Multiple Myeloma
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALQuality of life surveys
Quality of life surveys by EQ-5D and QLQ-C30
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost therapy assessment | 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 | 10 months follow-up per patient | — |
| QLQ-C30 questionnaire | 10 months follow-up per patient | an oncology-specific instrument |
Countries
France
Outcome results
None listed