Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 主要终点
- Cost of care
研究概览
简要总结
Carfilzomib is administered in treatment of Multiple Myeloma intravenously on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28). With COVID pandemic, the investigators had to limit patient visits to the hospital. The treatment protocols were modified by switching to weekly injections of carfilzomib according to the PLEIADES and ARROW 2 studies.
Considering the frequency of intravenous (IV) administration, home-based chemotherapy in Hospital-at-Home (HaH) setting is an attractive and suitable alternative to standard hospital-based chemotherapy in Outpatient-Hospital (OH), and is expected to provide both cost-savings for the Health Insurance (HI) and improvement in patient quality of life (QoL).
The purpose of the study is to assess the cost-utility of home-based compared to hospital-based carfilzomib administration in multiple myeloma.
The investigators are also planning on assessing healthcare resource utilization and related costs, adverse and intercurrent events, and patients' quality of life and satisfaction, for each strategy.
详细描述
All participants receive the first cycle of treatment in OH. They are then randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services.
For the HaH group, the first injection of each cycle is delivered in OH. The rest of the cycle is delivered at home by HaH after a clinical examination (by nurse or general practitionner).
Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after the end of treatment.
Participants we leave the protocol prematurely in case of treatment failure, toxicity or if participant ask to. For those patients, the end of study visit will be done one month after ending treatment.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •relapsed multiple myeloma, at least one prior line of treatment
- •treatment with carfilzomib validated in a multidisciplinary consultation meeting and accepted by the patient
- •The patient accepts mixed management and benefits from the support of his/her family and friends (see ANAES 2003 criteria). If the patient does not have a caregiver, he/she can still participate in the research and the absence of a caregiver will be collected.
- •Patient capable of adhering to care (cf. ANAES 2003 criteria)
- •Patient affiliated to a social security system or beneficiary of such a system.
- •Patient having received full information on the organization of the research and having signed his or her informed consent
排除标准
- •Person with a contraindication to carfilzomib
- •Women of childbearing age who do not have effective contraception
- •Persons referred to in articles L. 1121-5, L. 1121-7; L1121-8 and L1122-1-2 of the Public Health Code
- •Pregnant woman, parturient or nursing mother
- •Minor (not emancipated)
- •Adult person under a legal protection measure (guardianship, curatorship, safeguard of justice)
- •A person of full age who is unable to express his or her consent
结局指标
主要结局
Cost of care
时间窗: Up to 20 month
Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection
Differences of quality of life in myeloma patients between each group
时间窗: Up to 20 months
Difference of quality of life according to EORTC QLQ-MY20 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 20 questions related to myeloma symptoms, answer from 1 to 4, 1 being the best state with no problem)
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
时间窗: Up to 20 months
Incremental cost-utility ratio (ICUR) of home-based compared to hospital-based carfilzomib administration in multiple myeloma, expressed in euros per QALY according to EQ-5D-5L questionnaire (EuroQOL 5 dimensions 5 levels) from 0 to 1 (1 being the best state with no problem)
Differences of quality of life in cancer patients between each group
时间窗: Up to 20 months
Difference of quality of life according to EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 30 questions, answer from 1 to 4, 1 being the best state with no problem)
次要结局
- Healthcare resource utilization(Up to 20 months)
- Adverse events related to myeloma treatment(Up to 20 months)
- Patients and caregivers' satisfaction(Up to 20 months)
研究者
Pierre FEUGIER
Professor
Central Hospital, Nancy, France