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

NCT ID: NCT03664856

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

interview

Intervention Type OTHER

The patient will be asked to answer the questions that the interviewer will ask him.

Interventions

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interview

The patient will be asked to answer the questions that the interviewer will ask him.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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EMILIE GARRIDO PRADALIE

Role: STUDY_DIRECTOR

APHM

Locations

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Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, France

Site Status

Countries

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France

Central Contacts

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SEBASTIEN SALAS, MD

Role: CONTACT

+33491384408

Facility Contacts

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SEBASTIEN SALAS, MD

Role: primary

References

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Salas S, Economos G, Hugues D, Gilbert E, Gracia D, Poulain P, Mateus C, Collet E, Planchet-Barraud B, Colpaert A, Perceau-Chambard E, Calvel LY, Franck C, Mallet D, Baumstarck K, Evin A. Legalisation of euthanasia and assisted suicide: advanced cancer patient opinions - cross-sectional multicentre study. BMJ Support Palliat Care. 2024 Jan 8;13(e3):e1335-e1341. doi: 10.1136/spcare-2022-004134.

Reference Type DERIVED
PMID: 37536753 (View on PubMed)

Other Identifiers

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2017-35

Identifier Type: -

Identifier Source: org_study_id

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