Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 17
- 主要终点
- Ambulatory medical assistance efficiency
研究概览
简要总结
The emergence of targeted therapy (ibrutinib, venetoclax, acalabrutinib) has revolutionized the management practices of chronic lymphoid leukemia due to their effectiveness. However, targeted therapy induces a significant additional cost compared to treatment with immunochemotherapy and their use can be problematic due to the frequent occurrence of side effects, which can be serious. In order to improve the current management of patients treated with targeted therapy, the aim of this study is to evaluate the ambulatory medical assistance nurse program. Ambulatory medical assistance is based on regular telephone calls to patient's homes by a specialist nurse and consists of the monitoring, detection and early management of possible adverse effects of targeted therapy, in link with the hematologist. The main objective of this clinical research is to determine efficiency of the ambulatory medical assistance nurse program.
详细描述
This research is a prospective randomized multicenter comparative study in 2 parallel groups (1: 1) : patients benefiting from the ambulatory medical assistance nurse program in addition to conventional care versus patients benefiting from conventional care. For each patient, data will be collected during 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over the age of 18
- •Patients with chronic lymphoid leukemia and starting treatment with targeted therapy: ibrutinib, venetoclax or acalabrutinib, alone or in combination with obinutuzumab or rituximab in 1L or R/R according to the indications of the Marketing Authorization.
- •Be able to understand the objective and the constraints related to the research
- •Patient having signed the consent form
- •Patient with Social Security affiliation or equivalent
- •Person able to speak on the phone
排除标准
- •Patient who has already benefited from ambulatory medical assistance nurse program with a previous treatment
- •Pregnant women
- •Patients under judicial protection
结局指标
主要结局
Ambulatory medical assistance efficiency
时间窗: 1 year
To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L
次要结局
- Quality of life of patients(at inclusion, 1 and 2 years after initiation of targeted therapy)
- Cost-effectiveness analysis(at 1 and 2 years)
- Survival of patients(1 and 2 years after initiation of targeted therapy)