About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of haematological malignancy undergoing high-dose chemotherapy (sub- or myeloablative)
Age between 18-75 years
WHO Performance Status < 2 or Karnofsky ≥ 60%
FE≥ 50% and absence of significant electrocardiographic changes
Disqualifiers
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
Parallel
Treatments tested in this trial
Home patient management
Procedure/Surgerywith support therapy, Granulocyte growth factor, blood transfusion
Hospital patient management
Other interventionall procedures and exams needed
Treatment groups
Trial outcomes
Primary outcomes
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
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
Secondary outcomes
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
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;
rate of optimisation of in-patient places
Assessment of optimisation of in-patient places
Rate of Economic Impact
Economic Impact Assessment
Sponsors and contacts
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