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

Primary Purpose

Solid Carcinoma, Post Traumatic Stress Disorder, Covid19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychological support
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Francois Baclesse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychological support

Arm Description

Monthly psychological support

Outcomes

Primary Outcome Measures

Proportion of patients with improvement in post-traumatic stress symptoms

Secondary Outcome Measures

Resilience Scores
Done with Connor-Davidson Resiliency Scale

Full Information

First Posted
February 8, 2021
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT04747249
Brief Title
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19
Acronym
COVIPACT 2
Official Title
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Carcinoma, Post Traumatic Stress Disorder, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Psychological support
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychological support
Arm Type
Experimental
Arm Description
Monthly psychological support
Intervention Type
Other
Intervention Name(s)
Psychological support
Intervention Description
Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.
Primary Outcome Measure Information:
Title
Proportion of patients with improvement in post-traumatic stress symptoms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Resilience Scores
Description
Done with Connor-Davidson Resiliency Scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antony NARAYANASSAMY, M
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Francois Baclesse
City
Caen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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