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

Multiple Myeloma Clinical Trial

— PAMM-HAD1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03490084
• Other study ID #: K160917J
• Secondary ID: 2017-A03219-44
• Status: Recruiting
• Start date: February 25, 2020
• Est. completion date: October 2023

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Bénédicte MITTAINE-MARZAC, PharmD
• Phone: +33 1 42 34 84 15
• Email: benedicte.mittaine-marzac[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	HAD	Paris	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Survival	All patients will be evaluated in order to collect the following data: death and causality with multiple myeloma, treatments; progression or relapse according to criteria of International Myeloma Working Group; survival without progression, full or partial remission.	At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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