Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19

In the context of the COVID-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (PTSD). PTSD generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... The current health crisis also represents an increased risk of PTSD.

After the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... In some people, PTSD can lead to more disabling problems such as (crowd) avoidance.

In order to help patients with PTSD, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference.

A previous study conducted at the François Baclesse Center during the first COVID-19 lockdown (April to June 2020), which included 735 patients, assessed the impact of the pandemic on cancer patients treated in day hospitals. That study found that 21% of patients met criteria for post-traumatic stress disorder (PTSD) and 23% reported insomnia. Based on these findings, the present study was designed to evaluate the effectiveness of an adapted psychological intervention for patients with pandemic-related PTSD.

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Key information

Conditions

Solid Carcinoma COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral Post Traumatic Stress Disorder RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Francois Baclesse

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient ≥ 18 years old
Patient treated or followed up for a solid tumour at the François Baclesse Centre
Patient with a score suggesting moderate or high posttraumatic stress symptoms (IES-R score ≥ 24) related to the COVID-19 epidemic
The patient's state of health is compatible with the programme: psychological care for 6 months.
Information note signed by the patient
Any associated geographical, social or psychopathological conditions that might compromise the patient's ability to participate in the study

Exclusion criteria

Patient with no symptoms suggestive of moderate or high post-traumatic stress (IES-R score <24)
Patient deprived of liberty or under guardianship
Patient already receiving psychological care
Patient whose diagnosis of the disease was made within one month prior to the proposal for participation

Treatment and study plan

Psychological Support

Other

Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.

Primary outcomes

Proportion of Patients With Improvement in Post-traumatic Stress Symptoms

Time frame: 6 months

Improvement in post-traumatic stress symptoms observed during or at the end of the intervention, defined as a decrease below the threshold of 24 on the Impact of Event Scale-Revised (IES-R) compared with baseline.

The Impact of Event Scale-Revised (IES-R) is a 22-item self-report questionnaire assessing post-traumatic stress symptoms across intrusion, avoidance, and hyperarousal domains, with total scores ranging from 0 to 88 and higher scores indicating higher symptom severity.

Secondary outcomes

Resilience Scores

Time frame: 6 months

Done with Connor-Davidson Resiliency Scale. The Connor-Davidson Resilience Scale (CD-RISC) is a self-report questionnaire (commonly 25 items) assessing resilience, with total scores ranging from 0 to 100 and higher scores indicating greater resilience.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: COVIPACT 2

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Feb 10, 2021
Registry last updated: Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed