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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
hospitalized
Hospedalized patients
干预措施: Hospital patient management (Other)
early discarged
Early discarged patients
干预措施: Home patient management (Procedure)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: through the duration of study, an average of 2 years
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
Number of participants in which will be feasible the early discarge mode
时间窗: through the duration of study, an average of 2 years
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
次要结局
- Rate of Economic Impact(through the duration of study, an average of 2 years)
- 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)