Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

NCT ID: NCT03493737

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-10

Study Completion Date

2020-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HaH (Hospital-at-Home)

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

Quality of life surveys

Intervention Type BEHAVIORAL

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

OH (Outpatient Hospital)

Bortezomib is always injected at Outpatient hospital

Quality of life surveys

Intervention Type BEHAVIORAL

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

Interventions

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Quality of life surveys

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2018-A00103-52

Identifier Type: -

Identifier Source: org_study_id

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