跳至主要内容
临床试验/NCT04768153
NCT04768153终止不适用

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 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
83
试验地点
1
主要终点
Evaluation of Psychiatric disorders

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Evaluation of Psychiatric disorders

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验