Remote Monitoring of Cancer Patients With Suspected Covid-19 (RECAP)
Remote Monitoring of Cancer Patients Presenting With Symptoms Suggestive of Covid-19 - Pilot Phase.
Since emerging in December 2019, coronavirus disease 2019 (Covid-19) has developed into an unprecedented global pandemic. The causative pathogen, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has the potential to cause a wide range of clinical syndromes, from fever, dyspnoea and cough to respiratory failure and cardiac injury necessitating critical care support. A number of patients have a more indolent clinical course and can be safely managed in the community.
Characterising the clinical course of Covid-19 infection in the oncology population and distinguishing this from other acute oncology presentations which can mimic Covid-19 is a key unmet research need. Current standard of care for monitoring patients at high risk of chemotherapy associated neutropenic sepsis involves asking them to contact their cancer centre when they feel unwell or develop a fever. No standard of care for monitoring ambulatory Covid-19 patients has yet been established. We hypothesise that using wearable biosensors to detect patients who exhibit 'red flags' for sepsis or deterioration due to Covid-19 may allow earlier assessment and intervention. There is no current evidence for wearable biosensors in ambulatory patients receiving chemotherapy, and there is no existing research into this proposed use of biosensors in patients with suspected or confirmed Covid-19 infection.
In order to justify performing a randomised controlled study comparing standard of care with biosensor driven monitoring it is important to establish the tolerability and validity of these devices. We aim to collect patient reported outcome measures (PROMs) on tolerability and assess the reliability of data transmission to a central data collection server. We will also perform an initial analysis of physiological data and correlation with clinical events
研究概览
详细说明
This is a pilot, single arm, open label feasibility study. This is a single centre trial based in a large tertiary cancer centre which treats patients across all solid and haematological malignancies. Patients will be recruited from all disease groups.
Patients who present with symptoms suspicious for Covid-19 who the admitting clinicians deems appropriate for outpatient management will be considered for this study.
Patients who are enrolled will undergo continuous physiological monitoring for up to three weeks. This includes continuous monitoring of heart rate, respiratory rate, temperature, activity levels (by accelerometer measurement) and twice daily pulse oximetry. The physiological data will not be reviewed in real time by clinicians and therefore will not be used to alter patients' standard care. The pulse oximetry data will be visible to patients who will be given clear guidelines to follow with regards to contacting the cancer centre hotline should values deviate from baseline.
In the pilot phase of RECAP 10-30 patients will each be monitored for up to 3 weeks and the following endpoints will be addressed:
Physiological trends and interactions predictive of clinical deterioration due to COVID-19 (Co-primary endpoint) Reliability of biosensor data collection/transmission using digital technology from patients self-isolating at home (Co-primary endpoint) Acceptability and tolerability of wearable biosensors and continuous monitoring If the pilot phase is successful we will move to a phase II study in a larger number of patients where the objective will be to refine a physiological signature predictive of clinical deterioration in COVID-19 patients so that early hospitalisation and relevant medical interventions can be arranged.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Wes Dale
- 电话号码：7902 01614463000
- 邮箱：wes.dale@christie.nhs.uk
学习地点
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Greater Manchester
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Manchester、Greater Manchester、英国、M204BX
- 招聘中
- The Christie NHS Foundation Trust
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接触：
- Wes Dale
- 电话号码：+44 1619187902
- 邮箱：Wes.dale@christie.nhs.uk
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants are capable of giving informed consent
- Male or female aged 18 or over
Diagnosis of any solid tumour or haematological malignancy meeting one of the following criteria:
- Current malignant diagnosis
- Received anti-cancer treatment within the last two years
- Emergency presentation to hospital with symptoms consistent with Covid-19 deemed to meet the criteria for Covid-19 testing by admitting clinician.
- Deemed by the admitting clinician to be suitable for outpatient management of suspected Covid-19.
- Stable oxygen saturations of 95% or higher at time of emergency presentation.
- Able to complete tolerability questionnaire.
- Able and willing to comply with twice daily pulse oximetry monitoring as outlined in section 6 of the protocol.
- ECOG-PS <4
- Life expectancy of greater than three months as assessed by screening investigator from review of electronic patient record.
Exclusion Criteria:
- Patients hospitalized for more than 24 hours at initial presentation with symptoms consistent with Covid-19.
- Pregnant patients.
- Patients unable to give informed consent.
- Presence of ulceration or pre-existing skin rash at site of device application (left precordium and axillae). If only one axilla affected this is not an exclusion criterion if patient is happy to apply temperature sensor to the other axilla.
- Radiotherapy to the left chest wall either during or within the six months preceding the study. Plans for subsequent radiotherapy to commence after study completion are not an exclusion criterion. If only one axilla is within the planned radiotherapy field and patient is happy to apply temperature sensor to the other axilla this is not an exclusion criteria.
- History of allergy or contact dermatitis to medical adhesives e.g sticking plasters, ECG electrodes.
- Patients with pacemakers, implantable defibrillators or neurostimulators.
- Patients who are currently receiving treatment as part of a clinical study or have had their end of treatment visit for another clinical study less than 30 days prior to the study enrollment visit.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ambulatory monitoring
Participants will be asked to wear the sensors (heart rate, respiratory rate, temperature, and pulse oximetry) for three weeks.
Data will be collected from the devices but will only be reviewed retrospectively and will not be used to alter participants care.
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Wearable sensors
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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 |
|---|---|---|
|
Device Tolerability (Attrition)
大体时间：Three weeks
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Percentage of patients who choose to stop wearing the devices before they have completed the study
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Three weeks
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Correlation of physiological data with clinical events
大体时间：Over three weeks of patients wearing devices
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Correlation of sensor collected data with clinical episodes of infection.
Sensor collected data includes heart rate, respiratory rate and temperature.
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Over three weeks of patients wearing devices
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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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Device Tolerability (Questionnaire)
大体时间：Questionnaire at three weeks
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Percentage of participants who answer 'agree' or 'strongly agree' on a five point Likert scale to the statement 'I would be happy to wear the sensors again for the next three weeks'.
This statement is included in the questionnaires completed after three weeks of wearing the device.
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Questionnaire at three weeks
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Device Tolerability (Semi-structured interviews)
大体时间：One to four weeks after completion of wearing the device
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Device tolerability as assessed by semi-structured interviews.
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One to four weeks after completion of wearing the device
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Reliability of data transmission
大体时间：Over three weeks of patients wearing devices
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Reliable data transmission to central hospital system expressed as a percentage of total data points collected out of target data points collected.
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Over three weeks of patients wearing devices
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合作者和调查者
调查人员
- 首席研究员：John Radford、The University of Manchester
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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