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 (AMICO)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Haematological Malignancy

Treatments: Procedure: Home patient management; Other: Hospital patient management

Study type: Interventional

Funder types: Other

Identifiers

NCT06814405

AMICO

AIL Bologna (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

hospitalized

Active Comparator group

Description:

Hospedalized patients

Treatment:

Other: Hospital patient management

early discarged

Experimental group

Description:

Early discarged patients

Treatment:

Procedure: Home patient management