Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-25 @ 7:12 PM
Study NCT ID:
NCT04824859
Status:
TERMINATED
Last Update Posted:
2025-09-26
First Post:
2021-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Geriatric Assessment Electronic Platform for Older Patients With Cancer (eGAP - Electronic Geriatric Assessment Platform)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Electronic geriatric assessment platform to collect data (e.g., functional status, comorbidity, psychological health) that may better reflect health status of older adults with cancer'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Technology issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2021-03-27', 'studyFirstSubmitQcDate': '2021-03-27', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Retention Rate', 'timeFrame': '1 week', 'description': 'Percentage of patients completing the assessments that are assigned to them on eGAP'}], 'secondaryOutcomes': [{'measure': 'Recruitment rates', 'timeFrame': '1 week', 'description': 'Percentage of patients who are approached and agree to enroll'}, {'measure': 'Self-Report Completion Time', 'timeFrame': '1 week', 'description': 'Time spent on completing the self-reported assessments on the eGAP'}, {'measure': 'System Usability Scale', 'timeFrame': '1 week', 'description': 'For patients, caregivers, and oncology providers: score on 10-item scale, ranging 0-100; higher score corresponds to greater usability'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supportive Care', 'Cancer', 'mHealth', 'Geriatric'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP in 50 older patients with cancer, their caregivers, and their oncology team. Using an iterative process, we will refine the eGAP based on input from stakeholders.', 'detailedDescription': 'A geriatric assessment is a multidisciplinary diagnostic process that can detect medical, psychosocial and functional problems not identified by routine evaluation. This can subsequently guide management of the identified problems. However, the time and resources required to incorporate a geriatric assessment into clinic visits remain the primary barriers for implementation. There is a need to increase the adoption of the geriatric assessment among general oncologists and to address the associated resource limitations. Our long-term goal is to utilize an electronic platform to facilitate completion of the geriatric assessment. This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP) in 50 older patients with cancer, their caregivers, and oncology providers. Using an iterative process, we will refine the eGAP based on input from stakeholders (patients, caregivers, oncologists, nurses, advanced practitioners)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* Age ≥65 years\n* Have a diagnosis of cancer\n* Able to provide informed consent\n* English-speaking (because the platform is currently in English)\n\nInclusion criteria for caregivers:\n\n* Age ≥21 years\n* Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters".\n* Able to provide informed consent\n* English-speaking\n\nInclusion criteria for oncologists:\n\n* Oncologists, APPs, and nurses who care for the patient\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT04824859', 'acronym': 'eGAP', 'briefTitle': 'A Geriatric Assessment Electronic Platform for Older Patients With Cancer (eGAP - Electronic Geriatric Assessment Platform)', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Geriatric Assessment Electronic Platform for Older Patients With Cancer (eGAP - Electronic Geriatric Assessment Platform)', 'orgStudyIdInfo': {'id': 'UCCS21026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'The eGAP consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on patient responses, tailored recommendations will be provided.', 'interventionNames': ['Behavioral: Behavioral']}], 'interventions': [{'name': 'Behavioral', 'type': 'BEHAVIORAL', 'description': 'eGAP that allows patients to complete validated questionnaires, and these questionnaires will be summarized and recommendations provided to the treating team', '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': 'Kah Poh Loh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The data will be available for 7 years from accrual of the first subject.', 'ipdSharing': 'YES', 'description': 'A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Department of Medicine, Hematology/Oncology (SMD)', 'investigatorFullName': 'Kah Poh Loh', 'investigatorAffiliation': 'University of Rochester'}}}}