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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04401046
Acronym
COVID-TRAUMA
Enrollment
1096
Registered
2020-05-26
Start date
2020-05-20
Completion date
2021-02-02
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

COVID-19, POST TRAUMATIC STRESS, CANCER, ANXIETY, REORGANISATION OF CARE

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.

Interventions

OTHERSurvey 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).

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Score of the Impact of Event Scale Revisited scaleat inclusion and 6 months later

Secondary

MeasureTime frameDescription
Measure of the patient's anxietyat inclusion and 6 months laterThe 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.at inclusion and 6 months later
proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19at inclusion and 6 months later
Factors associated with post-traumatic stress disorderat inclusion and 6 months laterThe factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale
proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)at inclusion and 6 months later
Score on the cancer recurrence scaleat inclusion and 6 months later
proportion of patients stating that remote consultation is as useful as a face-to-face consultationat inclusion and 6 months later

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026