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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Home patient management

    Procedure/Surgery

    with support therapy, Granulocyte growth factor, blood transfusion

  • Hospital patient management

    Other intervention

    all procedures and exams needed

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: hospitalizedActive comparator 1 intervention
Group B: early discargedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
through the duration of study, an average of 2 years
2

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

Time frame
through the duration of study, an average of 2 years

Secondary outcomes

1

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

Time frame
through the duration of study, an average of 2 years
2

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;

Time frame
through the duration of study, an average of 2 years
3

rate of optimisation of in-patient places

Assessment of optimisation of in-patient places

Time frame
through the duration of study, an average of 2 years
4

Rate of Economic Impact

Economic Impact Assessment

Time frame
through the duration of study, an average of 2 years

Other outcomes

Sponsors and contacts

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