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

Обзор

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.

Подробное описание

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.

The secondary objectives are as follows:

* Assessment of the patient's quality of life; * Evaluation of the impact of the use of innovative remote monitoring technologies; * Assessment of the optimisation of in-patient places; * Evaluation of the economic impact.

Вмешательства

• Процедура Home patient management
  with support therapy, Granulocyte growth factor, blood transfusion
• Другое Hospital patient management
  all procedures and exams needed

Первичные конечные точки

• Number of participants with treatment-related adverse events [Срок оценки: through the duration of study, an average of 2 years]
• Number of participants in which will be feasible the early discarge mode [Срок оценки: through the duration of study, an average of 2 years]

Вторичные конечные точки (4)

• questionnaire patient's quality of life FACT-An (Functional Assessment of Cancer Therapy) (V. 4, scale 0-4) [Срок оценки: through the duration of study, an average of 2 years]
• 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; [Срок оценки: through the duration of study, an average of 2 years]
• rate of optimisation of in-patient places [Срок оценки: through the duration of study, an average of 2 years]
• Rate of Economic Impact [Срок оценки: through the duration of study, an average of 2 years]

Критерии участия

Критерии включения

• Diagnosis of haematological malignancy undergoing high-dose chemotherapy (sub- or myeloablative)
• Age between 18-75 years
• WHO Performance Status < 2 or Karnofsky ≥ 60%
• Adequate organ function:
• FE≥ 50% and absence of significant electrocardiographic changes
• eVFG > 40 ml/min and/or creatinine ≤ 1.6 mg/dl (CPK-EPI formula)
• total bilirubin ≤ 3 mg/ml
• AST/ALT ≤ 5 ULN
• SpO2 ≥ 94%
• Reinfusion ≥ 2x106 CD34+/Kg
• Presence of a 24-hour SARS-COV-2 vaccinated caregiver
• Home < 45 minutes' drive from hospital
• Informed consent obtained

Критерии исключения

• Diagnosis of haematological malignancy at onset or in progression
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• IRCCS-AOU di Bologna — Bologna

Идентификаторы

NCT: NCT06814405 · AMICO · AIL Bologna

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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