跳至主要内容
临床试验/NCT03664856
NCT03664856Unknown不适用

The Opinion of Patients With Cancer on the Claeys-Leonetti Law, on Euthanasia and the Search for Determining Factors

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,000
试验地点
2
主要终点
EORTC QLQ-C15-PAL scale

研究概览

简要总结

The law of February 2nd 2016, known as Claeys-Leonetti, reformed the legislation of the end of life. It establishes in particular a right of the patient to deep and continuous sedation, makes advance directives binding but refuses access to euthanasia. It states that artificial hydration and nutrition are treatments and not cares, which means that they can be stopped once they are deemed unnecessary, disproportionate or have no other effect than artificial maintenance of life.

While a number of personalities from all walks of life were heard during the parliamentary debate, it was found that patients were not asked about main issues under discussion. Therefore, the investigators found it useful to collect their opinions in the context of individual interviews.

A feasibility study was carried out among 40 patients, which demonstrated the feasibility of such project. This study is the subject of an article which is currently submitted to the BMC Palliative Care Journal.

The main objective is to contribute to the elaboration of the legislation on the end of life, to its adaptation to the wishes of the patients. Patients with cancer and palliative care are directly affected by the legislation on end-of-life, and it seems legitimate that these legislative provisions correspond to their expectations. The aims also to help caregivers to act in accordance with their wishes.

详细描述

The law of February 2nd 2016, known as Claeys-Leonetti, reformed the legislation of the end of life. It establishes in particular a right of the patient to deep and continuous sedation, makes advance directives binding but refuses access to euthanasia. It also states that artificial hydration and nutrition are treatments and not cares, which means that they can be stopped once they are deemed unnecessary, disproportionate or have no other effect than artificial maintenance of life.

While a number of personalities from all walks of life were heard during the parliamentary debate, it was found that patients were not asked about main issues under discussion. Therefore, the investigators found it useful to collect their opinions in the context of individual interviews.

A feasibility study was carried out among 40 patients, which demonstrated the feasibility of such project. This study is the subject of an article which is currently submitted to the BMC Palliative Care Journal.

The main objective is to contribute to the elaboration of the legislation on the end of life, to its adaptation to the wishes of the patients. Patients with cancer and palliative care are directly affected by the legislation on end-of-life, and it seems legitimate that these legislative provisions correspond to their expectations. The aims also to help caregivers to act in accordance with their wishes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Subject suffering from a locally advanced or metastatic cancer therefore falling under palliative care according to the definition stated by the according to the definition stated by the French Society of Support and Palliative Care
  • Subject inpatient palliative care unit or identified palliative care beds or followed by a mobile palliative care team or home-based subject followed by a palliative care network or a mobile palliative care team out-of-hospital
  • Subject not opposed to taking part in the study;

排除标准

  • Subject unable to understand the purpose and conditions of the study

研究组 & 干预措施

experimental group

Experimental

Subject suffering from a locally advanced or metastatic cancer therefore falling under palliative care as defined by the definition of the French Society of Support and Palliative Care An interview will be performed

干预措施: interview (Other)

结局指标

主要结局

EORTC QLQ-C15-PAL scale

时间窗: 30 minutes

The European Organization for Research and Treatment of Cancer (EORTC) questionnaire of life quality (QLQ) is a questionnaire developed to assess the quality of life of palliative (PAL) cancer care patients. It is a self-questionnaire, to determine the quality of life of the patient. It contains 14 items from 1 to 4. A 15th item, from 1 to 7, gives an overall score corresponding to the quality of life that the patient feels he has. From a minimal score (15) representing the worst quality of life until the maximal score (63) representing the best quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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