Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 483
- 试验地点
- 1
- 主要终点
- Emergent Serious Adverse Events
研究概览
简要总结
Observational two year study to evaluate the utility of a decision-support sheet on how to proceed in case of aggravation of a patient's condition with advanced disease.
详细描述
Prospective and multicenter study conducted in the Rhône-Alpes-Auvergne area. All patients suffering from lung cancer admitted to a pulmonology unit in 2014 will be included. This document will be used if a decision to withhold life-sustaining treatment is decided. Investigators will assess the relationship between the planned intensity of care and those established when the patient develops an organ failure. Patient characteristics and factors associated with proposed levels and types of care will be analyzed. Patient and family opinions will be obtained after 3 months. The number of subjects is 468.
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
- •Any patient with lung cancer, hospitalized in pulmonology unit in one of the participating centers.
- •Patient who requires a decision to withhold life-sustaining treatment
- •One patient can be included at each hospitalization.
排除标准
- •Minor patient
- •Refusal of participation of the patient in the study
结局指标
主要结局
Emergent Serious Adverse Events
时间窗: 1 year and a half
The main objective of this study is to assess the relationship between the planned intensity of care and those established when the patient develops organ failure. The agreement will be assessed using Cohen's kappa coefficient .
次要结局
- Patient feeling assessment using phone interview questionnaire(3 months after patient inclusion)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(first day)