Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05470920
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2022-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic Testing Decision Aid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average change in knowledge survey score', 'timeFrame': 'baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks', 'description': 'Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.'}, {'measure': 'Decisional Conflict Scores', 'timeFrame': '1 week after genetics session', 'description': "The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict."}, {'measure': 'Shared Decision Making Process Scores', 'timeFrame': '1 week after genetics session', 'description': 'The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.'}], 'secondaryOutcomes': [{'measure': 'Average time between genetic testing recommendation and sample collection', 'timeFrame': 'Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months', 'description': 'Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.'}, {'measure': 'Average Duration of Decision Making Process', 'timeFrame': 'Approximately 30 minutes - 1 hour', 'description': 'Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.'}, {'measure': 'Ratio of the number of participants who chose each of the three panels offered', 'timeFrame': 'At the conclusion of genetics session (day 1)', 'description': 'Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.'}, {'measure': 'Percentage of participants choosing genetic testing', 'timeFrame': 'At the conclusion of genetics session (day 1)', 'description': 'Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreas adenocarcinoma.', 'epithelial ovarian carcinoma', 'decision aid', 'inherited cancer syndrome', 'genetic testing'], 'conditions': ['Epithelial Ovarian Carcinoma', 'Pancreas Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer', 'detailedDescription': 'The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include:\n\n* Knowledge Survey\n* Shared Decision Making Process Survey\n* Decisional Conflict Scale\n\nThe research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study.\n\nThe National Cancer Institute (NCI) is supporting this research study by providing funding for the research'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Being seen in clinic at Massachusetts General Hospital or Boston Medical Center\n* Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.\n\nExclusion Criteria :\n\n* Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study\n* Previous germline genetic testing\n* History of hereditary pancreatitis\n* Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults'}, 'identificationModule': {'nctId': 'NCT05470920', 'briefTitle': 'Genetic Testing Decision Aid', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes', 'orgStudyIdInfo': {'id': '22-155'}, 'secondaryIdInfos': [{'id': 'U01CA243695', 'link': 'https://reporter.nih.gov/quickSearch/U01CA243695', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic decision aid arm', 'description': 'Receive decision aid followed by an appointment with their oncologist.', 'interventionNames': ['Behavioral: Electronic Decision Aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Genetic counselor Arm', 'description': 'Receive pretest counseling with a genetic counselor.', 'interventionNames': ['Behavioral: Pre-Test Genetic Counseling']}], 'interventions': [{'name': 'Electronic Decision Aid', 'type': 'BEHAVIORAL', 'description': 'Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires', 'armGroupLabels': ['Electronic decision aid arm']}, {'name': 'Pre-Test Genetic Counseling', 'type': 'BEHAVIORAL', 'description': 'Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires', 'armGroupLabels': ['Genetic counselor Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel C. Chung, MD', 'role': 'CONTACT', 'email': 'Chung.daniel@mgh.harvard.edu', 'phone': '(617) 726-8687'}, {'name': 'Daniel C. Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01923', 'city': 'Danvers', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Bouberhan, MD', 'role': 'CONTACT', 'email': 'SBOUBERHAN@MGH.HARVARD.EDU'}, {'name': 'Sara Bouberhan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mass General at North Shore Cancer Center', 'geoPoint': {'lat': 42.57509, 'lon': -70.93005}}], 'centralContacts': [{'name': 'Daniel C. Chung, MD', 'role': 'CONTACT', 'email': 'Chung.daniel@mgh.harvard.edu', 'phone': '(617) 726-8687'}, {'name': 'Danielle A Lynch, BS', 'role': 'CONTACT', 'email': 'dlynch22@mgh.harvard.edu', 'phone': '(617) 726-1355'}], 'overallOfficials': [{'name': 'Daniel C. Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Partners Innovations team at http://www.partners.org/innovation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniel C Chung', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}