CancerCOVID-TRAUMANCT04401046
COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
A study testing Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later in people with Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,096 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2020to 2 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Man or woman, age>18
- Diagnosis of cancer (solid tumor or hematology)
- Out patient or patient Under surveillance
Who cannot join
- Refusal to participate in the study
- Emergency, person deprived of liberty
- hospitalized patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence.
It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later.
Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.
- Conditions
- Cancer
- Being tested
- Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
- Keywords
- COVID-19, POST TRAUMATIC STRESS, CANCER, ANXIETY, REORGANISATION OF CARE
- Medical subject headings
- Neoplasms, COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey to assess Post traumatic stress and anxiety at inclusion and 6 months laterOther
The first survey will include questions relative to sociodemographic characteristics, existence of psychological troubles; living conditions in the Covid19 pandemic context; IES-R, Stait Trait Anxiety, and the fear of a cancer recurrence scales, satisfaction with cancer care and medical status of patients (diagnosis, ongoing treatment, follow-up of the disease).
| Study group | Role | What they receive |
|---|---|---|
| Post traumatic stress and anxiety evaluation | Experimental | Not described Receives: Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Impact of Event Scale Revisited scale
Measured: at inclusion and 6 months later
Secondary outcomes (7)
Factors associated with post-traumatic stress disorder
The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale
Measured: at inclusion and 6 months later
Measure of the patient's anxiety
The measure of anxiety, measured by the State-Trait Anxiety Questionnaire
Measured: at inclusion and 6 months later
proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.
Measured: at inclusion and 6 months later
proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19
Measured: at inclusion and 6 months later
proportion of patients stating that remote consultation is as useful as a face-to-face consultation
Measured: at inclusion and 6 months later
proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)
Measured: at inclusion and 6 months later
Score on the cancer recurrence scale
Measured: at inclusion and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start20 May 2020
- Primary completion26 Nov 2020
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,096 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenaelle GRAVIS, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401046
- Sponsor's protocol ID
- COVID-TRAUMA-IPC 2020-026
- Acronym
- COVID-TRAUMA
- Status last verified
- Jul 2021
- First submitted
- 22 May 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04401046
- Acronym / sponsor ID
- COVID-TRAUMA / COVID-TRAUMA-IPC 2020-026
- Conditions
- Cancer
- Keywords
- COVID-19, POST TRAUMATIC STRESS, CANCER, ANXIETY, REORGANISATION OF CARE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,096 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence.
It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later.
Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post traumatic stress and anxiety evaluation | Experimental | Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man or woman, age>18
- Diagnosis of cancer (solid tumor or hematology)
- Out patient or patient Under surveillance
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Emergency, person deprived of liberty
- hospitalized patient
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 |
|---|---|---|
| Survey to assess Post traumatic stress and anxiety at inclusion and 6 months laterThe first survey will include questions relative to sociodemographic characteristics, existence of psychological troubles; living conditions in the Covid19 pandemic context; IES-R, Stait Trait Anxiety, and the fear of a cancer recurrence scales, satisfaction with cancer care and medical status of patients (diagnosis, ongoing treatment, follow-up of the disease). | Other | Post traumatic stress and anxiety evaluation |
Primary outcome
Score of the Impact of Event Scale Revisited scale
Time frame: at inclusion and 6 months later
7 secondary outcomes
Factors associated with post-traumatic stress disorder
Time frame: at inclusion and 6 months later
Measure of the patient's anxiety
Time frame: at inclusion and 6 months later
proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.
Time frame: at inclusion and 6 months later
proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19
Time frame: at inclusion and 6 months later
proportion of patients stating that remote consultation is as useful as a face-to-face consultation
Time frame: at inclusion and 6 months later
proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)
Time frame: at inclusion and 6 months later
Score on the cancer recurrence scale
Time frame: at inclusion and 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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.
Gwenaelle GRAVIS, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later in people with Cancer, run by Institut Paoli-Calmettes 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 3 inclusion and 3 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 22 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score of the Impact of Event Scale Revisited scale (time frame: at inclusion and 6 months later). 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 22 Jul 2021.