COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder (COVID-TRAUMA)
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|ClinicalTrials.gov Identifier: NCT04401046|
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : July 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder|
|Actual Study Start Date :||May 20, 2020|
|Estimated Primary Completion Date :||October 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
|Experimental: Post traumatic stress and anxiety evaluation||
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).
- Score of the Impact of Event Scale Revisited scale [ Time Frame: at inclusion and 6 months later ]
- 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
- 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
- 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 ]
- 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 ]
- proportion of patients stating that remote consultation is as useful as a face-to-face consultation [ Time Frame: at inclusion and 6 months later ]
- 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 ]
- Score on the cancer recurrence scale [ Time Frame: at inclusion and 6 months later ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401046
|Contact: Dominique Genre, MDemail@example.com|
|Contact: Jihane PAKRADOUNI, PharmD, PhD||+33491223778|
|Marseille, France, 13273|
|Contact: Gwénaëlle GRAVIS, MD 33 (0)4 91 22 37 78 firstname.lastname@example.org|
|Principal Investigator:||Gwenaelle GRAVIS, MD||Institut Paoli-Calmettes|