Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Lung Cancer; Hematological Cancer; CAR T-Cell Therapy
• Interventions: Device: OURA Ring; Device: WithingsScan Watch; Other: Quality of Life Surveys; Drug: Isansys Patient Status Engine; Diagnostic Test: Blood Samples; Other: Daily Weights

• Registration Number: NCT05099237
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2021-12-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Colorectal Cancer	OURA Ring	This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with colorectal cancer who are about to start treatment. Participants will be asked to: * Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months). * Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-C survey). * Report specific symptoms on an ad-hoc basis as they wish.
1. Colorectal Cancer	WithingsScan Watch	This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with colorectal cancer who are about to start treatment. Participants will be asked to: * Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months). * Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-C survey). * Report specific symptoms on an ad-hoc basis as they wish.
1. Colorectal Cancer	Quality of Life Surveys	This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with colorectal cancer who are about to start treatment. Participants will be asked to: * Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months). * Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-C survey). * Report specific symptoms on an ad-hoc basis as they wish.
2. Lung Cancer	OURA Ring	This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with lung cancer who are about to start treatment. Participants will be asked to: * Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months). * Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-L survey). * Report specific symptoms on an ad-hoc basis as they wish.
2. Lung Cancer	WithingsScan Watch	This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with lung cancer who are about to start treatment. Participants will be asked to: * Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months). * Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-L survey). * Report specific symptoms on an ad-hoc basis as they wish.
2. Lung Cancer	Quality of Life Surveys	This cohort seeks to investigate the feasibility of using two commercially available health and wellbeing trackers to monitor patients with lung cancer who are about to start treatment. Participants will be asked to: * Wear the OURA ring and the Withings ScanWatch for the duration of their planned cancer treatment up to a maximum of 26 weeks (6 months). * Complete weekly wearable device satisfaction surveys and weekly cancer specific patient reported outcomes measures (modified FACT-L survey). * Report specific symptoms on an ad-hoc basis as they wish.
3. Haematological Cancer	OURA Ring	Participants (with haematological malignancy about to start treatment with CAR T-cell therapy or another cellular therapy product) will be asked to: * Wear an OURA ring and Withings ScanWatch for approx five weeks including whilst they are in hospital (prior to CAR T-cell therapy and continue for 28 days post infusion) * Wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days. * Supported to take daily weights using Withings Body Scale. * Asked to complete weekly electronic quality of life surveys * Provide a series of 12 blood samples to measure inflammatory molecules at various intervals
3. Haematological Cancer	WithingsScan Watch	Participants (with haematological malignancy about to start treatment with CAR T-cell therapy or another cellular therapy product) will be asked to: * Wear an OURA ring and Withings ScanWatch for approx five weeks including whilst they are in hospital (prior to CAR T-cell therapy and continue for 28 days post infusion) * Wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days. * Supported to take daily weights using Withings Body Scale. * Asked to complete weekly electronic quality of life surveys * Provide a series of 12 blood samples to measure inflammatory molecules at various intervals
3. Haematological Cancer	Isansys Patient Status Engine	Participants (with haematological malignancy about to start treatment with CAR T-cell therapy or another cellular therapy product) will be asked to: * Wear an OURA ring and Withings ScanWatch for approx five weeks including whilst they are in hospital (prior to CAR T-cell therapy and continue for 28 days post infusion) * Wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days. * Supported to take daily weights using Withings Body Scale. * Asked to complete weekly electronic quality of life surveys * Provide a series of 12 blood samples to measure inflammatory molecules at various intervals
3. Haematological Cancer	Quality of Life Surveys	Participants (with haematological malignancy about to start treatment with CAR T-cell therapy or another cellular therapy product) will be asked to: * Wear an OURA ring and Withings ScanWatch for approx five weeks including whilst they are in hospital (prior to CAR T-cell therapy and continue for 28 days post infusion) * Wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days. * Supported to take daily weights using Withings Body Scale. * Asked to complete weekly electronic quality of life surveys * Provide a series of 12 blood samples to measure inflammatory molecules at various intervals
3. Haematological Cancer	Blood Samples	Participants (with haematological malignancy about to start treatment with CAR T-cell therapy or another cellular therapy product) will be asked to: * Wear an OURA ring and Withings ScanWatch for approx five weeks including whilst they are in hospital (prior to CAR T-cell therapy and continue for 28 days post infusion) * Wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days. * Supported to take daily weights using Withings Body Scale. * Asked to complete weekly electronic quality of life surveys * Provide a series of 12 blood samples to measure inflammatory molecules at various intervals
3. Haematological Cancer	Daily Weights	Participants (with haematological malignancy about to start treatment with CAR T-cell therapy or another cellular therapy product) will be asked to: * Wear an OURA ring and Withings ScanWatch for approx five weeks including whilst they are in hospital (prior to CAR T-cell therapy and continue for 28 days post infusion) * Wear an Isansys LifeTouch, Isansys LifeTemp and Nonin Model 3150 WristOx™ Pulse Oximeter during their inpatient stay only, up to a maximum of 28 days. * Supported to take daily weights using Withings Body Scale. * Asked to complete weekly electronic quality of life surveys * Provide a series of 12 blood samples to measure inflammatory molecules at various intervals

Primary Outcome Measures

Name	Time	Method
Cohort 3 - Primary outcome measure: feasibility of monitoring for the OURA ring and Withings ScanWatch:	5 weeks	The proportion of participants who completed 5 weeks of monitoring and the full period of monitoring (hospital admission to discharge, max 28 days) with the device (i.e:- did not request to remove the device early) as the amount of time vital signs were actually recorded by the device expressed as a percentage of the total duration of the participant's planned cancer treatment.
Cohort 3 - Primary outcome measure: feasibility of monitoring for the daily weights:	Maximum of 28 days	The number of daily weights recorded (inpatient stay, max 28 days)
Cohort 1/2 - Primary outcome measure: feasibility of monitoring for each wearable monitor (ring and watch):	Maximum of 6 months	The proportion of participants who completed the planned duration of monitoring with the device (ie:- did not request to terminate the study early) and the amount of time vital signs were actually recorded by the device expressed as a percentage of the total time the patient wore the device on the study.
Cohort 3 - Primary outcome measure: feasibility of monitoring for the Isansys medical devices LifeTouch, LifeTemp and Nonin Pulse Oximeter):	Maximum of 28 days	The proportion of participants who completed 5 weeks of monitoring and the full period of monitoring (hospital admission to discharge, max 28 days) with the device (i.e:- did not request to remove the device early) as the amount of time vital signs were actually recorded by the device expressed as a percentage of the total time the patient wore the device on the study.

Secondary Outcome Measures

Name	Time	Method
Cohorts 1,2 and 3 Device acceptability	through study completion, an average of 6 months	Participants will be asked to complete a weekly survey (via smart phone/tablet) to determine the acceptability of the devices to patients: - Likert scale ratings (pre-defined answer options, ranging from "very likely" through to "highly unlikely" on a 5-point scale) and free text comments concerning the extent to which the devices support self-management.

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom