Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-31 @ 12:40 AM
Study NCT ID:
NCT05073432
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of a Personalized Discussion Prioritization Tool for Older Adults Considering Adjuvant Chemotherapy for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'allison_magnuson@urmc.rochester.edu', 'phone': '585-602-5085', 'title': 'Dr. Allison Magnuson', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'Electronic completion of Geriatric Assessment and Conjoint Analysis with result output.\n\nExperimental: Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Functional Assessment of the Discussion Prioritization Tool (DPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Electronic completion of Geriatric Assessment and Conjoint Analysis with result output.\n\nExperimental: Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'spread': '26.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Months', 'description': 'System Usability Scale (SUS) (score on a 10-item scale, with a total score ranging from 0-100; a higher score corresponds to greater usability). We will deem the tool usable if our mean SUS score among the 10 patients enrolled is \\>68.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'Electronic completion of Geriatric Assessment and Conjoint Analysis with result output.\n\nExperimental: Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'Electronic completion of Geriatric Assessment and Conjoint Analysis with result output.\n\nExperimental: Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-11', 'size': 804364, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-06T09:31', 'hasProtocol': True}, {'date': '2021-11-29', 'size': 389936, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-12T10:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2021-09-28', 'resultsFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-09', 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Assessment of the Discussion Prioritization Tool (DPT)', 'timeFrame': '2 Months', 'description': 'System Usability Scale (SUS) (score on a 10-item scale, with a total score ranging from 0-100; a higher score corresponds to greater usability). We will deem the tool usable if our mean SUS score among the 10 patients enrolled is \\>68.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Discussion Prioritization Tool (DPT)'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators have developed a Discussion Prioritization Tool (DPT) for older adults consider adjuvant chemotherapy that utilizes Conjoint Analysis (CA) methodology and the objective of the current study is to assess usability of this DPT in the target population, older adults with breast cancer and to adapt the tool to optimize usability for the target population.', 'detailedDescription': "Given the complexity of adjuvant chemotherapy decision making for older adults with breast cancer, enhancing support and promoting treatment discussions in the context of patient's goals and preferences is an important need. With this need in mind, the investigators have completed interviews with patients with cancer patients who are considering adjuvant therapy. As a result of these interviews, the investigators have developed a common list of attributes (variables found to be important in decision making) that were used to create the Discussion Prioritization Tool (DPT) using Conjoint Analysis (CA) methodology. CA which is a method that can assess the relative importance that patients place on different aspects of care by asking patients to make a series of trade-offs between competing options. The purpose of this study is to assess the usability of a Discussion Prioritization Tool, administered through a tablet, laptop, or computer, for its ability to aid in treatment decision-making. The investigators would like to gather feedback from individuals to improve and adapt the communication tool."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥65\n* Diagnosis of stage I-III BC\n* Being considered for adjuvant chemotherapy\n* Able to speak and read English\n* Able to participate in study procedures.\n\nExclusion Criteria:\n\n* Lacking medical decision-making capacity as determined by their oncologist\n* Evidence of metastatic disease'}, 'identificationModule': {'nctId': 'NCT05073432', 'briefTitle': 'Development of a Personalized Discussion Prioritization Tool for Older Adults Considering Adjuvant Chemotherapy for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Study in Development of a Personalized Discussion Prioritization Tool for Older Adults Considering Adjuvant Chemotherapy for Breast Cancer', 'orgStudyIdInfo': {'id': 'UCCS20110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Electronic completion of Geriatric Assessment and Conjoint Analysis with result output.', 'interventionNames': ['Other: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': 'Usability of the Discussion Prioritization Tool (DPT) by completing Geriatric Assessment and Conjoint Analysis', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Allison Magnuson, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ. of Rochester Wilmot Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)', 'investigatorFullName': 'Allison Magnuson', 'investigatorAffiliation': 'University of Rochester'}}}}