Clinical trial NCT04768153: Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Psychiatry
Public health
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients followed at the Martinique University Hospital

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who are unable to answer the study questionnaires
* Patients who do not speak fluent French
* Persons under legal protection

Primary outcomes:
measure: Evaluation of Psychiatric disorders
timeFrame: 3 months after implementation of confinement in France
measure: Evaluation of Psychiatric disorders
timeFrame: 6 months after implementation of confinement in France
Secondary outcomes:
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: CHU Martinique
Study officials:
References: