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

Sponsor
Institut Paoli-Calmettes (Other)
Overall Status
Completed
CT.gov ID
NCT04401046
Collaborator
(none)
1,096
Enrollment
1
Location
1
Arm
8.5
Actual Duration (Months)
129.3
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1096 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
Actual Primary Completion Date :
Nov 26, 2020
Actual Study Completion Date :
Feb 2, 2021

Arms and Interventions

ArmIntervention/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).

Outcome Measures

Primary Outcome Measures

  1. Score of the Impact of Event Scale Revisited scale [at inclusion and 6 months later]

Secondary Outcome Measures

  1. Factors associated with post-traumatic stress disorder [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 [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. [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 [at inclusion and 6 months later]

  5. proportion of patients stating that remote consultation is as useful as a face-to-face consultation [at inclusion and 6 months later]

  6. proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone) [at inclusion and 6 months later]

  7. Score on the cancer recurrence scale [at inclusion and 6 months later]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Institut Paoli-CalmettesMarseilleFrance13273

Sponsors and Collaborators

  • Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Gwenaelle GRAVIS, MD, Institut Paoli-Calmettes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT04401046
Other Study ID Numbers:
  • COVID-TRAUMA-IPC 2020-026
First Posted:
May 26, 2020
Last Update Posted:
Jul 22, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Paoli-Calmettes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2021