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
1 other identifier
observational
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedStudy Start
First participant enrolled
April 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2020
CompletedAugust 17, 2020
August 1, 2020
1.3 years
April 3, 2018
August 13, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
HaH (Hospital-at-Home)
Bortezomib is injected at Outpatient hospital at day 1 and at Home at further day of cycles
OH (Outpatient Hospital)
Bortezomib is always injected at Outpatient hospital
Interventions
Quality of life surveys by EQ-5D and QLQ-C30
Eligibility Criteria
Patients with multiple myeloma requiring a treatment with Bortezomib
You may qualify if:
- 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
You may not qualify if:
- Already participating in another trial
- Have a follow-up and/or treatment for another condition requiring a particular care during the Bortezomib treatment period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Nancy
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 10, 2018
Study Start
April 10, 2018
Primary Completion
August 15, 2019
Study Completion
February 15, 2020
Last Updated
August 17, 2020
Record last verified: 2020-08