Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers (COVIPACT)
2020年12月11日 更新者：Centre Francois Baclesse
This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus.
We will also assess the psychological impact of the pandemic in patients but also in caregivers
研究概览
研究类型
观察性的
注册 (实际的)
809
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Caen、法国
- Centre Francois Baclesse
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Rouen、法国
- Centre Henri Becquerel
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
2 populations were recruted in this study : patients with cancer and caregivers
描述
Inclusion Criteria:
For Patients:
- Adult patient, treated for a solid or hematological tumor
- will be treated ou actually treated by oncological treatment carried out at the hospital in day unit of the participating centers: treatment initiated before or during the pandemic with COVID-19
For the Caregivers:
- Medical oncologist, hematologist, intern, nurse and caregiver in day unit of hospital
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
照顾者
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delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
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病人
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delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy
大体时间：up to 6 months
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Proportion of patients with modification of the treatments administered
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up to 6 months
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To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy
大体时间：up to 6 months
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Proportion of patients with change in the rate of treatment administration
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up to 6 months
|
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To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy
大体时间：up to 6 months
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Proportion of patients with change in the number of cures administered
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up to 6 months
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To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy
大体时间：up to 6 months
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Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)
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up to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate the perceived stress on cancer patients treated in unit day of hospital
大体时间：up to 12 months
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Score of questionnaires of Perceived Stress Scale [0-40 points]
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up to 12 months
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Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital
大体时间：up to 12 months
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Score of questionnaires of Impact of Event Scale-Revised [0-88 points]
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up to 12 months
|
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Evaluate the sleep disorders on cancer patients treated in unit day of hospital
大体时间：up to 12 months
|
Score of questionnaires of sleep disorders (ISI scale, 0-28 points)
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up to 12 months
|
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Evaluate the quality of life on cancer patients treated in unit day of hospital
大体时间：up to 12 months
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Score of questionnaires of quality of life (FACT-G scale)
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up to 12 months
|
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Evaluate the cognitive complaints on cancer patients treated in unit day of hospital
大体时间：up to 12 months
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Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)
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up to 12 months
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Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
大体时间：up to 12 months
|
Score of questionnaires of Perceived Stress Scale [0-40 points]
|
up to 12 months
|
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Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
大体时间：up to 12 months
|
Score of questionnaires of Impact of Event Scale-Revised [0-88 points]
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up to 12 months
|
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Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
大体时间：up to 12 months
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Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)
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up to 12 months
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Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)
大体时间：up to 12 months
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Score of questionnaires of feeling of personal effectiveness (0-30 points)
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up to 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年4月15日
初级完成 (实际的)
2020年7月15日
研究完成 (预期的)
2021年5月1日
研究注册日期
首次提交
2020年4月16日
首先提交符合 QC 标准的
2020年4月27日
首次发布 (实际的)
2020年4月28日
研究记录更新
最后更新发布 (实际的)
2020年12月14日
上次提交的符合 QC 标准的更新
2020年12月11日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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