Comparison Between the Assessment of Anxious and Depressive Symptomology

NCT04148924 | Completed

• 1 other identifier: 69HCL19_0301
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Patients

Anyone who is hospitalized in the palliative care service of the Lyon Sud Hospital Center.

Other: Questionnaire

Doctors

Doctors taking care of patients in the study will be solicited by the research nurse or a study investigator.

Other: Medical staff questionnaire

Nurses

Nurses taking care of patients in the study will be solicited by the research nurse or a study investigator.

Other: Medical staff questionnaire

Caregivers

Caregivers taking care of patients in the study will be solicited by the research nurse or a study investigator.

Other: Medical staff questionnaire

Interventions

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).

Patients

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

Caregivers; Doctors; Nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients hospitalized in our palliative care unit

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Audrey FAWOUBO, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: November 15, 2019
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

FR (1)