End Stage DiseaseEDAPALNCT04148924
Comparison Between the Assessment of Anxious and Depressive Symptomology
An observational study of End Stage Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In palliative care, anxiety and depression in advanced cancer are under evaluated, under diagnosed and therefore under treated. 5 to 30% of patients present anxious and depressive disorders. Physical symptoms are easy to assess. But in palliative care it is important to take care of moral suffering. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Disease
- What is being tested?
- Questionnaire and Medical staff questionnaire
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2019to 13 Nov 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients hospitalized in our palliative care unit
Who may be able to join
- Patients :
- Adult patients (18 years and over)
- Advanced cancer stage
- Patients hospitalized less than 72 hours in Lyon Sud palliative care unit
- Sufficient general conditions to complete survey
- Absence of cognitive disorders
Show all 9Show fewer
- Agreement to participate at the study
- Medical Staff:
- Working full time or part time in the USP or the PMSC of CHLS
Who cannot join
- Patients :
- Minor patients
- Patients hospitalized more than 72 hours in Lyon Sud palliative care unit
- Presence of cognitive disorders
- Alteration of general conditions
- Refusal to participate at the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Assessment of Anxious and Depressive Symptomology by the Patient and the Evaluation of the Patient's Symptoms by Caregivers: a Pilot Study Carried Out in a French Palliative Care Unit.
In palliative care, anxiety and depression in advanced cancer are under evaluated, under diagnosed and therefore under treated. 5 to 30% of patients present anxious and depressive disorders.
Physical symptoms are easy to assess. But in palliative care it is important to take care of moral suffering.
Read more
However, evaluation and management of patient's anxiety and depressive symptoms are difficult for physicians and caregivers.
The investigators would like to specifically compare the patient's evaluation of anxious and depressive symptomatology in palliative care with the evaluation by the physician, the nurse and the caregiver.
Then the investigators will try to collect the caregivers's difficulties in the management of anxious and depressive symptoms.
- Conditions
- End Stage Disease
- Being tested
- Questionnaire, Medical staff questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients complete a questionnaire for assess their symptoms like anxiety and depression.
These questionnaires contains:
- socio-demographic characteristics : sex, age, type and stage of cancer, performans status
- ESAS : Edmonton Symptom Assessement Scale is a validated tool for assessment of several symptoms
- HADS - A : Hospital Anxiety and Depression scale includes 2 subscales which assess anxiety (HADS-A) and depression (HADS-D)
- BEDS : Brief Edimburg depression Scale is s a relevant scale for assess depression in palliative care patients.
- Questions on the assessment, the treatment and difficulties in management of anxious and depressive symptoms.
The evaluation will be realized in the first days of hospitalization (72 hours).
Medical staff questionnaireOther
Questionnaire is different from caregivers. The evaluation will be realized in the first days of hospitalization (72 hours).
Physicians, nurses and caregivers complete another questionnaire. The physician questioned will be the doctor of unit having received the patient, or the doctor of the mobile team of palliative care having admitted the patient in the unit.
These questionnaires contains:
- socio-demographic characteristics : sex, age, type and stage of cancer, performans status
- ESAS : Edmonton Symptom Assessement Scale is a validated tool for assessment of several symptoms
| Study group | Role | What they receive |
|---|---|---|
| Patients | Anyone who is hospitalized in the palliative care service of the Lyon Sud Hospital Center. Receives: Other: Questionnaire | |
| Doctors | Doctors taking care of patients in the study will be solicited by the research nurse or a study investigator. Receives: Other: Medical staff questionnaire | |
| Nurses | Nurses taking care of patients in the study will be solicited by the research nurse or a study investigator. Receives: Other: Medical staff questionnaire | |
| Caregivers | Caregivers taking care of patients in the study will be solicited by the research nurse or a study investigator. Receives: Other: Medical staff questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the anxious and depressive symptomatology of hospitalized patients in palliative care unit (USP) evaluated on the one hand by the patient himself and on the other hand, in hetero evaluation, by caregivers.
The Edmonton Symptom Assessment Scale (ESAS) will be used for assess anxiety and depression intensity. The ESAS is a self-reported outcome tool assessing the intensity of nine symptoms (pain, tiredness, nausea, depressive mood, anxiety, drowsiness, lack of appetite, wellbeing, and breathlessness). Intensity is rated using 10-point Likert-scales from "no-symptom" (scored 0) to "worst possible symptom" (scored 10)
The difference of evaluation for anxiety and depressive symptoms is considere significant when there are two points and more between ESAS patient's and ESAS caregivers'.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start15 Nov 2019
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey FAWOUBO, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148924
- Sponsor's protocol ID
- 69HCL19_0301
- Acronym
- EDAPAL
- Status last verified
- Jul 2021
- First submitted
- 31 Oct 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Assessment of Anxious and Depressive Symptomology by the Patient and the Evaluation of the Patient's Symptoms by Caregivers: a Pilot Study Carried Out in a French Palliative Care Unit.
- ClinicalTrials.gov ID
- NCT04148924
- Acronym / sponsor ID
- EDAPAL / 69HCL19_0301
- Conditions
- End Stage Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 4 Nov 2019 (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.
In palliative care, anxiety and depression in advanced cancer are under evaluated, under diagnosed and therefore under treated. 5 to 30% of patients present anxious and depressive disorders.
Physical symptoms are easy to assess. But in palliative care it is important to take care of moral suffering.
However, evaluation and management of patient's anxiety and depressive symptoms are difficult for physicians and caregivers.
The investigators would like to specifically compare the patient's evaluation of anxious and depressive symptomatology in palliative care with the evaluation by the physician, the nurse and the caregiver.
Then the investigators will try to collect the caregivers's difficulties in the management of anxious and depressive symptoms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnaireAnyone who is hospitalized in the palliative care service of the Lyon Sud Hospital Center. |
| Doctors | – | Other: Medical staff questionnaireDoctors taking care of patients in the study will be solicited by the research nurse or a study investigator. |
| Nurses | – | Other: Medical staff questionnaireNurses taking care of patients in the study will be solicited by the research nurse or a study investigator. |
| Caregivers | – | Other: Medical staff questionnaireCaregivers taking care of patients in the study will be solicited by the research nurse or a study investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized in our palliative care unit
Key inclusion criteria (9 listed)
- Adult patients (18 years and over)
- Advanced cancer stage
- Patients hospitalized less than 72 hours in Lyon Sud palliative care unit
- Sufficient general conditions to complete survey
- Absence of cognitive disorders
Key exclusion criteria (6 listed)
- Minor patients
- Patients hospitalized more than 72 hours in Lyon Sud palliative care unit
- Presence of cognitive disorders
- Alteration of general conditions
- Refusal to participate at 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 |
|---|---|---|
| QuestionnairePatients complete a questionnaire for assess their symptoms like anxiety and depression. These questionnaires contains: * socio-demographic characteristics : sex, age, type and stage of cancer, performans status * ESAS : Edmonton Symptom Assessement Scale is a validated tool for assessment of several symptoms * HADS - A : Hospital Anxiety and Depression scale includes 2 subscales which assess anxiety (HADS-A) and depression (HADS-D) * BEDS : Brief Edimburg depression Scale is s a relevant scale for assess depression in palliative care patients. * Questions on the assessment, the treatment and difficulties in management of anxious and depressive symptoms. The evaluation will be realized in the first days of hospitalization (72 hours). | Other | Patients |
| Medical staff questionnaireQuestionnaire is different from caregivers. The evaluation will be realized in the first days of hospitalization (72 hours). Physicians, nurses and caregivers complete another questionnaire. The physician questioned will be the doctor of unit having received the patient, or the doctor of the mobile team of palliative care having admitted the patient in the unit. These questionnaires contains: * socio-demographic characteristics : sex, age, type and stage of cancer, performans status * ESAS : Edmonton Symptom Assessement Scale is a validated tool for assessment of several symptoms | Other | Caregivers, Doctors, Nurses |
Primary outcome
Comparison of the anxious and depressive symptomatology of hospitalized patients in palliative care unit (USP) evaluated on the one hand by the patient himself and on the other hand, in hetero evaluation, by caregivers.
Time frame: 72 hours
The Edmonton Symptom Assessment Scale (ESAS) will be used for assess anxiety and depression intensity. The ESAS is a self-reported outcome tool assessing the intensity of nine symptoms (pain, tiredness, nausea, depressive mood, anxiety, drowsiness, lack of appetite, wellbeing, and breathlessness). Intensity is rated using 10-point Likert-scales from "no-symptom" (scored 0) to "worst possible symptom" (scored 10) The difference of evaluation for anxiety and depressive symptoms is considere significant when there are two points and more between ESAS patient's and ESAS caregivers'.
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 2021.
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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.
Audrey FAWOUBO, MD principal investigator
Hospices Civils de Lyon
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 End Stage Disease, 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 9 inclusion and 6 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 2021. 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?
Comparison of the anxious and depressive symptomatology of hospitalized patients in palliative care unit (USP) evaluated on the one hand by the patient himself and on the other hand, in hetero evaluation, by caregivers. (time frame: 72 hours). 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 2021.