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

Study Overview

• Status: Recruiting
• Conditions: COVID; Oncology; Haematological Malignancy
• Intervention / Treatment: Device: Patient Status Engine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wes Dale; Phone Number: 7902 01614463000; Email: wes.dale@christie.nhs.uk

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M204BX
      • Recruiting
      • The Christie NHS Foundation Trust
      • Contact: Wes Dale; Phone Number: +44 1619187902; Email: Wes.dale@christie.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participants are capable of giving informed consent
2. Male or female aged 18 or over

3. 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
4. Emergency presentation to hospital with symptoms consistent with Covid-19 deemed to meet the criteria for Covid-19 testing by admitting clinician.
5. Deemed by the admitting clinician to be suitable for outpatient management of suspected Covid-19.
6. Stable oxygen saturations of 95% or higher at time of emergency presentation.
7. Able to complete tolerability questionnaire.
8. Able and willing to comply with twice daily pulse oximetry monitoring as outlined in section 6 of the protocol.
9. ECOG-PS <4
10. Life expectancy of greater than three months as assessed by screening investigator from review of electronic patient record.

Exclusion Criteria:

1. Patients hospitalized for more than 24 hours at initial presentation with symptoms consistent with Covid-19.
2. Pregnant patients.
3. Patients unable to give informed consent.
4. 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.
5. 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.
6. History of allergy or contact dermatitis to medical adhesives e.g sticking plasters, ECG electrodes.
7. Patients with pacemakers, implantable defibrillators or neurostimulators.
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Patient Status Engine; Wearable sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Tolerability (Attrition)	Percentage of patients who choose to stop wearing the devices before they have completed the study	Three weeks
Correlation of physiological data with clinical events	Correlation of sensor collected data with clinical episodes of infection. Sensor collected data includes heart rate, respiratory rate and temperature.	Over three weeks of patients wearing devices

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Tolerability (Questionnaire)	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.	Questionnaire at three weeks
Device Tolerability (Semi-structured interviews)	Device tolerability as assessed by semi-structured interviews.	One to four weeks after completion of wearing the device
Reliability of data transmission	Reliable data transmission to central hospital system expressed as a percentage of total data points collected out of target data points collected.	Over three weeks of patients wearing devices

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Investigators: Principal Investigator: John Radford, The University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: CFTSp186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The physiological data represents a rich clinical data resource which has the potential to be valuable in other contexts to answer future unanticipated questions. We therefore propose storing this pseudoanonymised data in a Data Bank with a lifespan initially of five years with potential for extension if appropriate ethical approval is gained. This Data Bank could then be used, under ethical approval for other research in order to maximise the potential utility of the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No