RECAP - Remote monitoring of Cancer Patients With Suspected Covid-19 [COVID-19]

• Research type

  Research Study

• Full title

  Remote monitoring of cancer patients presenting with symptoms suggestive of COVID-19: RECAP (pilot phase) \n

• IRAS ID

  282489

• Contact name

  John Radford

• Contact email

  john.radford@manchester.ac.uk

• Sponsor organisation

  The Christie NHS Foundation Trust

• ISRCTN Number

  ISRCTN12345678

• Clinicaltrials.gov Identifier

  NCT12345678

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  Research Summary
  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. \n\nCharacterising 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.\nIn 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\n

  Summary of Results

  Lay summary of study results: The RECAP study evaluated whether wearable sensors can be used to monitor cancer patients with confirmed or suspected COVID 19, but who are well enough to remain at home. The Isansys Patient Status Engine, which has sensors that measure heart rate, respiratory rate and temperature continuously, and oxygen saturation levels intermittently, was employed in the study. We wanted to find out if the devices were tolerable and acceptable to patients, if the transmission of data from the patients’ home to the hospital was reliable, and if the sensors could allow earlier detection of patients who were becoming unwell, allowing earlier treatment and a better outcome.

  A total of 19 patients were approached of whom 8 declined recruitment and 3 were found to be ineligible. Eight patients (2 male, 6 female) were therefore recruited. Participants wore the devices for up to 21 days. We successfully established a secure connection for real time transmission of data from the participant worn sensors into the hospital system. Two participants wore the devices for the full trial period, two participants were withdrawn as they were re-admitted to hospital with worsening symptoms and four participants decided to withdraw early due to feeling overwhelmed by their cancer and Covid 19 diagnoses, difficulty with working the devices, or discomfort due to skin irritation around the sensors.
  
  Six participants completed a questionnaire at the end of the trial and seven took part in an interview about their experience. The results showed that participants liked the idea of wearing sensors to monitor their health. The majority did not find the sensors uncomfortable or that wearing them impacted on daily life such as showering/ sleep/intimacy or wearing clothes. However, some participants experienced usability issues with the technology. There was also a concern amongst some patients that wearing the sensors made them more anxious about their health because of raised awareness. Participants did not have concerns about data security.

  Initial analysis of the sensor data for one of the participants who became unwell has shown increasing respiratory and heart rate two days prior to the decrease in oxygen saturations that was the trigger for hospital admission. This finding requires further investgation but suggests that wearable biosensors might help identify patients who are becoming unwell at an earlier stage than current practice, allowing earlier intervention.

  The RECAP project was undertaken by a team of clinicians and academics from the Christie NHS Foundation Trust and the University of Manchester. The Research was funded by the Christy Charity COVID 19 Research Fund and by the Lymphoma Team at the Christie. Technical support and some of the sensor equipment was provided free of charge by Isansys Lifecare.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  20/EE/0114

• Date of REC Opinion

  27 Apr 2020

• REC opinion

  Further Information Favourable Opinion