Remote Monitoring of Patients at Risk of Sepsis

NCT04260230 | Withdrawn

• 1 other identifier: CFTSp172
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neutropenia, Febrile; Cancer; Sepsis

Outcome Measures

Primary Outcomes (1)

• Device tolerability

  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 if the data collected was being used to monitor my health during chemotherapy'. This statement is included in the questionnaires completed at the end of the device wearing period.

  Questionnaire at six weeks.

Secondary Outcomes (3)

• Reliability of data transmission

  Over six weeks of patients wearing devices.

• Interim device tolerability

  Questionnaire at three weeks.

• Semi-structured interviews

  One to four weeks after completion of wearing the device.

Other Outcomes (1)

• Correlation of physiological data with clinical events

  Over 6 weeks of patients wearing devices.

Study Arms (1)

Lifetemp/Lifetouch sensors

EXPERIMENTAL

Participants will be asked to wear the sensors for six weeks. Data will be collected from the devices but will only be reviewed retrospectively and will not be used to alter participants care in any way.

Device: Lifetemp/Lifetouch sensors

Interventions

Lifetemp/Lifetouch sensors DEVICE

Wearing the devices for six weeks. Data only reviewed retrospectively.

Also known as: Patient Status Engine

Lifetemp/Lifetouch sensors

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

You may not qualify if:

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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• Isansys Lifecare LTD: collaborator
• University of Manchester: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M204BX, United Kingdom

Location

MeSH Terms

Conditions

Febrile Neutropenia; Neoplasms; Sepsis

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm open label device tolerability study.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: February 7, 2020
• Study Start: March 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 19, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)