Clinical trial · Interventional
Remote Monitoring of Cancer Patients With Suspected Covid-19
Remote Monitoring of Cancer Patients Presenting With Symptoms Suggestive of Covid-19 - Pilot Phase.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID | — | UNRESOLVED | — |
| Haematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Status Engine | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ambulatory monitoring
- 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.
- interventionNames
- Device: Patient Status Engine
Primary outcomes (2)
- measure
- Device Tolerability (Attrition)
- timeFrame
- Three weeks
- description
- Percentage of patients who choose to stop wearing the devices before they have completed the study
- measure
- Correlation of physiological data with clinical events
- timeFrame
- Over three weeks of patients wearing devices
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available