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Clinical Trials/NCT04768153
NCT04768153TerminatedNot Applicable

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

University Hospital Center of Martinique1 site in 1 country83 target enrollmentStarted: July 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
83
Locations
1
Primary Endpoint
Evaluation of Psychiatric disorders

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital Center of Martinique
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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