CancerEPALNCT03664856
The Opinion of Patients With Cancer on the Claeys-Leonetti Law, on Euthanasia and Determining Factors
A study testing interview in people with Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Subject unable to understand the purpose and conditions of the study
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
SEBASTIEN SALAS, MD, Sebastien.SALAS@ap-hm.fr, Sebastien.SALAS@ap-hm.fr
About this study
Official title: The Opinion of Patients With Cancer on the Claeys-Leonetti Law, on Euthanasia and the Search for Determining Factors
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.
Read more
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.
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- interview
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
The patient will be asked to answer the questions that the interviewer will ask him.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664856
- Sponsor's protocol ID
- 2017-35
- Acronym
- EPAL
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evin A, 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, Salas S. Advanced cancer patients' knowledge and opinions regarding the French law on advance directives: a multicenter cross-sectional study. Support Care Cancer. 2026 Jan 20;34(2):109. doi: 10.1007/s00520-026-10352-3.
PubMed 41554986Salas 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.
PubMed 37536753
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Opinion of Patients With Cancer on the Claeys-Leonetti Law, on Euthanasia and the Search for Determining Factors
- ClinicalTrials.gov ID
- NCT03664856
- Acronym / sponsor ID
- EPAL / 2017-35
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: interviewSubject 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (1 listed)
- Subject unable to understand the purpose and conditions of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewThe patient will be asked to answer the questions that the interviewer will ask him. | Other | experimental group |
Primary outcome
EORTC QLQ-C15-PAL scale
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 41554986Evin A, 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, Salas S. Advanced cancer patients' knowledge and opinions regarding the French law on advance directives: a multicenter cross-sectional study. Support Care Cancer. 2026 Jan 20;34(2):109. doi: 10.1007/s00520-026-10352-3.
- Derived from this study: PubMed 37536753Salas 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.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interview in people with Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEBASTIEN SALAS, MD (+33491384408, Sebastien.SALAS@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-C15-PAL scale (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664856, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.