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

Cancer Clinical Trial

— EPAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03664856
• Other study ID #: 2017-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: SEBASTIEN SALAS, MD
• Phone: +33491384408
• Email: Sebastien.SALAS[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• interview
The patient will be asked to answer the questions that the interviewer will ask him.

Locations

Country	Name	City	State
France	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ-C15-PAL scale	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.	30 minutes