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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Vandœuvre-lès-Nancy, 프랑스, 54500
- CHRU Nancy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cost therapy assessment
기간: 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
기간: 10 months follow-up per patient
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10 months follow-up per patient
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QLQ-C30 questionnaire
기간: 10 months follow-up per patient
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an oncology-specific instrument
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10 months follow-up per patient
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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