Palliative CareDESANCT02845817
Requests for Euthanasia and Assisted Suicide
A study testing Qualitative research in people with Palliative Care and End of Life, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study take place in the palliative care units of Burgundy-Franche-Comté regions and at the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, End of Life, Euthanasia
- What is being tested?
- Qualitative research
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Jun 2015
- 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
- Adult not under guardianship or curatorship,
- Hospitalized in palliative care units of Bourgogne-Franche-Comté region and in the Maison Médicale Jeanne Garnier in Paris,
- At the end of life due to advanced stage disease or a major change in the state of health of an elderly person,
- They have made an explicit request for euthanasia or assisted suicide,
- They are in capacity to meet researchers for interview,
- Having consented to interviews,
- They are covered by the French social security system.
Who cannot join
- Adult under guardianship or curatorship,
- They are underage,
- They are not hospitalized in Palliative Care Unit of Bourgogne-Franche-Comté region and in the Maison Médicale Jeanne Garnier,
- The request was expressed by another person or not explicit,
- They didn't consent to interviews,
- The request appears in the context of a situation other than illness or a general change in state of health
- They are not in capacity to meet researchers for interviews.
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU Besançon - Palliative Care Unit
Besançon, Bourgogne-Franche-Comté, 25000
About this study
Official title: Requests for Euthanasia and Assisted Suicide: a Prospective, Multicenter and Qualitative Study of Their Frequency and Characteristics, of Patients' Motivations and Their Evolution
This study take place in the palliative care units of Burgundy-Franche-Comté regions and at the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide).
This involves conducting interviews with patients, carers to whom the request has been expressed and a relative chosen by the patient. This study aims to describe the request over time. This will be done through two series of interviews, one as soon as it is first expressed, then one week later.
- Conditions
- Palliative Care, End of Life, Euthanasia, Assisted Suicide, Qualitative Research
- Being tested
- Qualitative research
- Medical subject headings
- Death, Suicide, Assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative researchOther
Semi-structured interviews
| Study group | Role | What they receive |
|---|---|---|
| Qualitative research | Other | Semi-structured interviews Receives: Other: Qualitative research |
What is being measured
The primary outcome is the main question the study is designed to answer.
70 semi-structured interviews
Qualitative data analysis - Theoretical concept saturation and thematic analyses. [analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide)]
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Maison Médicale Jeanne Garnier
- Responsible party
- Sponsor
- Investigators
- Régis AUBRY, PR, Principal investigator, Centre Hospitalier Universitaire de BesanconDanièle LEBOUL, MCU, Principal investigator, Maison Médicale Jeanne GarnierFrédéric GUIRIMAND, DR, Principal investigator, Maison Médicale Jeanne GarnierAline CHASSAGNE, IRC, Principal investigator, Centre Hospitalier Universitaire de BesanconFlorence MATHIEU-NICOT, Phd, Principal investigator, Centre Hospitalier Universitaire de BesanconAnne BOUSQUET, Phd, Principal investigator, Maison Médicale Jeanne Garnier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845817
- Sponsor's protocol ID
- DESA
- Acronym
- DESA
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Requests for Euthanasia and Assisted Suicide: a Prospective, Multicenter and Qualitative Study of Their Frequency and Characteristics, of Patients' Motivations and Their Evolution
- ClinicalTrials.gov ID
- NCT02845817
- Acronym / sponsor ID
- DESA / DESA
- Conditions
- Palliative Care, End of Life, Euthanasia, Assisted Suicide, Qualitative Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Maison Médicale Jeanne Garnier
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
This study take place in the palliative care units of Burgundy-Franche-Comté regions and at the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide).
This involves conducting interviews with patients, carers to whom the request has been expressed and a relative chosen by the patient. This study aims to describe the request over time. This will be done through two series of interviews, one as soon as it is first expressed, then one week later.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative research | Other | Other: Qualitative researchSemi-structured interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult not under guardianship or curatorship,
- Hospitalized in palliative care units of Bourgogne-Franche-Comté region and in the Maison Médicale Jeanne Garnier in Paris,
- At the end of life due to advanced stage disease or a major change in the state of health of an elderly person,
- They have made an explicit request for euthanasia or assisted suicide,
- They are in capacity to meet researchers for interview,
Key exclusion criteria (7 listed)
- Adult under guardianship or curatorship,
- They are underage,
- They are not hospitalized in Palliative Care Unit of Bourgogne-Franche-Comté region and in the Maison Médicale Jeanne Garnier,
- The request was expressed by another person or not explicit,
- They didn't consent to interviews,
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 |
|---|---|---|
| Qualitative researchSemi-structured interviews | Other | Qualitative research |
Primary outcome
70 semi-structured interviews
Time frame: 12 months
Qualitative data analysis - Theoretical concept saturation and thematic analyses. [analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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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.
Régis AUBRY, PR principal investigator
Centre Hospitalier Universitaire de Besancon
Danièle LEBOUL, MCU principal investigator
Maison Médicale Jeanne Garnier
Frédéric GUIRIMAND, DR principal investigator
Maison Médicale Jeanne Garnier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative research in people with Palliative Care and End of Life, run by Centre Hospitalier Universitaire de Besancon 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
70 semi-structured interviews (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2016.