Clinical trial NCT04401046: COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
Official title: COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: COVID-19
POST TRAUMATIC STRESS
CANCER
ANXIETY
REORGANISATION OF CARE
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 1096
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Score of the Impact of Event Scale Revisited scale
timeFrame: at inclusion and 6 months later
Secondary outcomes:
measure: Factors associated with post-traumatic stress disorder
timeFrame: at inclusion and 6 months later
measure: Measure of the patient's anxiety
timeFrame: at inclusion and 6 months later
measure: proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.
timeFrame: at inclusion and 6 months later
measure: proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19
timeFrame: at inclusion and 6 months later
measure: proportion of patients stating that remote consultation is as useful as a face-to-face consultation
timeFrame: at inclusion and 6 months later
measure: proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)
timeFrame: at inclusion and 6 months later
measure: Score on the cancer recurrence scale
timeFrame: at inclusion and 6 months later
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Gwenaelle GRAVIS, MD
role: PRINCIPAL_INVESTIGATOR
References: