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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03219-44 | Registry Identifier | IDRCB |
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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:
This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Association of day hospitalization with hospital-at-home | Other | Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | All patients will be evaluated in order to collect the following data:
| At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Patient aged > 65 years, with symptomatic multiple myeloma, ineligible for autologous hematopoietic stem-cell transplantation, planned to undergo treatments including bortezomib.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bénédicte MITTAINE-MARZAC, PharmD | Contact | +33 1 42 34 84 15 | benedicte.mittaine-marzac@aphp.fr | |
| Matthieu de STAMPA, MD | Contact | +33 1 73 73 59 10 | matthieu.de-stampa@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bénédicte MITTAINE-MARZAC, PharmD | Hospitalisation à domicile (HAD), APHP | Study Chair |
| Matthieu de STAMPA, MD | Hospitalisation à domicile (HAD), APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HAD | Recruiting | Paris | ÃŽle-de-France Region | 75005 | France |
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| Day hospitalization exclusively | Other | Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department. |
|
| 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 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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