Clinical trial NCT03490084: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: multiple myeloma
elderly patients
health outcomes
hospital-at-home
day hospitalization
quality of life
medico-economic evaluation
qualitative study
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient aged \> 65 years, with symptomatic multiple myeloma, ineligible for autologous hematopoietic stem-cell transplantation, planned to undergo treatments including bortezomib.

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 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.

Primary outcomes:
measure: Change in Quality of life using questionnaires EORTC QLQ-30
timeFrame: At baseline, at the 6th month and the 12th month
measure: Change in Quality of life using questionnaires EORTC QLQ-MY20
timeFrame: At baseline, at the 6th month and the 12th month
Secondary outcomes:
measure: Survival
timeFrame: At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days)
measure: Multidimensional evaluation of home care
timeFrame: At baseline, at the 6th month
measure: Toxicity of treatment
timeFrame: At baseline, at each evaluation of response to therapy, at the 6th month and the 12th month
measure: family quality of life
timeFrame: At baseline, at the 6th month and the 12th month
measure: Total Cost
timeFrame: At the end of study: 3 years
measure: Fate-to-face interview with patients, caregivers and healthcare staff
timeFrame: At baseline, at the 6th month and the 12th month
Other outcomes:
Locations:
city: Paris
country: France
facility: HAD
state: Île-de-France
Study officials:
affiliation: Hospitalisation à domicile (HAD), APHP
name: Bénédicte MITTAINE-MARZAC, PharmD
role: STUDY_CHAIR
affiliation: Hospitalisation à domicile (HAD), APHP
name: Matthieu de STAMPA, MD
role: STUDY_DIRECTOR
References: