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Comparison Between the Assessment of Anxious and Depressive Symptomology

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04148924
Acronym
EDAPAL
Enrollment
100
Registered
2019-11-04
Start date
2019-11-15
Completion date
2020-11-13
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Disease

Brief 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. 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.

Interventions

OTHERQuestionnaire

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).

OTHERMedical staff questionnaire

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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 * Agreement to participate at the study Medical Staff: \- Working full time or part time in the USP or the PMSC of CHLS

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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.72 hoursThe 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'.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026