COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,096
- 试验地点
- 2
- 主要终点
- Score of the Impact of Event Scale Revisited scale
研究概览
简要总结
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence.
It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later.
Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman, age>18
- •Diagnosis of cancer (solid tumor or hematology)
- •Out patient or patient Under surveillance
排除标准
- •Refusal to participate in the study
- •Emergency, person deprived of liberty
- •hospitalized patient
结局指标
主要结局
Score of the Impact of Event Scale Revisited scale
时间窗: at inclusion and 6 months later
次要结局
- Score on the cancer recurrence scale(at inclusion and 6 months later)
- proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19(at inclusion and 6 months later)
- proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)(at inclusion and 6 months later)
- Factors associated with post-traumatic stress disorder(at inclusion and 6 months later)
- Measure of the patient's anxiety(at inclusion and 6 months later)
- proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.(at inclusion and 6 months later)
- proportion of patients stating that remote consultation is as useful as a face-to-face consultation(at inclusion and 6 months later)