Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma (PAMM-HAD1)

The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.

As secondary objectives, the study aims to compare the impacts of the two types of care organization on:

• the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
• psychological status of patients,
• specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
• health outcomes,
• the caregiver's burden,

This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: Association of day hospitalization with hospital-at-home; Other: Day hospitalization exclusively

Detailed Description

Multiple myeloma, a malignant blood disease with about 5000 new cases diagnosed annually in France, essentially in the elderly population, is associated with alteration of quality of life resulting from pathology and therapies.

Multiples cycles of chemotherapies are administered in a regular manner, as outpatient treatment or day hospitalization.

In this study aiming to explore the impacts on health outcomes and resources utilization of hospital-at-home for elderly patients with multiple myeloma, all patients will be treated by 4 standardized protocols of treatment including bortezomib by subcutaneous administration.

9 centers will participate to the study. The study will not change the usual practices of care of these centers:

• 6 centers organize patient care through day hospitalization combined with hospital-at-home,
• 3 other centers rely exclusively on day hospitalization.

The study will target overall the inclusion of 300 patients for the 9 centers and 70 participants (35 for each arm: 10 patients, 10 caregivers, 15 from healthcare team) for the qualitative study.

The individual follow up of each patient will last 12 months. The patient's vital status will be documented at the 24th month.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Bénédicte MITTAINE-MARZAC, PharmD; Phone Number: +33 1 42 34 84 15; Email: benedicte.mittaine-marzac@aphp.fr
• Study Contact Backup: Name: Matthieu de STAMPA, MD; Phone Number: +33 1 73 73 59 10; Email: matthieu.de-stampa@aphp.fr

Study Locations

• France
  • Île-de-France
    • Paris, Île-de-France, France, 75005
      • Recruiting
      • HAD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient aged > 65 years, with symptomatic multiple myeloma, ineligible for autologous hematopoietic stem-cell transplantation, planned to undergo treatments including bortezomib.

Description

Inclusion Criteria:

• Patient > 65 years;
• Resident of the departments in Île-de-France region (75, 92, 93 and 94);
• Symptomatic multiple myeloma (relapsed or no);
• Patient planned to receive one of the following chemotherapy protocols including bortezomib (VELCADE®): VMP (Velcade, Melphalan, Prednisone), VCD (Velcade, Cyclophosphamide, Dexamethasone), VelDex (Velcade, Dexamethasone), VRD (Velcade, Revlimid, Dexamethasone);
• Ineligible for autologous hematopoietic stem-cell transplantation (ASCT);
• Covered by a health insurance;
• Patient who does not oppose to the use of his/her medical data for the purpose of clinical research.
• Adult patients under guardianship will can be enrolled in the study, a consent of tutor is needed completed by patient's consent.

Exclusion Criteria:

• Resident of the departments of 77, 78 and 91 in Île-de-France region;
• Asymptomatic myeloma;
• Life expectancy < 6 months;
• Patient does not understand French language.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Association of day hospitalization with hospital-at-home; Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.	Other: Association of day hospitalization with hospital-at-home; Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.
Day hospitalization exclusively; Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.	Other: Day hospitalization exclusively; Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of life using questionnaires EORTC QLQ-30	Comparison of quality of life using questionnaires EORTC QLQ-30.	At baseline, at the 6th month and the 12th month
Change in Quality of life using questionnaires EORTC QLQ-MY20	Comparison of quality of life using questionnaires EORTC QLQ-MY20.	At baseline, at the 6th month and the 12th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	All patients will be evaluated in order to collect the following data: death and causality with multiple myeloma, treatments;; progression or relapse according to criteria of International Myeloma Working Group;; survival without progression, full or partial remission.	At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days)
Multidimensional evaluation of home care	RAI-HC (Resident Assessment Instrument Home Care) will be used at home. Multidimensional evaluation involves 19 areas such as sociodemographic, environmental and clinical endpoints with psychological status, cognitive status, morbidity and medication compliance defined by validated synthetic clinical scales.	At baseline, at the 6th month
Toxicity of treatment	This evaluation will be performed for all patients with the National Cancer Institute Common Terminology Criteria for Adverse Events (CRCAE version 3.0).	At baseline, at each evaluation of response to therapy, at the 6th month and the 12th month
family quality of life	Family quality of life will be evaluated with Zarit Burden Inventory	At baseline, at the 6th month and the 12th month
Total Cost	The following costs will be collected: hospitalization, home care, transport, biological exams, costs of chemotherapy (bortezomib) as well as indirect costs such as paid sick leave and salary of caregiver at home.	At the end of study: 3 years
Fate-to-face interview with patients, caregivers and healthcare staff	The assessment criteria are the quality care, the continuity of care, the coordination between the care actors, the information transmission, the incentives and the barriers according to the forms of hospitalization.	At baseline, at the 6th month and the 12th month

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Bénédicte MITTAINE-MARZAC, PharmD, Hospitalisation à domicile (HAD), APHP; Study Director: Matthieu de STAMPA, MD, Hospitalisation à domicile (HAD), APHP

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; multiple myeloma; qualitative study; elderly patients; health outcomes; hospital-at-home; day hospitalization; medico-economic evaluation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: K160917J; 2017-A03219-44 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No