Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma (ADHOMY)

Central Hospital, Nancy, France

Status: Completed

Conditions: Multiple Myeloma

Treatments: Behavioral: Quality of life surveys

Study type: Observational

Funder types: Other

Identifiers

NCT03493737

2018-A00103-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

43 participants in 2 patient groups

HaH (Hospital-at-Home)

Description:

Bortezomib is injected at Outpatient hospital at day 1 and at Home at further day of cycles

Treatment:

Behavioral: Quality of life surveys

OH (Outpatient Hospital)

Description:

Bortezomib is always injected at Outpatient hospital

Treatment:

Behavioral: Quality of life surveys