Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06814405
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMICO
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AIL Bologna | OTHER_GRANT | AIL Bologna ODV | View |