Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-05 @ 6:28 PM
Study NCT ID:
NCT06994832
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Visual Arrays to Support Understanding of Genetic Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One-to-one randomization into two parallel groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1045}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk Accuracy', 'timeFrame': 'immediately after the intervention', 'description': 'closest approximation to risk percentage depicted in the visual array'}], 'secondaryOutcomes': [{'measure': 'Risk Perceptions', 'timeFrame': 'baseline', 'description': 'Perceptions of deliberative, affective, and experiential risk using 7-point Likert-type scales'}, {'measure': 'Communication Intent', 'timeFrame': 'immediately after the intervention', 'description': 'Intent to communicate risk to blood relatives using 7-point Likert-type scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lynch syndrome', 'colorectal cancer', 'colon cancer', 'genetic testing'], 'conditions': ['Decision Aid']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand how people understand risk from genetic testing. The investigators want to understand what visual aid best helps people accurately assess risk. The investigators also want to understand how people relate risk to their health. The main questions the study aims to answer are:\n\n1. Which visual aid most accurately show genetic risk?\n2. How do people perceive risk related to genetic test results?\n3. What factors are associated with people discussing their results with family?\n\nParticipants will:\n\n1. receive of of two visual aids showing risk\n2. state their estimation of risk\n3. answer questions about how they feel about risk and sharing information with family', 'detailedDescription': 'This study aims to determine what visual aid helps people most accurately interpret risk from genetic test results. The study also examines how people perceive risk using the Tripartite Risk Model. Last, the study examines factors that are associated with intention to share genetic test results with family members.\n\nParticipants will provide brief sociodemographic information, complete brief health literacy and numeracy assessments, and questions about how they perceive risk. Participants will be informed of a genetic testing scenario and will receive one of two visual aids. After reviewing the visual aid, participants will state the risk shown in the visual aid and will answer questions about their perceived risk and sharing results with family members (blood relatives).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to read and understand English\n* opt-in consent\n\nExclusion Criteria:\n\n* incorrect responses to validation questions'}, 'identificationModule': {'nctId': 'NCT06994832', 'briefTitle': 'Using Visual Arrays to Support Understanding of Genetic Risk', 'nctIdAliases': ['NCT06905990'], 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Examining Genetic Literacy and Numeracy in the General Population', 'orgStudyIdInfo': {'id': '2025P000889'}, 'secondaryIdInfos': [{'id': 'P50HD104224', 'link': 'https://reporter.nih.gov/quickSearch/P50HD104224', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Visual Array', 'description': 'Single, side-by-side visual array', 'interventionNames': ['Behavioral: Visual Array']}, {'type': 'EXPERIMENTAL', 'label': 'Narrative Visual Array', 'description': 'Evolving narrative showing sequential visual arrays', 'interventionNames': ['Behavioral: Narrative Visual Array']}], 'interventions': [{'name': 'Visual Array', 'type': 'BEHAVIORAL', 'description': 'Single side-by-side visual array', 'armGroupLabels': ['Visual Array']}, {'name': 'Narrative Visual Array', 'type': 'BEHAVIORAL', 'description': 'Evolving narrative with sequential visual arrays', 'armGroupLabels': ['Narrative Visual Array']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston College', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Andrew A Dwyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston College'}]}, 'ipdSharingStatementModule': {'url': 'https://dataverse.harvard.edu/', 'timeFrame': 'Start date: within one month of the publication of study results. End date: one year after posting.', 'ipdSharing': 'YES', 'description': 'Anonymized data will be shared via the HarvardDataverse platform.', 'accessCriteria': 'HarvardDataverse platform'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stephanie B. Seminara, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Boston College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine', 'investigatorFullName': 'Stephanie B. Seminara, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}