Back to results

Remote Monitoring of Cancer Patients With Suspected Covid-19 (RECAP)

Primary Purpose

COVID, Oncology, Haematological Malignancy

Status

Unknown status

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Patient Status Engine

About this trial

This is an interventional other trial for COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Christie NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ambulatory monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

Device Tolerability (Attrition)

Percentage of patients who choose to stop wearing the devices before they have completed the study

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.

Secondary Outcome Measures

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.

Device Tolerability (Semi-structured interviews)

Device tolerability as assessed by semi-structured interviews.

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.

Full Information

NCT ID

NCT04397705

First Posted

May 20, 2020

Last Updated

February 9, 2021

Sponsor

The Christie NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT04397705

Brief Title

Remote Monitoring of Cancer Patients With Suspected Covid-19

Acronym

RECAP

Official Title

Remote Monitoring of Cancer Patients Presenting With Symptoms Suggestive of Covid-19 - Pilot Phase.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 12, 2020 (Actual)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Christie NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID, Oncology, Haematological Malignancy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Single arm open label study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ambulatory monitoring

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Patient Status Engine

Intervention Description

Wearable sensors

Primary Outcome Measure Information:

Title

Device Tolerability (Attrition)

Description

Percentage of patients who choose to stop wearing the devices before they have completed the study

Time Frame

Three weeks

Title

Correlation of physiological data with clinical events

Description

Correlation of sensor collected data with clinical episodes of infection. Sensor collected data includes heart rate, respiratory rate and temperature.

Time Frame

Over three weeks of patients wearing devices

Secondary Outcome Measure Information:

Title

Device Tolerability (Questionnaire)

Description

Time Frame

Questionnaire at three weeks

Title

Device Tolerability (Semi-structured interviews)

Description

Device tolerability as assessed by semi-structured interviews.

Time Frame

One to four weeks after completion of wearing the device

Title

Reliability of data transmission

Description

Reliable data transmission to central hospital system expressed as a percentage of total data points collected out of target data points collected.

Time Frame

Over three weeks of patients wearing devices

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wes Dale

Phone

01614463000

Ext

7902

wes.dale@christie.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Radford

Organizational Affiliation

The University of Manchester

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Christie NHS Foundation Trust

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M204BX

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wes Dale

Phone

1619187902

Ext

+44

Wes.dale@christie.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

Remote Monitoring of Cancer Patients With Suspected Covid-19

We'll reach out to this number within 24 hrs