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

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ClinicalTrials.gov Identifier: NCT03493737
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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
Multiple Myeloma 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 Type : Observational
Estimated Enrollment : 42 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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

Group/Cohort 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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with multiple myeloma requiring a treatment with Bortezomib
Criteria

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

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03493737     History of Changes
Other Study ID Numbers: 2018-A00103-52
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents