Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Quality of life using questionnaires EORTC QLQ-30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Quality of life using questionnaires EORTC QLQ-30
时间窗: At baseline, at the 6th month and the 12th month
Comparison of quality of life using questionnaires EORTC QLQ-30.
Change in Quality of life using questionnaires EORTC QLQ-MY20
时间窗: At baseline, at the 6th month and the 12th month
Comparison of quality of life using questionnaires EORTC QLQ-MY20.
次要结局
- 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)
- Survival(At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days))
- Total Cost(At the end of study: 3 years)
- Fate-to-face interview with patients, caregivers and healthcare staff(At baseline, at the 6th month and the 12th month)