CancerRESILIENCENCT04768153
Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies
An observational study of Cancer, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
The public health council (Haut Conseil de Santé Publique) published a statement on 14 March 2020 relating to the management of patients with severe forms of COVID-19, stipulating specific recommendations for patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Serology
- How many people
- 83 participants
- Where
- 1 siteMartinique
- Study dates
- 15 Jul 2020to 25 Sep 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancer patients followed at the Martinique University Hospital
Who may be able to join
- Patients aged 18 years or older living in the French West Indies
- Patient with prevalent cancer of the prostate, breast, lung, colon or rectum
- Patients who receive the information leaflet and do not express any opposition to the use of their personal medical data
Who cannot join
- Patients who are unable to answer the study questionnaires
- Patients who do not speak fluent French
- Persons under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies: Monitoring Psychological Impact to Optimize Healthcare Delivery Strategies in Unique Public Health Circumstances
The public health council (Haut Conseil de Santé Publique) published a statement on 14 March 2020 relating to the management of patients with severe forms of COVID-19, stipulating specific recommendations for patients with cancer.
The statement notes that patients with cancer at much higher risk (four to five times higher) of several respiratory complications, which develop very rapidly, especially if they had recently undergone surgery or chemotherapy in the previous few weeks, and that this risk could be life-threatening, on top of the cancer-related risk. In addition, the statement noted that:
Read more
- COVID-19 appears to be more frequent in patients with cancer than among the general population (1% vs 0.29%)
- Among those infected, the risk of severe respiratory complications requiring admission to the intensive care unit (ICU) is higher in patients with cancer than among those without (39% vs 8%, P=0.0003).
- A history of chemotherapy or surgery in the previous months is an important prognostic factor for the development of severe respiratory complications (odds ratio (OR) = 5.34, P= 0.0026).
- Deterioration of respiratory function occurs more quickly in patients with cancer (13 vs 43 days, hazard ratio (HR) 3.56, 95% confidence interval (CI) [1.65-7.69]).
In addition, COVID-19 may lead to a change in the diagnostic and therapeutic management of patients with cancer, with potential consequences such as use of oral treatments at home, discontinuation of anticancer therapy depending on the context, or prioritization of management according to curative/palliative treatment type, age, and line of therapy.
International studies previously reported the psychological repercussions of major epidemics on the emotional state. The impact of COVID-19 on patients with cancer therefore warrants evaluation, among cancer patients in the French West Indies, in the current situation of nationwide lockdown.
- Conditions
- Cancer
- Being tested
- Serology
- Keywords
- Psychiatry, Public health
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerologyBiological
Serological diagnosis of COVID-19 in patients with cancer from a sample of cancer patients, at 3 and 6 months after implementation of confinement in France
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Biological: Serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Psychiatric disorders
Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic
Measured: 3 months after implementation of confinement in France
Evaluation of Psychiatric disorders
Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic
Measured: 6 months after implementation of confinement in France
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start15 Jul 2020
- Primary completion31 Dec 2021
- Study completion25 Sep 2023
Why it stopped: Poor recruitment
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768153
- Sponsor's protocol ID
- 20_RIPH3_04
- Acronym
- RESILIENCE
- Status last verified
- Aug 2024
- First submitted
- 9 Feb 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies: Monitoring Psychological Impact to Optimize Healthcare Delivery Strategies in Unique Public Health Circumstances
- ClinicalTrials.gov ID
- NCT04768153
- Acronym / sponsor ID
- RESILIENCE / 20_RIPH3_04
- Conditions
- Cancer
- Keywords
- Psychiatry, Public health
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 24 Feb 2021 (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 public health council (Haut Conseil de Santé Publique) published a statement on 14 March 2020 relating to the management of patients with severe forms of COVID-19, stipulating specific recommendations for patients with cancer.
The statement notes that patients with cancer at much higher risk (four to five times higher) of several respiratory complications, which develop very rapidly, especially if they had recently undergone surgery or chemotherapy in the previous few weeks, and that this risk could be life-threatening, on top of the cancer-related risk. In addition, the statement noted that:
- COVID-19 appears to be more frequent in patients with cancer than among the general population (1% vs 0.29%)
- Among those infected, the risk of severe respiratory complications requiring admission to the intensive care unit (ICU) is higher in patients with cancer than among those without (39% vs 8%, P=0.0003).
- A history of chemotherapy or surgery in the previous months is an important prognostic factor for the development of severe respiratory complications (odds ratio (OR) = 5.34, P= 0.0026).
- Deterioration of respiratory function occurs more quickly in patients with cancer (13 vs 43 days, hazard ratio (HR) 3.56, 95% confidence interval (CI) [1.65-7.69]).
In addition, COVID-19 may lead to a change in the diagnostic and therapeutic management of patients with cancer, with potential consequences such as use of oral treatments at home, discontinuation of anticancer therapy depending on the context, or prioritization of management according to curative/palliative treatment type, age, and line of therapy.
International studies previously reported the psychological repercussions of major epidemics on the emotional state. The impact of COVID-19 on patients with cancer therefore warrants evaluation, among cancer patients in the French West Indies, in the current situation of nationwide lockdown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: Serology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients followed at the Martinique University Hospital
Key inclusion criteria (3 listed)
- Patients aged 18 years or older living in the French West Indies
- Patient with prevalent cancer of the prostate, breast, lung, colon or rectum
- Patients who receive the information leaflet and do not express any opposition to the use of their personal medical data
Key exclusion criteria (3 listed)
- Patients who are unable to answer the study questionnaires
- Patients who do not speak fluent French
- Persons under legal protection
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 |
|---|---|---|
| SerologySerological diagnosis of COVID-19 in patients with cancer from a sample of cancer patients, at 3 and 6 months after implementation of confinement in France | Biological | Patients |
Primary outcome
Evaluation of Psychiatric disorders
Time frame: 3 months after implementation of confinement in France
Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic
Evaluation of Psychiatric disorders
Time frame: 6 months after implementation of confinement in France
Evaluation of presence of psychiatric disorders by questionnaire after the initiation of population-level confinement due to the COVID-19 epidemic
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital Center of Martinique at 1 site in Martinique.
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: stopped early, as of the sponsor's last update on 21 Aug 2024. 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 Martinique. 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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
Evaluation of Psychiatric disorders (time frame: 3 months after implementation of confinement in France). The study lists 2 primary outcomes in all. 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 21 Aug 2024.