Remote Monitoring of Patients at Risk of Sepsis

Chemotherapy is used to treat cancer in many thousands of patients per annum in the United Kingdom and millions worldwide. Most chemotherapy suppresses bone marrow function and causes a low white cell count (neutropenia) which is a major cause of sepsis, a potentially fatal medical emergency. Best outcomes in sepsis result from early admission to hospital with the rapid start of antibiotics and supportive care. Currently, patients starting chemotherapy are told the importance of making contact with the hospital if they feel unwell or develop a high temperature. Despite this it is common for patients to delay telephoning the Cancer Centre "hot line" until after enduring many hours of symptoms and ultimately being admitted to hospital very unwell and sometimes in life threatening septic shock. This proposal (REACT) seeks to invert the current model of care with the aim of improving patient outcomes whilst reducing costs. In this proof of concept pilot study the investigators aim to assess the feasibility of using remote wearable biosensors to record key physiological parameters (including respiratory rate, heart rate and temperature) and transmit this data centrally to The Christie. The investigators will also assess retrospectively whether perturbations in biosensor collected data correlate with clinical episodes of sepsis and if so develop bespoke clinical algorithms to identify patients displaying "red flags" for sepsis and guide response. Data collected by the sensors is at this stage only being reviewed retrospectively. Subsequent phases would involve recruiting larger number of patients to develop and test these algorithms with patients exhibiting 'red flags' for sepsis being contacted by the clinical team and taking appropriate action to facilitate assessment and treatment. The results of this study will determine whether working towards a randomised phase III trial comparing REACT with standard of care is an appropriate next step.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Participants are capable of giving informed consent
2. Male or female aged 18 or over
3. Diagnosis of malignancy including:

   * Lung cancer (including both small and non-small cell lung cancers)
   * Upper gastrointestinal malignancy
   * Haematological malignancy (lymphoma, leukaemia and myeloma)
4. Planned to commence chemotherapy OR undergoing chemotherapy in an outpatient setting as standard of care treatment with at least two cycles of treatment remaining.
5. Able to complete tolerability questionnaires.
6. Eastern Cooperative Oncology Group Performance Status \<4
7. Life expectancy of greater than three months.

Exclusion Criteria:

1. Patients hospitalized at time of commencing chemotherapy
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 Visit 1 are ineligible.
9. Patients who have planned foreign travel during the study period.