Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06814405
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of a Multidisciplinary Programme of Integrated Hospital-home Management With Early Discharge of Patients With Haematological Malignancies Undergoing High-dose Chemotherapy in Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'through the duration of study, an average of 2 years', 'description': 'safety of the early discharge model with home continuation of the care pathway of haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant'}, {'measure': 'Number of participants in which will be feasible the early discarge mode', 'timeFrame': 'through the duration of study, an average of 2 years', 'description': 'feasibility of the early discharge model with home continuation of the care pathway of haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant'}], 'secondaryOutcomes': [{'measure': "questionnaire patient's quality of life FACT-An (Functional Assessment of Cancer Therapy) (V. 4, scale 0-4)", 'timeFrame': 'through the duration of study, an average of 2 years', 'description': "Assessment of the patient's quality of life with questionnaire FACT-An(Functional Assessment of Cancer Therapy) (V. 4, scale 0-4) at early discharge and recovery hematology"}, {'measure': 'Median length of stay with early discharge (outpatient)/median length of hospitalization without early discharge (inpatient) of patients who were enrolled but, for reasons various, were not discharged early;', 'timeFrame': 'through the duration of study, an average of 2 years', 'description': 'Median length of stay with early discharge (outpatient)/median length of hospitalization without early discharge (inpatient) of patients who were enrolled but, for reasons various, were not discharged early;'}, {'measure': 'rate of optimisation of in-patient places', 'timeFrame': 'through the duration of study, an average of 2 years', 'description': 'Assessment of optimisation of in-patient places'}, {'measure': 'Rate of Economic Impact', 'timeFrame': 'through the duration of study, an average of 2 years', 'description': 'Economic Impact Assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hospitalisation', 'early discharge', 'domiciliation', 'supportive therapy'], 'conditions': ['Haematological Malignancy']}, 'descriptionModule': {'briefSummary': "Patients undergoing particular intensive and (sub)myeloablative chemotherapy regimens with subsequent autologous stem cell transplant currently have a relatively low rate of therapy-related complications, both infectious and non-infectious (organ damage), and can therefore benefit from a specific multidisciplinary care programme at home. In this clinical context, early discharge and domicile of the patient after therapy provided in a hospital setting may represent a procedure designed to better intercept the patient's personal needs. In addition, it may make it possible to increase the limited availability of beds in the face of the progressive increase in demand, allowing the provision of hospital therapies to a higher number of patients with a consequent reduction in pre-hospital waiting times.", 'detailedDescription': "Patients undergoing particular intensive and (sub)myeloablative chemotherapy regimes with subsequent autologous stem cell transplant currently have a relatively modest rate of therapy-related complications, of infectious and non-infectious (organ damage), relatively modest, thus being able to benefit of a specific multidisciplinary care programme at home. In this clinical context, the early discharge and domicile of the patient after therapy provided in hospital regimen may represent a procedure designed to better intercept the patient's patient's personal needs. In addition, it may make it possible to increase the limited availability of beds against the progressive increase in demand, allowing the provision of hospital treatment to a higher number of patients with a consequent reduction in pre-admission waiting times. The primary objective of the study is to assess the safety and feasibility of the model of early discharge with home continuation of the care pathway of patients haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant.\n\nThe secondary objectives are as follows:\n\n* Assessment of the patient's quality of life;\n* Evaluation of the impact of the use of innovative remote monitoring technologies;\n* Assessment of the optimisation of in-patient places;\n* Evaluation of the economic impact."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of haematological malignancy undergoing high-dose chemotherapy (sub- or myeloablative)\n* Age between 18-75 years\n* WHO Performance Status \\< 2 or Karnofsky ≥ 60%\n* Adequate organ function:\n* FE≥ 50% and absence of significant electrocardiographic changes\n* eVFG \\> 40 ml/min and/or creatinine ≤ 1.6 mg/dl (CPK-EPI formula)\n* total bilirubin ≤ 3 mg/ml\n* AST/ALT ≤ 5 ULN\n* SpO2 ≥ 94%\n* Reinfusion ≥ 2x106 CD34+/Kg\n* Presence of a 24-hour SARS-COV-2 vaccinated caregiver\n* Home \\< 45 minutes' drive from hospital\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Diagnosis of haematological malignancy at onset or in progression\n* Significant cardiovascular disease: heart failure NYHA class 3 or 4, uncontrolled angina, history of myocardial infarction, unstable angina or stroke in the previous 6 months, uncontrolled hypertension, significant arrhythmias not controlled by medication"}, 'identificationModule': {'nctId': 'NCT06814405', 'acronym': 'AMICO', 'briefTitle': 'Safety and Feasibility of a Multidisciplinary Programme of Integrated Hospital-home Management With Early Discharge of Patients With Haematological Malignancies Undergoing High-dose Chemotherapy in Hospital', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Safety and Feasibility of a Multidisciplinary Programme of Integrated Hospital-home Management With Early Discharge of Patients With Haematological Malignancies Undergoing High-dose Chemotherapy in Hospital', 'orgStudyIdInfo': {'id': 'AMICO'}, 'secondaryIdInfos': [{'id': 'AIL Bologna', 'type': 'OTHER_GRANT', 'domain': 'AIL Bologna ODV'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hospitalized', 'description': 'Hospedalized patients', 'interventionNames': ['Other: Hospital patient management']}, {'type': 'EXPERIMENTAL', 'label': 'early discarged', 'description': 'Early discarged patients', 'interventionNames': ['Procedure: Home patient management']}], 'interventions': [{'name': 'Home patient management', 'type': 'PROCEDURE', 'description': 'with support therapy, Granulocyte growth factor, blood transfusion', 'armGroupLabels': ['early discarged']}, {'name': 'Hospital patient management', 'type': 'OTHER', 'description': 'all procedures and exams needed', 'armGroupLabels': ['hospitalized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+39 0512143680'}, {'name': 'Pier Luigi Zinzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS-AOU di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+39 0512143680'}], 'overallOfficials': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}