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

NCT04747249 | Completed Results

• 1 other identifier: 2020-A03234-35
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Carcinoma; Post Traumatic Stress Disorder; Covid19

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Improvement in Post-traumatic Stress Symptoms

  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.

  6 months

Secondary Outcomes (1)

• Resilience Scores

  6 months

Study Arms (1)

Psychological support

EXPERIMENTAL

Monthly psychological support

Other: Psychological support

Interventions

Psychological support OTHER

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

Psychological support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre Francois Baclesse

Caen, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; COVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: François Christy
• Organization: Centre François Baclesse

f.christy@baclesse.unicancer.fr

0231450002

Study Officials

• Antony NARAYANASSAMY, M

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Psychological support

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 10, 2021
• Study Start: June 18, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 5, 2022
• Last Updated: July 31, 2026
• Results First Posted: June 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)