Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-04-21 @ 11:51 AM
Study NCT ID:
NCT03196050
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemonitoring of Geriatric Cancer Patients Using Handheld Devices
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-21', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Adherence/Compliance', 'timeFrame': '1 Year', 'description': 'Frequency of using the handheld device and of daily/weekly/monthly reportings'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '1 Year', 'description': 'Assessed using the EORTC QLQ-C30 questionnaire'}, {'measure': 'Reliability of reports', 'timeFrame': '1 Year', 'description': 'Patient-reported status will be compared to physician-rated status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '31740981', 'type': 'DERIVED', 'citation': 'Buergy D, Siefert V, Neumaier C, Ganslandt T, Sperk E, Blessing M, Hesser J, Welzel G, Wenz F, Giordano FA. Prospective trial on telemonitoring of geriatric cancer patients using handheld devices. Strahlenther Onkol. 2020 Mar;196(3):205-212. doi: 10.1007/s00066-019-01548-0. Epub 2019 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'Cancer is becoming a chronic disease, with the requirement of a lifelong intake of cancer-controlling drugs. While young(er) patients may cope with this, geriatric cancer patients may require a more customized and tailored follow up.\n\nMost elderly patients have multiple other diseases ("comorbidities") and, due to many other factors, may per se not tolerate or simply not follow anticancer therapies. This may not only impair quality of life (QoL), but on the long rung also the therapeutic outcome (survival).\n\nHandheld devices provide a new reporting/communication tool for patients and health care providers. TeleGraPH will assess if these devices are a suitable communication modality in a cohort of geriatric cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 60 years\n* Karnofsky Performance Status ≥ 70\n* histologically confirmed malignant tumor (cancer)\n\nExclusion Criteria:\n\n* concurrent severe and/or uncontrolled concomitant medical conditions\n* Patients unwilling or unable to comply with using a handheld device'}, 'identificationModule': {'nctId': 'NCT03196050', 'briefTitle': 'Telemonitoring of Geriatric Cancer Patients Using Handheld Devices', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Telemonitoring of Geriatric Cancer Patients Using Handheld Devices (TeleGraPH)', 'orgStudyIdInfo': {'id': 'TeleGraPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemonitoring using a handheld device', 'description': 'Patients will be euqipped with either an app or a handheld device with a pre-installed app to communicate with the coordinating center.', 'interventionNames': ['Device: Handheld Device (Smart Phone)']}], 'interventions': [{'name': 'Handheld Device (Smart Phone)', 'type': 'DEVICE', 'description': 'Handheld device will be used for 3 tasks:\n\n1x per day: status update ("how are you today"?)\n\n1x per week: 10 questions on general health status\n\n1x per month: EORTC QLQ-C30 questionnaire', 'armGroupLabels': ['Telemonitoring using a handheld device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Department of Radiotherapy University Hospital Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hector-Stiftung', 'class': 'OTHER'}, {'name': 'humediQ global GmbH, Grünwald', 'class': 'UNKNOWN'}, {'name': 'Vitaphone GmbH, Mannheim', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Chief Medical Officer', 'investigatorFullName': 'Frederik Wenz', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}