Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT03885908
Status:
TERMINATED
Last Update Posted:
2024-03-25
First Post:
2019-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shahroka@mskcc.org', 'phone': '646-888-3651', 'title': 'Dr. Armin Shahrokni, MD, MPH', 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'In-person Geriatric Co-management Group', 'description': '"In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Automated Geriatric Co-management Program Group', 'description': 'automated geriatric co-management: Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Automated Geriatric Co-management Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In-person Geriatric Co-management Group', 'description': '"In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.'}, {'id': 'OG001', 'title': 'Automated Geriatric Co-management Program Group', 'description': 'automated geriatric co-management: Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.'}], 'timeFrame': '2 years', 'description': 'percentage of recommendations that were followed by the surgery team', 'reportingStatus': 'POSTED', 'populationDescription': 'N/A data were not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'In-person Geriatric Co-management Group', 'description': '"In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.'}, {'id': 'FG001', 'title': 'Automated Geriatric Co-management Program Group', 'description': 'automated geriatric co-management: Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Patient deemed to be ineligible due to language preference', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient became ineligible becasue she underwent neoaedjuvant chemotherapy before surgery.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient did not undergo surgery within 2 months of consent.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient unable to complete appointment - withdrawn from study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'In-person Geriatric Co-management Group', 'description': '"In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.'}, {'id': 'BG001', 'title': 'Automated Geriatric Co-management Program Group', 'description': 'automated geriatric co-management: Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '88'}, {'value': '76', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '80'}, {'value': '76', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-10', 'size': 1120737, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-21T15:24', 'hasProtocol': True}, {'date': '2020-12-10', 'size': 492311, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-23T08:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The proposed study is a randomized controlled trial study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2019-03-20', 'resultsFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-22', 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Automated Geriatric Co-management Program', 'timeFrame': '2 years', 'description': 'percentage of recommendations that were followed by the surgery team'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Automated Geriatric Co-Management Program', 'Perioperative Care', 'Solid mass', 'Nodule', '19-066'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if it is possible to use the automated geriatric co-management program to manage the participants care before, during and after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solid mass or nodule suspicious for cancer\n* Aged 65 or older\n* Being considered for surgical resection of the solid mass or nodule, with anticipated hospital length of stay of at least two days,\n* Completed the eRFA per routine care\n\nExclusion Criteria:\n\n* Unable to read or comprehend English\n* Not having a completed electronic Rapid Fitness Assessment within 2 months of surgery\\*\\*Note) To avoid excluding patients based this item, patients have to complete another eRFA within two months of surgery.\n* Being discharged in one day or earlier from the hospital.'}, 'identificationModule': {'nctId': 'NCT03885908', 'briefTitle': 'Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Feasibility and Effectiveness of Automated Geriatric Co-Management Program on Improving the Perioperative Care of Older Patients With Solid Mass or Nodule Suspicious for Cancer', 'orgStudyIdInfo': {'id': '19-066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'In-person geriatric co-management group', 'description': '"In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.', 'interventionNames': ['Other: in-person geriatric co-management']}, {'type': 'EXPERIMENTAL', 'label': 'Automated geriatric co-management program group', 'interventionNames': ['Other: automated geriatric co-management']}], 'interventions': [{'name': 'in-person geriatric co-management', 'type': 'OTHER', 'description': 'The geriatrics service sees these patients for at least 2 postoperative days, if deemed clinically necessary by the geriatrician. During the inpatient hospital course, the geriatrics service will ensure the execution of preoperative recommendations and will discuss with the surgical team, who will act as a primary team, any additional recommendation in order to improve postoperative care. "In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.', 'armGroupLabels': ['In-person geriatric co-management group']}, {'name': 'automated geriatric co-management', 'type': 'OTHER', 'description': 'Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.', 'armGroupLabels': ['Automated geriatric co-management program group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Armin Shahrokni, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}