Skip to main content
OpenTrials
Completed

NCT Number: NCT03493737

Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life surveys

Behavioral

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

Primary outcomes

  1. Cost therapy assessment

    Time frame: 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.

  2. EQ-5D questionnaire

    Time frame: 10 months follow-up per patient

  3. QLQ-C30 questionnaire

    Time frame: 10 months follow-up per patient

    an oncology-specific instrument

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ADHOMY

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 10, 2018
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.