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

Institut Paoli-Calmettes

Status: Completed

Conditions: Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04401046

COVID-TRAUMA-IPC 2020-026

Details and patient eligibility

About

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.

Enrollment: 1,096 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,096 participants in 1 patient group

Post traumatic stress and anxiety evaluation

Experimental group

Treatment:

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