Comparing hospital-at-home care to day hospitalization for elderly patients with multiple myeloma
Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma
This study is testing whether elderly patients with multiple myeloma do better with a mix of day hospitalization and care at home compared to just day hospitalization alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, Cyclophosphamide, Prednisone |
| Locations | 1 site (Paris, Île-de-France) |
| Trial ID | NCT03490084 on ClinicalTrials.gov |
What this trial studies
This study compares the health outcomes and resource utilization of two care approaches for elderly patients with multiple myeloma: day hospitalization alone versus a combination of day hospitalization and hospital-at-home care. It aims to evaluate overall survival adjusted for quality of life, psychological status, treatment-related toxicities, and caregiver burden. The study will include 300 patients across 9 centers in the Île-de-France region, with a follow-up period of 12 months for each patient. Additionally, qualitative assessments will explore the incentives and barriers to these care models.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 65 years old with symptomatic multiple myeloma who are not eligible for autologous hematopoietic stem-cell transplantation.
Not a fit: Patients with asymptomatic myeloma or those with a life expectancy of less than 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and survival rates for elderly patients with multiple myeloma by optimizing care delivery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving patient outcomes through alternative care models, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris, Île-de-France
- Had — Paris, Île-de-France, France (Recruiting)
Study contacts
- Study coordinator: Bénédicte MITTAINE-MARZAC, PharmD
- Email: benedicte.mittaine-marzac@aphp.fr
- Phone: +33 1 42 34 84 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.