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NCT Number: NCT04401046

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

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.

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Key information

Conditions

Cancer Anxiety Disorders COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli-Calmettes

Marseille, 13273, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Score of the Impact of Event Scale Revisited scale

    Time frame: at inclusion and 6 months later

Secondary outcomes

  1. Factors associated with post-traumatic stress disorder

    Time frame: at inclusion and 6 months later

    The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale

  2. Measure of the patient's anxiety

    Time frame: at inclusion and 6 months later

    The measure of anxiety, measured by the State-Trait Anxiety Questionnaire

  3. proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.

    Time frame: at inclusion and 6 months later

  4. proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19

    Time frame: at inclusion and 6 months later

  5. proportion of patients stating that remote consultation is as useful as a face-to-face consultation

    Time frame: at inclusion and 6 months later

  6. proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)

    Time frame: at inclusion and 6 months later

  7. Score on the cancer recurrence scale

    Time frame: at inclusion and 6 months later

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: COVID-TRAUMA

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 26, 2020
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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