Clinical trial NCT06814405: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Haematological Malignancy
Keywords: hospitalisation
early discharge
domiciliation
supportive therapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: through the duration of study, an average of 2 years
measure: Number of participants in which will be feasible the early discarge mode
timeFrame: through the duration of study, an average of 2 years
Secondary outcomes:
measure: questionnaire patient's quality of life FACT-An (Functional Assessment of Cancer Therapy) (V. 4, scale 0-4)
timeFrame: through the duration of study, an average of 2 years
measure: 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;
timeFrame: through the duration of study, an average of 2 years
measure: rate of optimisation of in-patient places
timeFrame: through the duration of study, an average of 2 years
measure: Rate of Economic Impact
timeFrame: through the duration of study, an average of 2 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS-AOU di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: