Remote Monitoring of Cancer Patients With Suspected Covid-19

NCT04397705 | Unknown Phase 1

• 1 other identifier: CFTSp186
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

COVID; Oncology; Haematological Malignancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Device Tolerability (Questionnaire)

  Questionnaire at three weeks

• Device Tolerability (Semi-structured interviews)

  One to four weeks after completion of wearing the device

• Reliability of data transmission

  Over three weeks of patients wearing devices

Study Arms (1)

Ambulatory monitoring

EXPERIMENTAL

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

Interventions

Patient Status Engine DEVICE

Wearable sensors

Ambulatory monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients hospitalized for more than 24 hours at initial presentation with symptoms consistent with Covid-19.
• Pregnant patients.
• Patients unable to give informed consent.
• 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.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M204BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• John Radford

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wes Dale

CONTACT

01614463000; wes.dale@christie.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm open label study.

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 21, 2020
• Study Start: October 12, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)