Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19 (COVIPACT 2)

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 study initiated at the François Baclesse Centre during the first confinement, which included 735 patients from April to June 2020, made it possible to assess the impact of the pandemic linked to COVID-19 on the care of cancer patients treated in day hospitals, but also to evaluate the PTSD experienced by patients, sleep difficulties, quality of life, cognitive complaints and confinement conditions using validated questionnaires. This study showed that 21% of patients had proven PTSD and 23% had insomnia problem.

This study proposes to evaluate the value of adapted psychological care for patients with PTSD in relation to the pandemic on the improvement of PTSD, as well as on resilience, quality of life and sleep.

Study Overview

• Status: Completed
• Conditions: Covid19; Post Traumatic Stress Disorder; Solid Carcinoma
• Intervention / Treatment: Other: Psychological support

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Centre François Baclesse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychological support; Monthly psychological support	Other: Psychological support; Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with improvement in post-traumatic stress symptoms	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience Scores	Done with Connor-Davidson Resiliency Scale	6 months

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Investigators: Principal Investigator: Antony NARAYANASSAMY, M, Centre François Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): September 5, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; COVID-19; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2020-A03234-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No