Clinical trial NCT05099237: Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester
Official title: A Multi-cohort Trial to Investigate the Feasibility and Acceptability of Wearable Vital Signs Monitors in Patients Undergoing Cancer Treatment in Greater Manchester.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lung Cancer
Hematological Cancer
CAR T-Cell Therapy
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Zenzium AI Ltd.
name: Aptus Clinical Ltd.
name: The Christie NHS Foundation Trust
name: University of Manchester
name: GM Cancer
First posted: 2021-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The EMBRaCE-GM study is a multi-cohort trial designed to efficiently evaluate the range of wearable vital signs monitors. Each cohort is a distinct group of patients who undertake a feasibility study.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The EMBRaCE-GM study is a multi-cohort trial designed to efficiently evaluate the range of wearable vital signs monitors that could be used to support patients during cancer treatment.

The aims of the study are to determine

* to determine if continuous vital signs monitoring is feasible during cancer treatment
* to determine if such monitoring is acceptable to patients undergoing cancer treatment
* to determine what insights could be made with the data obtained

A multi-cohort study is essential because there are a huge range of vital signs monitors that could be useful and a method that allows quickly identification of the devices that are most acceptable to patients and which offer the most useful information to clinicians is needed. Similarly, the best device may vary according to the specific disease and the treatment a patient is offered.

Each cohort in the study will investigate a variety of wearable vital signs monitors in different patient groups undergoing different treatments. A common data collection platform will be used for all cohorts with a modular design that allows data collection to be adapted slightly to meet specific needs for each cohort.

Detailed description: 1 in 2 people will be diagnosed with cancer during their lifetime with over 350,000 new cancer diagnoses per year (UK). Cancer treatment is a complex process. Patients experience a range of symptoms as a consequence of their disease and their treatment. Sometimes, the treatment itself can lead to specific life-threatening complications.Patients who recover may be left with lasting physical and psychological consequences. A third of those who are suffering from cancer or who have recovered from it classify their health as 'average to poor' which is double the rate reported by individuals without health problems. There is an ongoing need to offer patients personalised support through their cancer journey and to identify and minimise complications.

This need for personalised cancer care is emphasised in the NHS Long Term Plan (2019). A key aim of which is to improve cancer survival but with a focus on giving patients 'more control over their health' through improved self-management. The long-term plan identifies a need for digitally-enabled care to empower patients and highlights that artificial intelligence (AI) and digital clinical decision support could play a role in this regard.

Wearable vital signs monitors offer a solution by which patients can be monitored more frequently and in more detail during cancer treatment. There is a huge variety of wearable monitors which range from commercially available well-being trackers to CE marked medical devices. The devices themselves take many forms which may vary in their acceptability to patients and utility to health care professionals. The parameters which can be monitored range from traditional vital signs to more holistic measures of sleep, stress and activity. Such information could help to identify individuals who are recovering well, those who are experiencing specific symptoms or those who need extra assistance.

The availability of commercial well-being monitors is growing rapidly and monitors are becoming progressively more sophisticated. Monitors are also increasingly used in medical research in conjunction with or in place of formal medical devices. This trend has been highlighted in a recent systematic review in which the authors noted the need for further research to understand the validity and acceptability of using such devices in an outpatient healthcare setting. This is particularly true for patients suffering from cancer, where the vast majority of wearable device research has focused upon exercise trackers, the breast cancer tumour type and patients who have already completed their cancer treatment. In addition, the acceptability of such devices to patients has been shown to vary. The COMPARE study reported that patients are broadly supportive of artificial intelligence (AI) and wearable devices whilst a study in patient genitourinary cancer found that acceptability of wearable devices varied between 100% (40-49 years) and 40% (80-89 years).

The situation is broadly the same for wearable vital signs monitors which are registered as medical devices. Whilst these devices have been more extensively studied, the majority of research does not pertain to cancer patients and no specific use case has been identified in this patient population.

Therefore, before wearable vital signs monitors can play a role in cancer care it is essential that the acceptability of the range of devices is formally evaluated in a variety of cancer types, in a broad demographic of patients, over the duration of cancer treatment and in a variety of treatment modalities and settings. The investigators aim to understand the potential of these devices to offer new insights and learn if the information provided can be useful to patients and healthcare professionals.

Eligibility criteria: Inclusion Criteria:

All individuals who participate in the EMBRaCE-GM study will have capacity to consent to enrol in the study at the point of screening and consent. This is an inclusion criteria for the study.

Cohort 1 -

Individuals are eligible to be included in the study only if all the following criteria apply:

* Adult (aged 16 years or older)
* Diagnosis of colorectal cancer confirmed at MDT
* Active treatment planned which must include surgery
* The individual is aware of the confirmed diagnosis and understands the proposed treatment plan.
* Owns a smart phone/tablet compatible with the OURA ring and Withings ScanWatch and is willing to have the OURA app and Withings app installed on their device.
* The patient has an email account or is willing to create one to register with the OURA and Withings apps.
* Capable of charging and managing the wearable sensors (OURA ring and Withings ScanWatch) at home

Cohort 2 -

Individuals are eligible to be included in the study only if all of the following criteria apply:

* Adult (aged 16 years or older)
* Diagnosis of lung cancer confirmed at MDT
* Active treatment planned
* The individual is aware of the confirmed diagnosis and understands the proposed treatment plan.
* Owns a smart phone/tablet compatible with the OURA ring and Withings ScanWatch and is willing to have the OURA app and Withings app installed on their device.
* The patient has an email account or is willing to create one to register with the OURA and Withings apps.
* Capable of charging and managing the wearable sensors (OURA ring and Withings ScanWatch) at home

Cohort 3 -

Individuals are eligible to be included in the study only if all the following criteria apply:

Adult (aged 16 years or older)

* Consented to receive a CAR T-cell therapy or other cellular therapy product for treatment of a haematological malignancy.
* The individual is aware of the confirmed diagnosis and understands the proposed treatment plan.
* Owns a smart phone/tablet compatible with the OURA ring and Withings ScanWatch/Smart Scale and is willing to have the OURA app and Withings app installed on their device.
* The patient has an email account or is willing to create one to register with the OURA and Withings apps.
* Capable of charging and managing the wearable sensors (OURA ring and Withings ScanWatch) at home

Exclusion Criteria:

Cohort 1 \& Cohort 2 -

Individuals are excluded from the study if any of the following criteria apply:

* Patients unable to give informed consent.
* Patients in whom treatment is limited to "best supportive care"
* Patients with cognitive or sensory deficits that would prevent them from following instructions and using the wearable device correctly/as instructed.
* Patients for whom there is no suitably sized OURA ring or Withings ScanWatch available at the time of screening\*.
* Patients who are non-English speakers - an essential requirement to interact with the wearable device apps and complete the web-based surveys that form part of the study.

Cohort 3 -

Individuals are excluded from the study if any of the following criteria apply:

* Patients unable to give informed consent.
* Patients in whom treatment is limited to "best supportive care"
* Known allergy or history of contact dermatitis to medical adhesives.
* Patients with pacemakers, implantable defibrillators or neurostimulators.
* Patients with prion related diseases e.g., Spongiform Encephalopathies
* Patients with cognitive or sensory deficits that would prevent them from following instructions and using the wearable device correctly/as instructed.
* Patients for whom there is no suitably sized OURA ring or Withings ScanWatch available at the time of screening\*.
* Patients who are non-English speakers - an essential requirement to interact with the wearable device apps and complete the web-based surveys that form part of the study.

For all cohorts -

\* It is essential that participants wear appropriately sized OURA rings and Withings ScanWatches to ensure that they are comfortable and that the data collected is accurate. The study has purchased enough rings and watches to ensure that the majority of participants can be easily accommodated but on rare occasions a suitably sized device may not be available.

Primary outcomes:
measure: Cohort 1/2 - Primary outcome measure: feasibility of monitoring for each wearable monitor (ring and watch):
timeFrame: Maximum of 6 months
measure: Cohort 3 - Primary outcome measure: feasibility of monitoring for the OURA ring and Withings ScanWatch:
timeFrame: 5 weeks
measure: Cohort 3 - Primary outcome measure: feasibility of monitoring for the Isansys medical devices LifeTouch, LifeTemp and Nonin Pulse Oximeter):
timeFrame: Maximum of 28 days
measure: Cohort 3 - Primary outcome measure: feasibility of monitoring for the daily weights:
timeFrame: Maximum of 28 days
Secondary outcomes:
measure: Cohorts 1,2 and 3 Device acceptability
timeFrame: through study completion, an average of 6 months
measure: Cohorts 1,2 and 3 Device acceptability
timeFrame: through study completion, an average of 6 months
measure: Cohorts 1,2 and 3 Device acceptability
timeFrame: through study completion, an average of 6 months
measure: Cohorts 1,2 and 3 Device acceptability
timeFrame: through study completion, an average of 6 months
measure: Cohorts 1,2 and 3 Device acceptability
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Dr Anthony Wilson
role: PRINCIPAL_INVESTIGATOR
References: