lack of provider knowledge, and busy clinic visits limiting time for informed consent and maintaining patient autonomy for genetic testing. Although heterogeneous, the literature supports multimedia use in cancer genetics. However, there is a paucity of data in the field of gynecologic oncology for the role of integrating a multimedia approach to genetic counseling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to participate in this study, a subject must meet all of the eligibility criteria outlined below.\n\n* Reviewed informed consent to participate in the study.\n* Subject is willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Diagnosis of ovarian cancer or endometrial cancer\n* Eligible for genetic testing\n* English or Spanish is the primary language\n\nExclusion Criteria:\n\n* Previously completed genetic testing\n* Did not receive initial cancer-directed treatment at study site'}, 'identificationModule': {'nctId': 'NCT07084168', 'briefTitle': 'Multimedia Aid for Genetic Testing in Gynecologic Oncology', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Multimedia Aid for Genetic Testing in Gynecologic Oncology', 'orgStudyIdInfo': {'id': 'LCCC2417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genetic Testing Awarness', 'description': 'Educational videos about genetic testing will be provided for ovarian cancer and endometrial cancer.', 'interventionNames': ['Behavioral: Educational videos', 'Behavioral: Survey']}], 'interventions': [{'name': 'Educational videos', 'type': 'BEHAVIORAL', 'otherNames': ['Genetic testing information'], 'description': 'Educational videos about genetic testing will be provided. Subjects will be asked to view one of three videos (an endometrial cancer/Lynch Syndrome video or a longer or shorter version of an ovarian cancer video) relevant to their cancer diagnosis and genetic testing.', 'armGroupLabels': ['Genetic Testing Awarness']}, {'name': 'Survey', 'type': 'BEHAVIORAL', 'description': 'Subjects will be asked to complete a brief satisfaction survey.', 'armGroupLabels': ['Genetic Testing Awarness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luz Cuaboy', 'role': 'CONTACT', 'email': 'luz_cuaboy@med.unc.edu', 'phone': '919-962-0070'}, {'name': 'Katherine Tucker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univeristy of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Luz Cuaboy', 'role': 'CONTACT', 'email': 'luz_cuaboy@med.unc.edu', 'phone': '919-843-5400'}], 'overallOfficials': [{'name': 'Katherine Tucker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}