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

NCT03490084 | Unknown

• 2 other identifiers: K160917J2017-A03219-44
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; elderly patients; health outcomes; hospital-at-home; day hospitalization; quality of life; medico-economic evaluation; qualitative study

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Survival

  At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days)

• Multidimensional evaluation of home care

  At baseline, at the 6th month

• Toxicity of treatment

  At baseline, at each evaluation of response to therapy, at the 6th month and the 12th month

• family quality of life

  At baseline, at the 6th month and the 12th month

• Total Cost

  At the end of study: 3 years

Study Arms (2)

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

Day hospitalization exclusively

Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

Other: Day hospitalization exclusively

Interventions

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.

Association of day hospitalization with hospital-at-home

Day hospitalization exclusively OTHER

Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

Day hospitalization exclusively

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

HAD

Paris, Île-de-France Region, 75005, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bénédicte MITTAINE-MARZAC, PharmD

  Hospitalisation à domicile (HAD), APHP

  STUDY CHAIR

• Matthieu de STAMPA, MD

  Hospitalisation à domicile (HAD), APHP

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: April 6, 2018
• Study Start: February 25, 2020
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)