Benefits of Early Collaboration Between Oncologists and Palliative Care Physicians in Cases of Unplanned Hospitalization for Patients With Metastatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 493
- 试验地点
- 1
- 主要终点
- Aggressiveness of end-of-life care (composite endpoint)
研究概览
简要总结
This is a multicenter, national, interventional, cluster-randomized study, "stepped wedge" design. This study includes patients with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer, currently undergoing systemic palliative treatment and hospitalized on an unscheduled basis. The study will aim to evaluate the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization.
详细描述
This study will aim to evaluate the effectiveness of early palliative care for patients with metastatic or advanced cancer identified through unscheduled hospitalization in terms of reducing "aggressive" treatment.
Other objectives of the study include :
Compare approaches in terms of overall survival, treatment toxicities, advance directives, quality of life, anxiety, and depression.
- Describing care according to the organization at the time of inclusion.
- Evaluating the economic impact of early palliative care in patients with metastatic or advanced cancer through a medico-economic analysis combining cost-effectiveness and cost-utility analysis.
- Evaluating interactions between the various stakeholders (palliative care physicians, supportive care physicians, oncologists).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Subjects aged 18 years and older;
- •Diagnosed with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer;
- •Currently undergoing systemic palliative treatment (no prospect of cure);
- •Hospitalized on an unscheduled basis (i.e., unplanned hospitalization for scheduled oncology treatments);
- •Patient covered by the French social security system;
- •Informed consent, written and signed.
排除标准
- •PS (WHO) = 4;
- •Patient receiving end-of-life care;
- •Patient opposed to the use of medical data for research purposes;
- •Person deprived of liberty or under guardianship;
- •Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.
结局指标
主要结局
Aggressiveness of end-of-life care (composite endpoint)
时间窗: Assessed during the last 30 days of life and up to 14 days before death
Treatment will be considered aggressive if at least one of the following criteria is met (composite criterion): * Administration of systemic IV treatment (chemotherapy, targeted therapy, immunotherapy) within 14 days prior to death * At least one visit to the emergency room within 30 days prior to death * At least one admission to intensive care within 30 days prior to death * At least one admission to resuscitation within 30 days prior to death * Death in hospital outside of palliative care
次要结局
- Components and additional indicators of aggressiveness of end-of-life care(Assessed during the last 30 days of life and up to 14 days before death)
- Overall survival(From study inclusion until death from any cause (follow-up up to 12 months))
- Quality of life(Baseline and every 3 months until death or up to 12 months)
- Psychological distress and care pathway indicators(Baseline and every 3 months until death or up to 12 months)
- Time Until Definitive Deterioration(Baseline and every 3 months until death or up to 12 months)