Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT03425435
Status:
TERMINATED
Last Update Posted:
2022-02-01
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Care of Oncological Patients With HPN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}, {'id': 'D006302', 'term': 'Health Services Research'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'preterm stop due to low recruitment numbers during and still ongoing pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient´s questionnaire', 'timeFrame': 'Outcome measures obtained 1, 4 and 12 weeks after discharge from hospital', 'description': 'Mean changes in total scores of QoL-questionnaire from baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tumors and Home Parenteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '39612012', 'type': 'DERIVED', 'citation': 'Schneider A, Baur C, Zopf Y, Torok HP, Sina C, Prinz C, Monnich H, Madisch A, Maluck-Scholecke S, Rotzer I, Seipt C, Gotte A, Beer J, Jager E. Quality of care of oncological patients with home parenteral nutrition. Support Care Cancer. 2024 Nov 29;32(12):834. doi: 10.1007/s00520-024-09011-2.'}]}, 'descriptionModule': {'briefSummary': 'Medical care for patients with home parenteral nutrition (HPN) is challenging. Among other aspects, the transition from the inpatient to the outpatient setting (discharge management), the organization of HPN at home or in a care facility (care management), the expertise required to care for patients with HPN and consistent compliance with standards are key to the quality of care for patients requiring HPN.\n\nHospital patients on parenteral nutrition (PN) to be continued at home are often discharged at very short notice. A good interlocking of all players is required to collect and distribute the relevant information, to secure proper training for those involved and to have all utilities and equipment at hand when the patient arrives.\n\nThis study collects nutritional and clinical parameters (including patient-reported parameters) along the continuum of care of HPN patients to evaluate the impact of the quality of care of HPN patients on their quality of life.', 'detailedDescription': 'The HPN management will be evaluated by using a self-developed patient and a standardized quality of life questionnaire.\n\nPatients will be recruited at the participating hospital by their treating physician before discharge and will continue their study participation after discharge.\n\nThe documentation period for the individual patients will be 3 months.\n\nThe questions of the patient´s questionnaire cover areas of interest like: satisfaction with discharge management, nutrition, satisfaction with HPN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with solid tumors with indication for home parenteral nutrition.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women with an initial prescription for HPN during the current hospital stay\n* Planned PN must at least contain the macronutrients glucose and amino acids.\n* Solid, malignant tumor\n* Anticipated duration of the HPN is at least 28 days\n* Age ≥18 years\n* Full legal capacity or legal guardian available\n* Fluent in German language\n* Able to read and write in German language\n* Signed patient informed consent form\n* Indication for PN\n\nExclusion Criteria:\n\n* Contraindication for PN\n* ECOG performance status \\>3\n* Pregnant and breast-feeding women\n* Concurrent participation in another clinical study that requires deviations from the hospital's routine PN, nutrition and/or nursing procedures"}, 'identificationModule': {'nctId': 'NCT03425435', 'acronym': 'VHPE-S', 'briefTitle': 'Quality of Care of Oncological Patients With HPN', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Quality of Care of Oncological Patients With Home Parenteral Nutrition', 'orgStudyIdInfo': {'id': 'HPNM-001-CNI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'QoL and developed questionnaires for healthcare research', 'type': 'OTHER', 'description': 'Questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30623', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Andrea Schneider, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}