Remote Monitoring of Cancer Patients With Suspected Covid-19
Հիմնաբառեր
Վերացական
Նկարագրություն
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.
Ամսաթվերը
| Վերջին ստուգումը: | 04/30/2020 |
| Առաջինը ներկայացվում է: | 05/19/2020 |
| Մոտավոր գրանցումը ներկայացված է: | 05/19/2020 |
| Առաջին տեղադրումը: | 05/20/2020 |
| Վերջին թարմացումը ներկայացված է: | 05/19/2020 |
| Վերջին թարմացումը տեղադրված է: | 05/20/2020 |
| Ուսումնասիրության իրական մեկնարկի ամսաթիվը: | 05/31/2020 |
| Նախնական ավարտման նախնական ամսաթիվը: | 07/31/2020 |
| Ուսումնասիրության ավարտի գնահատման ամսաթիվը: | 09/30/2020 |
Վիճակ կամ հիվանդություն
Միջամտություն / բուժում
Device: Ambulatory monitoring
Փուլ
Arm խմբերը
| Արմ | Միջամտություն / բուժում |
|---|---|
| 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: Ambulatory monitoring Wearable sensors |
Իրավասության չափանիշներ
| Ուսման իրավունք ունեցող դարաշրջանները | 18 Years Դեպի 18 Years |
| Ուսումնասիրության իրավունք ունեցող սեռերը | All |
| Ընդունում է առողջ կամավորներ | Այո |
| Չափանիշներ | 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. |
Արդյունք
Արդյունքների առաջնային միջոցառումներ
1. Device Tolerability (Attrition) [Three weeks]
2. Correlation of physiological data with clinical events [Over three weeks of patients wearing devices]
Արդյունքների երկրորդական միջոցներ
1. Device Tolerability (Questionnaire) [Questionnaire at three weeks]
2. Device Tolerability (Semi-structured interviews) [One to four weeks after completion of wearing the device]
3. Reliability of data transmission [Over three weeks of patients wearing devices]
