Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cost-Utility Evaluation Comparing Hospital Versus Home-Based Bortezomib in Multiple Myeloma: The ADHOMY Study

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Behavioral: Quality of life surveys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HaH (Hospital-at-Home)<br>Bortezomib is injected at Outpatient hospital at day 1 and at Home at further day of cycles | Behavioral: Quality of life surveys<br>* Quality of life surveys by EQ-5D and QLQ-C30<br>|
| OH (Outpatient Hospital)<br>Bortezomib is always injected at Outpatient hospital | Behavioral: Quality of life surveys<br>* Quality of life surveys by EQ-5D and QLQ-C30<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost therapy assessment | Cost therapy assessment including direct medical costs, non-medical costs and indirect costs, investigated from the French Health Insurance perspective and expressed in Euro. | 10 months follow-up per patient | 
| EQ-5D questionnaire |  | 10 months follow-up per patient | 
| QLQ-C30 questionnaire | an oncology-specific instrument | 10 months follow-up per patient |