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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Other: Day hospitalization exclusively; Other: Association of day hospitalization with hospital-at-home

Study type: Observational

Funder types: Other

Identifiers

NCT03490084

K160917J

2017-A03219-44 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Association of day hospitalization with hospital-at-home

Description:

Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.

Treatment:

Other: Association of day hospitalization with hospital-at-home

Day hospitalization exclusively

Description:

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

Treatment:

Other: Day hospitalization exclusively