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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
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Tracking Information
First Submitted Date  ICMJE May 22, 2020
First Posted Date  ICMJE May 26, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE May 20, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2020)
Score of the Impact of Event Scale Revisited scale [ Time Frame: at inclusion and 6 months later ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
Score of the IES-R (Impact of Event Scale Revisited) scale [ Time Frame: at inclusion and 6 months later ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 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 IES-R scale
  • Measure of the patient's anxiety [ Time Frame: at inclusion and 6 months later ]
    The measure of anxiety, measured by the Stait-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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
Official Title  ICMJE COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Cancer
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Post traumatic stress and anxiety evaluation
Intervention: Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2020)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique Genre, MD +33491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD, PhD +33491223778
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04401046
Other Study ID Numbers  ICMJE COVID-TRAUMA-IPC 2020-026
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gwenaelle GRAVIS, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP