COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder (COVID-TRAUMA)
Primary Purpose
Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
Sponsored by
About this trial
This is an interventional health services research trial for Cancer focused on measuring COVID-19, POST TRAUMATIC STRESS, CANCER, ANXIETY, REORGANISATION OF CARE
Eligibility 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
Sites / Locations
- Institut Paoli-Calmettes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Post traumatic stress and anxiety evaluation
Arm Description
Outcomes
Primary Outcome Measures
Score of the Impact of Event Scale Revisited scale
Secondary Outcome Measures
Factors associated with post-traumatic stress disorder
The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale
Measure of the patient's anxiety
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.
proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19
proportion of patients stating that remote consultation is as useful as a face-to-face consultation
proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)
Score on the cancer recurrence scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04401046
Brief Title
COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
Acronym
COVID-TRAUMA
Official Title
COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
November 26, 2020 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
COVID-19, POST TRAUMATIC STRESS, CANCER, ANXIETY, REORGANISATION OF CARE
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1096 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post traumatic stress and anxiety evaluation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
Intervention Description
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 Measure Information:
Title
Score of the Impact of Event Scale Revisited scale
Time Frame
at inclusion and 6 months later
Secondary Outcome Measure Information:
Title
Factors associated with post-traumatic stress disorder
Description
The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale
Time Frame
at inclusion and 6 months later
Title
Measure of the patient's anxiety
Description
The measure of anxiety, measured by the State-Trait Anxiety Questionnaire
Time Frame
at inclusion and 6 months later
Title
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
Title
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
Title
proportion of patients stating that remote consultation is as useful as a face-to-face consultation
Time Frame
at inclusion and 6 months later
Title
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
Title
Score on the cancer recurrence scale
Time Frame
at inclusion and 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwenaelle GRAVIS, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
12. IPD Sharing Statement
Learn more about this trial
COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
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