Comparison Between the Assessment of Anxious and Depressive Symptomology

End Stage Disease Clinical Trial

— EDAPAL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148924
• Other study ID #: 69HCL19_0301
• Status: Completed
• Start date: November 15, 2019
• Est. completion date: November 13, 2020

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 13, 2020
• Est. primary completion date: November 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Disease

Intervention

Other:
• Questionnaire
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
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

Locations

Country	Name	City	State
France	Hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'.	72 hours