Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychological support | Experimental | Monthly psychological support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological support | Other | Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resilience Scores | 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. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antony NARAYANASSAMY, M | Centre François Baclesse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Francois Baclesse | Caen | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients aged ≥18 years, treated or followed for a solid tumor at Centre François Baclesse, and presenting moderate to high post-traumatic stress symptoms (score ≥24 on the Impact of Event Scale-Revised (IES-R)) related to the COVID-19 epidemic.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Psychological Support | Monthly psychological support |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients included were described at baseline
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Psychological Support | Monthly psychological support |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at inclusion in years | All patients included were described at baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Among the included patients, 4 patients did not participate at at least 2 sessions and 3 end the study prematurely (2 deaths and 1 patient decision). | Posted | Count of Participants | Participants | 6 months |
|
6 months
No adverse event were collected in this study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psychological Support | Monthly psychological support | 2 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| François Christy | Centre François Baclesse | 0231450002 | f.christy@baclesse.unicancer.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2022 | May 27, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
Not provided
Not provided
Psychological support
Not provided
Not provided
Not provided
Not provided
| Median |
| Full Range |
| Years |
|
| Sex: Female, Male | Biological sex | All patients included were described at baseline. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Resilience Scores | 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. | Among the included patients, 5 patients end the study prematurely (2 deaths and 5 patient decision). | Posted | Median | Full Range | Score range 0 to 100 | 6 months |
|
|
|
| 29 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |