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)

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.

Study Overview

• Status: Recruiting
• Conditions: Haematological Malignancy
• Intervention / Treatment: Other: Hospital patient management; Procedure: Home patient management

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pier Luigi Zinzani, MD; Phone Number: +39 0512143680; Email: pierluigi.zinzani@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS-AOU di Bologna
    • Contact: Pier Luigi Zinzani, MD; Phone Number: +39 0512143680; Email: pierluigi.zinzani@unibo.it
    • Contact: Pier Luigi Zinzani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: hospitalized; Hospedalized patients	Other: Hospital patient management; all procedures and exams needed
Experimental: early discarged; Early discarged patients	Procedure: Home patient management; with support therapy, Granulocyte growth factor, blood transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	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	through the duration of study, an average of 2 years
Number of participants in which will be feasible the early discarge mode	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	through the duration of study, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire patient's quality of life FACT-An (Functional Assessment of Cancer Therapy) (V. 4, scale 0-4)	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	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;	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;	through the duration of study, an average of 2 years
rate of optimisation of in-patient places	Assessment of optimisation of in-patient places	through the duration of study, an average of 2 years
Rate of Economic Impact	Economic Impact Assessment	through the duration of study, an average of 2 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: supportive therapy; early discharge; hospitalisation; domiciliation
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: AMICO; AIL Bologna (Other Grant/Funding Number: AIL Bologna ODV)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No