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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401046
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cancer Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Score of the Impact of Event Scale Revisited scale [ Time Frame: at inclusion and 6 months later ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Dominique Genre, MD +33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD, PhD +33491223778

Locations
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France
Institut Paoli-Calmettes Recruiting
Marseille, France, 13273
Contact: Gwénaëlle GRAVIS, MD    33 (0)4 91 22 37 78    drci.up@ipc.unicancer.fr   
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Gwenaelle GRAVIS, MD Institut Paoli-Calmettes
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT04401046    
Other Study ID Numbers: COVID-TRAUMA-IPC 2020-026
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
COVID-19
POST TRAUMATIC STRESS
CANCER
ANXIETY
REORGANISATION OF CARE
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders