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

Cancer Clinical Trial

— COVID-TRAUMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401046
• Other study ID #: COVID-TRAUMA-IPC 2020-026
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: July 2021
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1096
• Est. completion date: February 2, 2021
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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).

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the Impact of Event Scale Revisited scale		at inclusion and 6 months later
Secondary	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
Secondary	Measure of the patient's anxiety	The measure of anxiety, measured by the State-Trait Anxiety Questionnaire	at inclusion and 6 months later
Secondary	proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.		at inclusion and 6 months later
Secondary	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
Secondary	proportion of patients stating that remote consultation is as useful as a face-to-face consultation		at inclusion and 6 months later
Secondary	proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)		at inclusion and 6 months later
Secondary	Score on the cancer recurrence scale		at inclusion and 6 months later