Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-20 @ 9:38 PM
Study NCT ID:
NCT06671704
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GC-PRO Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Stepped wedge randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 994}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectiveness of a genetic counseling skills training intervention', 'timeFrame': '1 month', 'description': 'The exact measure of effectiveness has been omitted to ensure no bias is created and that research integrity is preserved'}], 'secondaryOutcomes': [{'measure': 'patient perception of overall GC quality', 'timeFrame': '1 month', 'description': 'Overall perception of quality of the genetic counseling session'}, {'measure': 'patient-centered communication', 'timeFrame': '1 month', 'description': "An assessment of the patient's experience with their healthcare provider"}, {'measure': 'patient empowerment', 'timeFrame': '1 month', 'description': 'A process through which patients gain control over decisions and actions affecting their health'}, {'measure': 'patient activation', 'timeFrame': '1 month', 'description': "A patient's ability to manage their own health and take an active role in their care"}, {'measure': 'patient information needs met / information overload', 'timeFrame': '1 month', 'description': 'Assessment of how much information the patient desired and was provided'}, {'measure': "patients' perceived trust in GC", 'timeFrame': '1 month', 'description': "Measure of patients' trust in their provider"}, {'measure': 'working alliance', 'timeFrame': '1 month', 'description': 'Relationship between patient and provider'}, {'measure': 'GC verbal dominance', 'timeFrame': '1 month', 'description': 'Measurement of the amount of time the patient, genetic counselor, and other individuals spend talking in the session'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genetic counseling', 'cancer', 'heart disease', 'reproductive', 'prenatal', 'genetic'], 'conditions': ['Cancer', 'Cardiovascular Diseases', 'Prenatal Condition', 'Reproductive Condition', 'Genetic Condition']}, 'descriptionModule': {'briefSummary': 'The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* individual OR their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site\n* understand and be able to provide information for study forms and surveys in English.\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.'}, 'identificationModule': {'nctId': 'NCT06671704', 'briefTitle': 'GC-PRO Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'GC-PRO Intervention', 'orgStudyIdInfo': {'id': 'CBS-2024-33212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cluster 1', 'description': 'Patients recruited and randomized to transfer from standard of care to genetic counselling in months 4-15', 'interventionNames': ['Other: Genetic counseling months 4-15']}, {'type': 'EXPERIMENTAL', 'label': 'Cluster 2', 'description': 'Patients recruited and randomized to transfer from standard of care to genetic counselling in months 6-15', 'interventionNames': ['Other: Genetic counseling months 6-15']}, {'type': 'EXPERIMENTAL', 'label': 'Cluster 3', 'description': 'Patients recruited and randomized to transfer from standard of care to genetic counselling in months 8-15', 'interventionNames': ['Other: Genetic counseling months 8-15']}, {'type': 'EXPERIMENTAL', 'label': 'Cluster 4', 'description': 'Patients recruited and randomized to transfer from standard of care to genetic counselling in months 10-15', 'interventionNames': ['Other: Genetic counseling at months 10-15']}, {'type': 'EXPERIMENTAL', 'label': 'Cluster 5', 'description': 'Patients recruited and randomized to transfer from standard of care to genetic counselling in months 12-15', 'interventionNames': ['Other: Genetic counseling at months 12-15']}, {'type': 'EXPERIMENTAL', 'label': 'Cluster 6', 'description': 'Patients recruited and randomized to transfer from standard of care to genetic counselling in months 14-15', 'interventionNames': ['Other: Genetic counseling at months 14-15']}], 'interventions': [{'name': 'Genetic counseling months 4-15', 'type': 'OTHER', 'description': 'all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 4 to month 15.', 'armGroupLabels': ['Cluster 1']}, {'name': 'Genetic counseling months 6-15', 'type': 'OTHER', 'description': 'all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 6 to month 15.', 'armGroupLabels': ['Cluster 2']}, {'name': 'Genetic counseling months 8-15', 'type': 'OTHER', 'description': 'all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 8 to month 15.', 'armGroupLabels': ['Cluster 3']}, {'name': 'Genetic counseling at months 10-15', 'type': 'OTHER', 'description': 'all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 10 to month 15.', 'armGroupLabels': ['Cluster 4']}, {'name': 'Genetic counseling at months 12-15', 'type': 'OTHER', 'description': 'all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 12 to month 15.', 'armGroupLabels': ['Cluster 5']}, {'name': 'Genetic counseling at months 14-15', 'type': 'OTHER', 'description': 'all genetic counselors within the same specialty at the same site will cross over from standard of care to the intervention training starting at month 14 to month 15.', 'armGroupLabels': ['Cluster 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elena Fischer', 'role': 'CONTACT', 'email': 'fishe912@umn.ed', 'phone': '612-626-6743'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Elena Fisher', 'role': 'CONTACT', 'email': 'fishe912@umn.edu', 'phone': '612-626-6743'}], 'overallOfficials': [{'name': 'Heather Zierhut', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of South Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}