Cost-Utility Evaluation Comparing Hospital Versus Home-Based Bortezomib in Multiple Myeloma: The ADHOMY Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- QLQ-C30 questionnaire
研究概览
简要总结
Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.
This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France.
详细描述
Bortezomib is a standard therapy of newly-diagnosed multiple myeloma and is also approved for relapsing disease, requiring the patients to travel to the outpatient-hospital (OH) once a week for several months. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.
This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France: exclusive hospital-based Bortezomib administration versus combined administration in both OH and HaH.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Minimum age 18
- •Enrolled in a social security scheme
- •Diagnosis of multiple myeloma in first line or relapse
- •Treatment plan including Bortezomib, adopted in a multidisciplinary meeting in a department of Hematology in Nancy (main investigator), Reims, Strasbourg University Hospitals or Metz-Thionville and Mulhouse local state-run hospitals
- •The patients must have agreed to the treatment protocol and to take IV or PO associated drugs prescribed in addition to Bortezomib
- •The patients must meet the 2003 eligibility criteria of the National Agency for Accreditation and Evaluation in Health (ANAES) for chemotherapy at home:
- •Absence of severe adaptive or psychological disorders, ability to understand the protocol
- •Absence of cognitive impairment
- •Availability and agreement of the attending physician
- •Home safety and hygiene
- •Do not decline to participate in the research and share their personal data
排除标准
- •Already participating in another trial
- •Have a follow-up and/or treatment for another condition requiring a particular care during the Bortezomib treatment period
结局指标
主要结局
QLQ-C30 questionnaire
时间窗: 10 months follow-up per patient
an oncology-specific instrument
Cost therapy assessment
时间窗: 10 months follow-up per patient
Cost therapy assessment including direct medical costs, non-medical costs and indirect costs, investigated from the French Health Insurance perspective and expressed in Euro.
EQ-5D questionnaire
时间窗: 10 months follow-up per patient
次要结局
未报告次要终点