Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT04704193
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chung.daniel@mgh.harvard.edu', 'phone': '617-726-8687', 'title': 'Daniel Chung, MD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Electronic Decision Aid', 'description': 'Participants in this arm will complete an electronic decision aid for genetic testing.\n\nSurvey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant Satisfaction With How Educational Information is Presented in the Decision Aid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Decision Aid', 'description': 'Participants in this arm will complete an electronic decision aid for genetic testing.\n\nSurvey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.'}], 'classes': [{'title': 'Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Rating: Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Rating: Fair', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Rating: Good', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Rating: Excellent', 'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Genetic test results may help guide my treatment options', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Rating: Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Rating: Fair', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Rating: Good', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Rating: Excellent', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Genetic test results may help me understand the future risks of other cancers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Rating: Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Rating: Fair', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Rating: Good', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Rating: Excellent', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Genetic test results may increase stress to me and my family members', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Rating: Poor', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Rating: Fair', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Rating: Good', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Rating: Excellent', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'There are 3 gene panel options that include either a small, medium, or large number of genes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Rating: Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Rating: Fair', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Rating: Good', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Rating: Excellent', 'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Gene test results may come back as positive, negative, or uncertain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Rating: Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Rating: Fair', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Rating: Good', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Rating: Excellent', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'count with proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.955', 'ciLowerLimit': '.888', 'ciUpperLimit': '.987', 'groupDescription': 'Descriptive statistics only/proportion reported good or excellent\n\nQ1a. Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This arm includes descriptive statistics only.'}, {'groupIds': ['OG000'], 'paramType': 'count with proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.931', 'ciLowerLimit': '.856', 'ciUpperLimit': '.974', 'groupDescription': 'Descriptive statistics only/proportion reported good or excellent\n\nQ1b. Genetic test results may help guide my treatment options', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This arm includes descriptive statistics only.'}, {'groupIds': ['OG000'], 'paramType': 'count with proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.943', 'ciLowerLimit': '.872', 'ciUpperLimit': '.981', 'groupDescription': 'Descriptive statistics only/proportion reported good or excellent\n\nQ1c. Genetic test results may help me understand the future risks of other cancers', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This arm includes descriptive statistics only.'}, {'groupIds': ['OG000'], 'paramType': 'count with proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.851', 'ciLowerLimit': '.758', 'ciUpperLimit': '.918', 'groupDescription': 'Descriptive statistics only/proportion reported good or excellent\n\nQ1d. Genetic test results may increase stress to me and my family members', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This arm includes descriptive statistics only.'}, {'groupIds': ['OG000'], 'paramType': 'count with proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.931', 'ciLowerLimit': '.856', 'ciUpperLimit': '.974', 'groupDescription': 'Descriptive statistics only/proportion reported good or excellent\n\nQ1e. There are 3 gene panel options that include either a small, medium, or large number of genes', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This arm includes descriptive statistics only.'}, {'groupIds': ['OG000'], 'paramType': 'count with proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.919', 'ciLowerLimit': '.839', 'ciUpperLimit': '.967', 'groupDescription': 'Descriptive statistics only/proportion reported good or excellent\n\nQ1f. Gene test results may come back as positive, negative or uncertain', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This arm includes descriptive statistics only.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.', 'description': 'Measured with 6 items on a questionnaire that asks participants to rate the way certain information is presented on the decision aid. Each item is rated on a scale of 1 to 4, with 1 being poor and 4 being excellent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 88 participants agreed to complete this survey. For questions 1b, 1d, and 1e there are only 87 complete answer choices. For question 1f, there are only 86 complete answer choices.'}, {'type': 'SECONDARY', 'title': 'Total Time Spent on Decision Aid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Decision Aid', 'description': 'Participants in this arm will complete an electronic decision aid for genetic testing.\n\nSurvey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean', 'ciNumSides': 'TWO_SIDED', 'paramValue': '13.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.6', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Summary statistics only'}], 'paramType': 'MEAN', 'timeFrame': 'From the start of the decision aid to the completion of the decision aid', 'description': 'The total amount of minutes spent on the decision aid', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 85 participants who completed the Electronic Decision Aid tool.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electronic Decision Aid', 'description': 'Participants in this arm will complete an electronic decision aid for genetic testing.\n\nSurvey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Electronic Decision Aid', 'description': 'Participants in this arm will complete an electronic decision aid for genetic testing.\n\nSurvey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.75', 'spread': '12.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Of the 93 participants, only 92 participants completed the study. Only the information from the 92 participants is included in the baseline characteristics analysis because one participant withdrew from the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-03', 'size': 123090, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-20T15:11', 'hasProtocol': True}, {'date': '2024-07-18', 'size': 103072, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-18T13:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2021-01-07', 'resultsFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-18', 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Satisfaction With How Educational Information is Presented in the Decision Aid', 'timeFrame': 'This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.', 'description': 'Measured with 6 items on a questionnaire that asks participants to rate the way certain information is presented on the decision aid. Each item is rated on a scale of 1 to 4, with 1 being poor and 4 being excellent.'}], 'secondaryOutcomes': [{'measure': 'Total Time Spent on Decision Aid', 'timeFrame': 'From the start of the decision aid to the completion of the decision aid', 'description': 'The total amount of minutes spent on the decision aid'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decision Aid'], 'conditions': ['Genetic Testing']}, 'descriptionModule': {'briefSummary': "An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years of age or older)\n* Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma\n\nExclusion Criteria:\n\n* Children (\\<18 years of age)\n* Unable to complete surveys\n* Previous germline genetic testing'}, 'identificationModule': {'nctId': 'NCT04704193', 'briefTitle': 'Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes', 'orgStudyIdInfo': {'id': '2020P003422'}, 'secondaryIdInfos': [{'id': 'U01CA243695-01', 'link': 'https://reporter.nih.gov/quickSearch/U01CA243695-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic Decision Aid', 'description': 'Participants in this arm will complete an electronic decision aid for genetic testing.', 'interventionNames': ['Other: Survey of Decision Aid']}], 'interventions': [{'name': 'Survey of Decision Aid', 'type': 'OTHER', 'description': 'The decision aid will be evaluated by a survey administered to those who have used the tool.', 'armGroupLabels': ['Electronic Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Daniel C Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Medical Center', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Daniel C Chung, MD; Director, High-Risk GI Cancer Clinic', 'investigatorFullName': 'Daniel C Chung', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}