Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma (ADHOMY)
Cost-Utility Evaluation Comparing Hospital Versus Home-Based Bortezomib in Multiple Myeloma: The ADHOMY Study
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Vandœuvre-lès-Nancy、法国、54500
- CHRU NANCY
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Already participating in another trial
- Have a follow-up and/or treatment for another condition requiring a particular care during the Bortezomib treatment period
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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HaH (Hospital-at-Home)
Bortezomib is injected at Outpatient hospital at day 1 and at Home at further day of cycles
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Quality of life surveys by EQ-5D and QLQ-C30
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OH (Outpatient Hospital)
Bortezomib is always injected at Outpatient hospital
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Quality of life surveys by EQ-5D and QLQ-C30
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cost therapy assessment
大体时间：10 months follow-up per patient
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Cost therapy assessment including direct medical costs, non-medical costs and indirect costs, investigated from the French Health Insurance perspective and expressed in Euro.
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10 months follow-up per patient
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EQ-5D questionnaire
大体时间：10 months follow-up per patient
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10 months follow-up per patient
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QLQ-C30 questionnaire
大体时间：10 months follow-up per patient
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an oncology-specific instrument
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10 months follow-up per patient
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.