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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later

• Registration Number: NCT04401046
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Primary Completion: 2020-11-26
• Study Completion: 2021-02-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1096

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post traumatic stress and anxiety evaluation	Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later	-

Primary Outcome Measures

Name	Time	Method
Score of the Impact of Event Scale Revisited scale	at inclusion and 6 months later

Secondary Outcome Measures

Name	Time	Method
Score on the cancer recurrence scale	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 with access to a clinical psychology consultation (at the hospital or on the phone)	at inclusion and 6 months later
Factors associated with post-traumatic stress disorder	at inclusion and 6 months later	The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale
Measure of the patient's anxiety	at inclusion and 6 months later	The measure of anxiety, measured by the State-Trait Anxiety Questionnaire
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 stating that remote consultation is as useful as a face-to-face consultation	at inclusion and 6 months later

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France