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Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma (PAMM-HAD1)

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ClinicalTrials.gov Identifier: NCT03490084
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Multiple Myeloma Other: Association of day hospitalization with hospital-at-home Other: Day hospitalization exclusively

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma
Actual Study Start Date : February 25, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.
Other: Day hospitalization exclusively
Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.




Primary Outcome Measures :
  1. Change in Quality of life using questionnaires EORTC QLQ-30 [ Time Frame: At baseline, at the 6th month and the 12th month ]
    Comparison of quality of life using questionnaires EORTC QLQ-30.

  2. Change in Quality of life using questionnaires EORTC QLQ-MY20 [ Time Frame: At baseline, at the 6th month and the 12th month ]
    Comparison of quality of life using questionnaires EORTC QLQ-MY20.


Secondary Outcome Measures :
  1. Survival [ Time Frame: At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days) ]

    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.

  2. Multidimensional evaluation of home care [ Time Frame: At baseline, at the 6th month ]
    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.

  3. Toxicity of treatment [ Time Frame: At baseline, at each evaluation of response to therapy, at the 6th month and the 12th month ]
    This evaluation will be performed for all patients with the National Cancer Institute Common Terminology Criteria for Adverse Events (CRCAE version 3.0).

  4. family quality of life [ Time Frame: At baseline, at the 6th month and the 12th month ]
    Family quality of life will be evaluated with Zarit Burden Inventory

  5. Total Cost [ Time Frame: At the end of study: 3 years ]
    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.

  6. Fate-to-face interview with patients, caregivers and healthcare staff [ Time Frame: At baseline, at the 6th month and the 12th month ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490084


Contacts
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Contact: Bénédicte MITTAINE-MARZAC, PharmD +33 1 42 34 84 15 benedicte.mittaine-marzac@aphp.fr
Contact: Matthieu de STAMPA, MD +33 1 73 73 59 10 matthieu.de-stampa@aphp.fr

Locations
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France
HAD Recruiting
Paris, Île-de-France, France, 75005
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Bénédicte MITTAINE-MARZAC, PharmD Hospitalisation à domicile (HAD), APHP
Study Director: Matthieu de STAMPA, MD Hospitalisation à domicile (HAD), APHP

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03490084    
Other Study ID Numbers: P_PREPS 16-596
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
multiple myeloma
elderly patients
health outcomes
hospital-at-home
day hospitalization
quality of life
medico-economic evaluation
qualitative study
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases