Neutropenia, FebrileREACTNCT04260230
Remote Monitoring of Patients at Risk of Sepsis
A study testing Lifetemp/Lifetouch sensors in people with Neutropenia, Febrile and Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia, Febrile, Cancer, Sepsis
- What is being tested?
- Lifetemp/Lifetouch sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2022to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- Patients hospitalized at time of commencing chemotherapy
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M204BX
About this study
Official title: Remote Monitoring of Cancer Patients at Risk of Sepsis, a Pilot Study of Using Wearable Biosensors in Patients at High Risk of Chemotherapy Associated Neutropenic 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.
Read the detailed description
This is a pilot, single arm, open label feasibility study. There will be no change in patient's clinical care. Physiological data will only be analysed retrospectively.
This is a single centre trial based in a large tertiary cancer centre that treats patients across all solid tumour and haematological malignancies. Patients will be recruited from lymphoma, haematology, lung and upper gastrointestinal disease groups.
All study procedures will be performed by a researcher who is appropriately trained and who has been delegated by the PI to undertake this activity (and this is clearly documented on the delegation log). No study specific procedures will take place prior to written informed consent being provided. Study Schedule (Main Study)
The main study will consist of the following visits:
Screening Visit 1 on day one of a cycle of planned standard of care chemotherapy. This visit will include application of the wearable biosensors and training in how to use the devices including cautions and safety advice. Participants will be provided with a diary to document any issues with the device or periods where the sensors are removed. This visit will include a standard of care review by the participant's direct care team. Visit 2 on day 1 of the next cycle of chemotherapy(3 weeks after Visit 1). This visit will include a review of any device related issues by the study team and completion of the relevant event checklist (version 1.0). The study diary will be reviewed. Used sensors will be collected and replacement sensors provided. The participant will be asked to complete an interim tolerability questionnaire. This visit will include a standard of care review by the participant's direct care team. Visit 3 on day 22 of either cycle 2, 3, or 4 (3 weeks after Visit 2). This visit will include a review of any device related issues by the study team and completion of the relevant event checklist (version 1.0). The study diary will be reviewed.
Used sensors will be collected. The participant will be asked to complete an end of study tolerability questionnaire.
This visit will include a standard of care review by the participant's direct care team.
Structured interview 1-4 weeks post Visit 3 with between 10 and 20 selected participants. This visit will take place either at the Christie in a private non-clinical space or via telephone, according to the participant's preference. The IRAS Form Reference: IRAS Version 5.13 Date: 9 DRAFT interview is expected to take approximately 30 minutes. This is a semi-structured interview which will follow the interview schema (version 1.0) Sub-study: This study will consist of one visit where the participant will be shown the sensors and explained how the investigators are intending to use them. They will then be asked to complete a questionnaire about how they feel about the sensors.
- Conditions
- Neutropenia, Febrile, Cancer, Sepsis
- Being tested
- Lifetemp/Lifetouch sensors
- Medical subject headings
- Febrile Neutropenia, Neoplasms, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifetemp/Lifetouch sensorsDevice
Also called Patient Status Engine
Wearing the devices for six weeks. Data only reviewed retrospectively.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lifetemp/Lifetouch sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Questionnaire at six weeks.
Secondary outcomes (3)
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.
Measured: Over six weeks of patients wearing devices.
Interim 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 for the next three weeks'. This statement is included in the questionnaires completed after three weeks of wearing the device.
Measured: Questionnaire at three weeks.
Semi-structured interviews
Device tolerability as assessed by semi-structured interviews.
Measured: One to four weeks after completion of wearing the device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study startMar 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completion19 Dec 2024
Why it stopped: Withdrawn without opening to recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenia, FebrileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm open label device tolerability study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Isansys Lifecare LTD, University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260230
- Sponsor's protocol ID
- CFTSp172
- Acronym
- REACT
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2020
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Cancer Patients at Risk of Sepsis, a Pilot Study of Using Wearable Biosensors in Patients at High Risk of Chemotherapy Associated Neutropenic Sepsis
- ClinicalTrials.gov ID
- NCT04260230
- Acronym / sponsor ID
- REACT / CFTSp172
- Conditions
- Neutropenia, Febrile, Cancer, Sepsis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn without opening to recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Isansys Lifecare LTD, University of Manchester
- Study start
- Mar 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot, single arm, open label feasibility study. There will be no change in patient's clinical care. Physiological data will only be analysed retrospectively.
This is a single centre trial based in a large tertiary cancer centre that treats patients across all solid tumour and haematological malignancies. Patients will be recruited from lymphoma, haematology, lung and upper gastrointestinal disease groups.
All study procedures will be performed by a researcher who is appropriately trained and who has been delegated by the PI to undertake this activity (and this is clearly documented on the delegation log). No study specific procedures will take place prior to written informed consent being provided. Study Schedule (Main Study)
The main study will consist of the following visits:
Screening Visit 1 on day one of a cycle of planned standard of care chemotherapy. This visit will include application of the wearable biosensors and training in how to use the devices including cautions and safety advice. Participants will be provided with a diary to document any issues with the device or periods where the sensors are removed. This visit will include a standard of care review by the participant's direct care team. Visit 2 on day 1 of the next cycle of chemotherapy(3 weeks after Visit 1). This visit will include a review of any device related issues by the study team and completion of the relevant event checklist (version 1.0). The study diary will be reviewed. Used sensors will be collected and replacement sensors provided. The participant will be asked to complete an interim tolerability questionnaire. This visit will include a standard of care review by the participant's direct care team. Visit 3 on day 22 of either cycle 2, 3, or 4 (3 weeks after Visit 2). This visit will include a review of any device related issues by the study team and completion of the relevant event checklist (version 1.0). The study diary will be reviewed.
Used sensors will be collected. The participant will be asked to complete an end of study tolerability questionnaire.
This visit will include a standard of care review by the participant's direct care team.
Structured interview 1-4 weeks post Visit 3 with between 10 and 20 selected participants. This visit will take place either at the Christie in a private non-clinical space or via telephone, according to the participant's preference. The IRAS Form Reference: IRAS Version 5.13 Date: 9 DRAFT interview is expected to take approximately 30 minutes. This is a semi-structured interview which will follow the interview schema (version 1.0) Sub-study: This study will consist of one visit where the participant will be shown the sensors and explained how the investigators are intending to use them. They will then be asked to complete a questionnaire about how they feel about the sensors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm open label device tolerability study.
| Arm | Type | Receives |
|---|---|---|
| Lifetemp/Lifetouch sensors | Experimental | Device: Lifetemp/Lifetouch sensorsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants are capable of giving informed consent
- Male or female aged 18 or over
- Diagnosis of malignancy including:
- 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.
Key exclusion criteria (9 listed)
- Patients hospitalized at time of commencing chemotherapy
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifetemp/Lifetouch sensorsAlso: Patient Status EngineWearing the devices for six weeks. Data only reviewed retrospectively. | Device | Lifetemp/Lifetouch sensors |
Primary outcome
Device tolerability
Time frame: Questionnaire at six weeks.
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.
3 secondary outcomes
Reliability of data transmission
Time frame: Over six weeks of patients wearing devices.
Interim device tolerability
Time frame: Questionnaire at three weeks.
Semi-structured interviews
Time frame: One to four weeks after completion of wearing the device.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifetemp/Lifetouch sensors in people with Neutropenia, Febrile and Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device tolerability (time frame: Questionnaire at six weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.