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

Covid19 Clinical Trial

— COVIPACT 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747249
• Other study ID #: 2020-A03234-35
• Status: Completed
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 5, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Post Traumatic Stress Disorder
• Solid Carcinoma
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
France	Centre Francois Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with improvement in post-traumatic stress symptoms		6 months
Secondary	Resilience Scores	Done with Connor-Davidson Resiliency Scale	6 months