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

NCT06814405 | Recruiting

• 2 other identifiers: AMICOAIL Bologna
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Haematological Malignancy

Keywords

hospitalisation; early discharge; domiciliation; supportive therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• 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

  through the duration of study, an average of 2 years

• Rate of Economic Impact

  through the duration of study, an average of 2 years

Study Arms (2)

hospitalized

ACTIVE COMPARATOR

Hospedalized patients

Other: Hospital patient management

early discarged

EXPERIMENTAL

Early discarged patients

Procedure: Home patient management

Interventions

Home patient management PROCEDURE

with support therapy, Granulocyte growth factor, blood transfusion

early discarged

Hospital patient management OTHER

all procedures and exams needed

hospitalized

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS-AOU di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+39 0512143680; pierluigi.zinzani@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 7, 2025
• Study Start: May 11, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)