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

  • STATUS
    Recruiting
  • End date
    Oct 14, 2022
  • participants needed
    300
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 14 April 2021
cyclophosphamide
melphalan
prednisone
cell transplantation
dexamethasone
chemotherapy regimen
bortezomib
revlimid
velcade

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.

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Association of day hospitalization with hospital-at-home, Day hospitalization exclusively
Clinical Study IdentifierNCT03490084
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient > 65 years
Resident of the departments in le-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 le-de-France region
Asymptomatic myeloma
Life expectancy < 6 months
Patient does not understand French language
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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