NCT05099237

Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

A Multi-cohort Trial to Investigate the Feasibility and Acceptability of Wearable Vital Signs Monitors in Patients Undergoing Cancer Treatment in Greater Manchester.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Lung Cancer
• Hematological Cancer
• CAR T-Cell Therapy

Interventions

Type	Name	Description
DEVICE	OURA Ring	All participants will be asked to wear an OURA ring and WithingsScan Watch both at home and whilst in hospital. These devices can record activity, sleep type and duration, resting heart rate and heart rate variability along with a range of other vital signs.
DEVICE	WithingsScan Watch	All participants will be asked to wear an OURA ring and WithingsScan Watch both at home and whilst in hospital. These devices can record activity, sleep type and duration, resting heart rate and heart rate variability along with a range of other vital signs.
DRUG	Isansys Patient Status Engine	Participants in cohort 3 will also be asked to wear Isansys monitoring devices whilst they are in hospital. They will begin to wear the monitors prior to CAR T-cell therapy and continue for 28 days post infusion. Participants will be asked to 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.
OTHER	Quality of Life Surveys	On a weekly basis participants will be asked to complete satisfaction surveys for the devices they are wearing (ring and watch) and report on their quality of life through standardised questionnaires. These surveys will be delivered electronically to participants via their smartphone or tablet device. There will be an option for participants to report adhoc symptoms via an app on their smartphone or tablet device.
DIAGNOSTIC_TEST	Blood Samples	COHORT 3 ONLY Participants in Cohort 3 only will be asked to provide a series of blood samples to measure inflammatory molecules during the study. These will be requested at various intervals during face-to-face visits and whilst the patient is in hospital: * Baseline blood sample during study enrolment * Post-lymphodepletion and prior to CAR T-cell infusion (this may be on day -1 or day 0 as needed) * Post CAR T-cell infusion: * Day 1 * Day 3 * Day 6 * Day 9 * Day 14 (if the participant remains in hospital) A sample of blood will be taken at baseline and a further sample post lymphodepletion and prior to CAR T-cell infusion. Post CAR T-cell infusion, samples will be taken at two timepoints (morning and afternoon) on each of the sampling days.
OTHER	Daily Weights	COHORT 3 ONLY During their inpatient stay, up to a maximum of 28 days, participants in Cohort 3 will be supported to weigh themselves daily using a Withings Body Scale.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-10-29
• Last updated: 2023-05-03

Locations

1 site across 1 country: United Kingdom