Prioritising Prevention of COVID-19 in Persons With Cancer in the French West Indies

Cancer Clinical Trial

— RESILIENCE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04768153
• Other study ID #: 20_RIPH3_04
• Status: Active, not recruiting
• Start date: July 15, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• Serology
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

Locations

Country	Name	City	State
Martinique	CHU Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after implementation of confinement in France
Primary	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	6 months after implementation of confinement in France