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Spots Global Cancer Trial Database for Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma

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Trial Identification

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

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

Study ID: NCT03490084

Study Description

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.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

HAD, Paris, Île-de-France, France

Contact Details

Name: Bénédicte MITTAINE-MARZAC, PharmD

Affiliation: Hospitalisation à domicile (HAD), APHP

Role: STUDY_CHAIR

Name: Matthieu de STAMPA, MD

Affiliation: Hospitalisation à domicile (HAD), APHP

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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