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ADHOMY: Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT03493737
Collaborator
(none)
43
Enrollment
1
Location
22.2
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Quality of life surveys

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.

Study Design

Study Type:
Observational
Actual Enrollment :
43 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Cost-Utility Evaluation Comparing Hospital Versus Home-Based Bortezomib in Multiple Myeloma: The ADHOMY Study
Actual Study Start Date :
Apr 10, 2018
Actual Primary Completion Date :
Aug 15, 2019
Actual Study Completion Date :
Feb 15, 2020

Arms and Interventions

Arm Intervention/Treatment
HaH (Hospital-at-Home)

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

Behavioral: Quality of life surveys
Quality of life surveys by EQ-5D and QLQ-C30
OH (Outpatient Hospital)

Bortezomib is always injected at Outpatient hospital

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. EQ-5D questionnaire [10 months follow-up per patient]

  3. QLQ-C30 questionnaire [10 months follow-up per patient]

    an oncology-specific instrument

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU Nancy Vandœuvre-lès-Nancy France 54500

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT03493737
Other Study ID Numbers:
  • 2018-A00103-52
First Posted:
Apr 10, 2018
Last Update Posted:
Aug 17, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 17, 2020