Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)
研究概览
简要总结
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer.
The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated.
详细描述
Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. Usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. Currently, this offer of care is rarely proposed, and only in particular situations. At the Hospital of Pau, it was introduced recently. It is proposed to patients who have been receiving immunotherapy for at least 4 months. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy. Given that there is neither regulatory obstacle nor any contraindication to care in home hospitalization, the choice of a descriptive study stands out.
This study will be proposed to all the patients for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting.
The patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and over.
- •with bronchial cancer treated with immunotherapy,
- •having two assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response)
- •without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy
- •eligible for a home-based hospitalization
排除标准
- •Patient receiving immunotherapy via temporary authorization for use,
- •Frail patients requiring a frequent medical assessment thus day hospitalization cares
结局指标
主要结局
Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)
时间窗: 1 year
Feasibility under good conditions of home-based immunotherapy, defined by the percentage of patients who interrupted their home hospitalization for reasons directly linked to that management.
次要结局
- adverse effects(1 year)
- Number of Incidents occurring during the Hospital at Home program handling process(1 year)
- Quality of Life Questionnaire (EORTC QLQ-C30) total score(at inclusion, month 3, 6 9 and 12)
- Patients' Satisfaction Questionnaire(1 year)
研究者
RENAULT Patrick Aldo
Principal Investigator
Centre Hospitalier de PAU