Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Zenzium AI Ltd.

  collaborator UNKNOWN

• Aptus Clinical Ltd.

  collaborator UNKNOWN

• The Christie NHS Foundation Trust

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• GM Cancer

  collaborator UNKNOWN

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Dr Anthony Wilson · Manchester University NHS Foundation Trust

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• United Kingdom

Study Locations