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

NCT ID: NCT03490084

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-25
• Study Completion Date: 2023-10-31

Brief Summary

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.

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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Association of day hospitalization with hospital-at-home

Intervention Type: OTHER

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.

Day hospitalization exclusively

Intervention Type: OTHER

Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

Interventions

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.

Intervention Type: OTHER

Day hospitalization exclusively

Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bénédicte MITTAINE-MARZAC, PharmD

Role: STUDY_CHAIR

Hospitalisation à domicile (HAD), APHP

Matthieu de STAMPA, MD

Role: STUDY_DIRECTOR

Hospitalisation à domicile (HAD), APHP

Locations

HAD

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Bénédicte MITTAINE-MARZAC, PharmD

Role: CONTACT

benedicte.mittaine-marzac@aphp.fr

+33 1 42 34 84 15

Matthieu de STAMPA, MD

Role: CONTACT

matthieu.de-stampa@aphp.fr

+33 1 73 73 59 10

Other Identifiers

2017-A03219-44

Identifier Type: REGISTRY

Identifier Source: secondary_id

K160917J

Identifier Type: -

Identifier Source: org_study_id