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

NCT04401046 | Completed

• 1 other identifier: COVID-TRAUMA-IPC 2020-026
• Study Type: interventional
• Target: 1,096
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

COVID-19; POST TRAUMATIC STRESS; CANCER; ANXIETY; REORGANISATION OF CARE

Outcome Measures

Primary Outcomes (1)

• Score of the Impact of Event Scale Revisited scale

  at inclusion and 6 months later

Secondary Outcomes (7)

• Factors associated with post-traumatic stress disorder

  at inclusion and 6 months later

• Measure of the patient's anxiety

  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

Study Arms (1)

Post traumatic stress and anxiety evaluation

EXPERIMENTAL

Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later

Interventions

Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later OTHER

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).

Post traumatic stress and anxiety evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13273, France

Location

MeSH Terms

Conditions

Neoplasms; COVID-19; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Study Officials

• Gwenaelle GRAVIS, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: May 20, 2020
• Primary Completion: November 26, 2020
• Study Completion: February 2, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

FR (1)