Haematological Malignancy
Conditions
Keywords
hospitalisation, early discharge, domiciliation, supportive therapy
Brief summary
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.
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.
Interventions
PROCEDUREHome patient management
with support therapy, Granulocyte growth factor, blood transfusion
OTHERHospital patient management
all procedures and exams needed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | through the duration of study, an average of 2 years | 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 |
| Number of participants in which will be feasible the early discarge mode | through the duration of study, an average of 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire patient's quality of life FACT-An (Functional Assessment of Cancer Therapy) (V. 4, scale 0-4) | through the duration of study, an average of 2 years | 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 |
| 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 | 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; |
| rate of optimisation of in-patient places | through the duration of study, an average of 2 years | Assessment of optimisation of in-patient places |
| Rate of Economic Impact | through the duration of study, an average of 2 years | Economic Impact Assessment |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Outcome results
None listed