Solid CarcinomaCOVIPACT 2NCT04747249
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19
A study testing Psychological support in people with Solid Carcinoma and Post Traumatic Stress Disorder, run by Centre Francois Baclesse at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Carcinoma, Post Traumatic Stress Disorder, Covid19
- What is being tested?
- Psychological support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2021to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Psychological support
- Medical subject headings
- Stress Disorders, Post-Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological supportOther
Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Psychological support | Experimental | Monthly psychological support Receives: Other: Psychological support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start18 Jun 2021
- Primary completion31 Mar 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Psychological support
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antony NARAYANASSAMY, M, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747249
- Sponsor's protocol ID
- 2020-A03234-35
- Acronym
- COVIPACT 2
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2021
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19
- ClinicalTrials.gov ID
- NCT04747249
- Acronym / sponsor ID
- COVIPACT 2 / 2020-A03234-35
- Conditions
- Solid Carcinoma, Post Traumatic Stress Disorder, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Psychological support
| Arm | Type | Receives |
|---|---|---|
| Psychological support | Experimental | Other: Psychological supportMonthly psychological support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological supportPsychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months. | Other | Psychological support |
Primary outcome
Proportion of Patients With Improvement in Post-traumatic Stress Symptoms
Time frame: 6 months
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.
1 secondary outcome
Resilience Scores
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antony NARAYANASSAMY, M principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological support in people with Solid Carcinoma and Post Traumatic Stress Disorder, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Improvement in Post-traumatic Stress Symptoms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.