Palliative CareANTICIPALLNCT05662917
Advance Care Planning in Palliative Care
An observational study of Palliative Care, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The question of the end of life is a major public health issue. In the field of palliative care, the notion of anticipation is central for people with a serious and progressive illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Individual semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2023to 10 Dec 2023
- Phase
- Observational
- 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
Study population: The study population concerns patients in palliative situation, either hospitalized in palliative care unit or followed at home by the Mobile Palliative Care Team. The number of subjects required is estimated at a minimum of 15 participants (depend on data saturation)
Who may be able to join
- Persons of all genders
- Persons 18 years of age and older
- In a palliative care situation of any serious illness
- Persons hospitalized in palliative care unit at the Givors hospital or followed at home by the Mobile Palliative Care Team
- Patients who have received full information about the study and signed a written consent.
Who cannot join
- Persons under legal protection
- Persons unable to express their consent, making it impossible to conduct interviews: dysarthria, cognitive disorders, mental confusion, altered state of consciousness
- Pregnant or breastfeeding persons
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Givors Hospital Center - Multidisciplinary medicine and palliative care department
Givors, 69700
Manon JULLIAN, 4 78 07 30 91 ext. +33, mjullian@ch-givors.fr
Julien TRAUTMANN, MD, 4 78 07 31 38 ext. +33, jtrautmann@ch-givors.fr
About this study
Official title: What Are the Views of Palliative Care Patients Regarding the Use of Anticipatory Prescribing ?
The question of the end of life is a major public health issue. In the field of palliative care, the notion of anticipation is central for people with a serious and progressive illness. Indeed, an important consideration for general practitioners is the need to anticipate the disease's evolution and the uncomfortable symptoms (physical or psychological) the patient is likely to experience. This approach aims to relieve the patient without delay and thus improve comfort to ensure an acceptable quality of life for patients and their families. Even if the usefulness of anticipatory prescribing seems obvious, their use is not generalized to all palliative care patients. Caregivers are confronted with obstacles to the implementation of these prescriptions, particularly with regard to the relationship with the patient. It can then be assumed that patients' experiences and perceptions may influence symptom management and the use of anticipatory prescriptions. It seems essential to explore this subject. For this purpose, the investigator will carry out a qualitative study based on individual semi-structured interviews with palliative care patients.
- Conditions
- Palliative Care
- Being tested
- Individual semi-structured interviews
- Keywords
- Palliative care, Advance care planning, Anticipatory prescribing, End of life, Patient experiences
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual semi-structured interviewsBehavioural
After information and written consent, the investigator will interview the participants through a semi-structured individual interview (conducted by an interview guide). The interview is expected to last 45 minutes (variable depending on the subject). It will be recorded by dictaphone, respecting the anonymity of the participant throughout the interview. The subject's participation will end after the interview.
| Study group | Role | What they receive |
|---|---|---|
| Palliative care patients | * Palliative care patients
* Suffering from a serious and progressive illness (whatever it is)
* Hospitalized in a palliative care unit or followed at home by the hospital's mobile palliative care team Receives: Behavioral: Individual semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is patient views on the use of anticipatory prescribing.
The interview consists in exploring the participants' experiences (feelings, representations), expectations and difficulties concerning the use of anticipatory prescribing. Interviews will be audio recorded. The verbatim will be transcribed for qualitative analysis by inductive thematic type, in order to bring out the main ideas and hypotheses.
Measured: The outcome will be collected at Day 1-End of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start10 Mar 2023
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
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.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon JULLIAN, Principal investigator, Multidisciplinary medicine and palliative care department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662917
- Sponsor's protocol ID
- 69HCL22_0747
- Other IDs
- ID-RCB
- Acronym
- ANTICIPALL
- Status last verified
- Aug 2023
- First submitted
- 12 Dec 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Views of Palliative Care Patients Regarding the Use of Anticipatory Prescribing ?
- ClinicalTrials.gov ID
- NCT05662917
- Acronym / sponsor ID
- ANTICIPALL / 69HCL22_0747
- Conditions
- Palliative Care
- Keywords
- Palliative care, Advance care planning, Anticipatory prescribing, End of life, Patient experiences
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 23 Dec 2022 (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 question of the end of life is a major public health issue. In the field of palliative care, the notion of anticipation is central for people with a serious and progressive illness. Indeed, an important consideration for general practitioners is the need to anticipate the disease's evolution and the uncomfortable symptoms (physical or psychological) the patient is likely to experience. This approach aims to relieve the patient without delay and thus improve comfort to ensure an acceptable quality of life for patients and their families. Even if the usefulness of anticipatory prescribing seems obvious, their use is not generalized to all palliative care patients. Caregivers are confronted with obstacles to the implementation of these prescriptions, particularly with regard to the relationship with the patient. It can then be assumed that patients' experiences and perceptions may influence symptom management and the use of anticipatory prescriptions. It seems essential to explore this subject. For this purpose, the investigator will carry out a qualitative study based on individual semi-structured interviews with palliative care patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative care patients | – | Behavioral: Individual semi-structured interviews* Palliative care patients * Suffering from a serious and progressive illness (whatever it is) * Hospitalized in a palliative care unit or followed at home by the hospital's mobile palliative care team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population concerns patients in palliative situation, either hospitalized in palliative care unit or followed at home by the Mobile Palliative Care Team. The number of subjects required is estimated at a minimum of 15 participants (depend on data saturation)
Key inclusion criteria (5 listed)
- Persons of all genders
- Persons 18 years of age and older
- In a palliative care situation of any serious illness
- Persons hospitalized in palliative care unit at the Givors hospital or followed at home by the Mobile Palliative Care Team
- Patients who have received full information about the study and signed a written consent.
Key exclusion criteria (3 listed)
- Persons under legal protection
- Persons unable to express their consent, making it impossible to conduct interviews: dysarthria, cognitive disorders, mental confusion, altered state of consciousness
- Pregnant or breastfeeding persons
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 |
|---|---|---|
| Individual semi-structured interviewsAfter information and written consent, the investigator will interview the participants through a semi-structured individual interview (conducted by an interview guide). The interview is expected to last 45 minutes (variable depending on the subject). It will be recorded by dictaphone, respecting the anonymity of the participant throughout the interview. The subject's participation will end after the interview. | Behavioural | Palliative care patients |
Primary outcome
The primary outcome is patient views on the use of anticipatory prescribing.
Time frame: The outcome will be collected at Day 1-End of study visit
The interview consists in exploring the participants' experiences (feelings, representations), expectations and difficulties concerning the use of anticipatory prescribing. Interviews will be audio recorded. The verbatim will be transcribed for qualitative analysis by inductive thematic type, in order to bring out the main ideas and hypotheses.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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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.
Manon JULLIAN principal investigator
Multidisciplinary medicine and palliative care department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care, run by Hospices Civils de Lyon 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 5 inclusion and 3 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 8 Aug 2023. 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 Manon JULLIAN (4 78 07 30 91 ext. +33, manonjullian@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is patient views on the use of anticipatory prescribing. (time frame: The outcome will be collected at Day 1-End of study visit). 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 8 Aug 2023.