Cost-Utility Analysis Hospital Versus Home in Multiple My... | NCT03493737

Studies
Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma

NCT03493737

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Aug 17, 2020Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Quality of life surveys

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2018Actual

Primary Completion Date

Aug 15, 2019Actual

Completion Date

Feb 15, 2020Actual

First Submitted Date

Apr 3, 2018

First Submission Date that Met QC Criteria

Apr 9, 2018

First Posted Date

Apr 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2020

Last Update Posted Date

Aug 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
OH (Outpatient Hospital)		Bortezomib is always injected at Outpatient hospital	Behavioral: Quality of life surveys

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quality of life surveys	Behavioral	Quality of life surveys by EQ-5D and QLQ-C30	HaH (Hospital-at-Home) OH (Outpatient Hospital)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cost therapy assessment	Cost therapy assessment including direct medical costs, non-medical costs and indirect costs, investigated from the French Health Insurance perspective and expressed in Euro.	10 months follow-up per patient
EQ-5D questionnaire		10 months follow-up per patient
QLQ-C30 questionnaire	an oncology-specific instrument	10 months follow-up per patient

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with multiple myeloma requiring a treatment with Bortezomib

Sampling Method

Non-Probability Sample

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders