Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

Multiple Myeloma Clinical Trial

— ADHOMY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493737
• Other study ID #: 2018-A00103-52
• Status: Completed
• Start date: April 10, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: August 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 15, 2020
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Behavioral:
• Quality of life surveys
Quality of life surveys by EQ-5D and QLQ-C30

Locations

Country	Name	City	State
France	CHRU Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	EQ-5D questionnaire		10 months follow-up per patient
Primary	QLQ-C30 questionnaire	an oncology-specific instrument	10 months follow-up per patient