Completed

NCT Number: NCT04148924

Comparison Between the Assessment of Anxious and Depressive Symptomology

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.

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Key information

Conditions

End Stage Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Lyon Sud

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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 questionnaire

Other

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

Primary outcomes

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'.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: EDAPAL

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 4, 2019
Registry last updated: Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed