COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder (COVID-TRAUMA)

COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder

The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence.

It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later.

Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later

• Study Type: Interventional
• Enrollment (Actual): 1096
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13273
    • Institut Paoli-Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Man or woman, age>18
• Diagnosis of cancer (solid tumor or hematology)
• Out patient or patient Under surveillance

Exclusion Criteria:

• Refusal to participate in the study
• Emergency, person deprived of liberty
• hospitalized patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Post traumatic stress and anxiety evaluation

Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later; The first survey will include questions relative to sociodemographic characteristics, existence of psychological troubles; living conditions in the Covid19 pandemic context; IES-R, Stait Trait Anxiety, and the fear of a cancer recurrence scales, satisfaction with cancer care and medical status of patients (diagnosis, ongoing treatment, follow-up of the disease).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score of the Impact of Event Scale Revisited scale	at inclusion and 6 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with post-traumatic stress disorder	The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale	at inclusion and 6 months later
Measure of the patient's anxiety	The measure of anxiety, measured by the State-Trait Anxiety Questionnaire	at inclusion and 6 months later
proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.		at inclusion and 6 months later
proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19		at inclusion and 6 months later
proportion of patients stating that remote consultation is as useful as a face-to-face consultation		at inclusion and 6 months later
proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)		at inclusion and 6 months later
Score on the cancer recurrence scale		at inclusion and 6 months later

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2020
• Primary Completion (ACTUAL): November 26, 2020
• Study Completion (ACTUAL): February 2, 2021

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (ACTUAL): May 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; CANCER; ANXIETY; POST TRAUMATIC STRESS; REORGANISATION OF CARE
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; COVID-19; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: COVID-TRAUMA-IPC 2020-026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No