Home management program for patients with blood cancers after chemotherapy
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
NA · IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06814405
This study tests a new home care program for patients with blood cancers after high-dose chemotherapy to see if it helps them recover better while allowing them to leave the hospital sooner.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06814405 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of a multidisciplinary care program that allows patients with haematological malignancies to be discharged early from the hospital and continue their treatment at home. The program targets patients undergoing high-dose chemotherapy and aims to address their personal needs while optimizing hospital bed availability. The study will assess various outcomes, including patient quality of life, the effectiveness of remote monitoring technologies, and the economic impact of this approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of haematological malignancy undergoing high-dose chemotherapy and who meet specific health criteria.
Not a fit: Patients with progressing haematological malignancies or significant cardiovascular diseases may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could enhance patient comfort and recovery while improving hospital resource management.
How similar studies have performed: Other studies have shown promising results with similar home management approaches for patients undergoing intensive treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, Bologna
- IRCCS-AOU di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Pier Luigi Zinzani, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Pier Luigi Zinzani, MD
- Email: pierluigi.zinzani@unibo.it
- Phone: +39 0512143680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Haematological Malignancy, hospitalisation, early discharge, domiciliation, supportive therapy