Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

NCT05099237 | Unknown DMC

• 1 other identifier: B01227
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Cohort 1/2 - Primary outcome measure: feasibility of monitoring for each wearable monitor (ring and watch):

  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.

  Maximum of 6 months

• Cohort 3 - Primary outcome measure: feasibility of monitoring for the OURA ring and Withings ScanWatch:

  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.

  5 weeks

• Cohort 3 - Primary outcome measure: feasibility of monitoring for the Isansys medical devices LifeTouch, LifeTemp and Nonin Pulse Oximeter):

  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.

  Maximum of 28 days

• Cohort 3 - Primary outcome measure: feasibility of monitoring for the daily weights:

  The number of daily weights recorded (inpatient stay, max 28 days)

  Maximum of 28 days

Secondary Outcomes (5)

• Cohorts 1,2 and 3 Device acceptability

  through study completion, an average of 6 months

• Cohorts 1,2 and 3 Device acceptability

  through study completion, an average of 6 months

• Cohorts 1,2 and 3 Device acceptability

  through study completion, an average of 6 months

• Cohorts 1,2 and 3 Device acceptability

  through study completion, an average of 6 months

• Cohorts 1,2 and 3 Device acceptability

  through study completion, an average of 6 months

Study Arms (3)

1. Colorectal Cancer

ACTIVE COMPARATOR

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.

Device: OURA Ring; Device: WithingsScan Watch; Other: Quality of Life Surveys

2. Lung Cancer

ACTIVE COMPARATOR

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.

Device: OURA Ring; Device: WithingsScan Watch; Other: Quality of Life Surveys

3. Haematological Cancer

ACTIVE COMPARATOR

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

Device: OURA Ring; Device: WithingsScan Watch; Drug: Isansys Patient Status Engine; Other: Quality of Life Surveys; Diagnostic Test: Blood Samples; Other: Daily Weights

Interventions

OURA Ring DEVICE

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.

1. Colorectal Cancer; 2. Lung Cancer; 3. Haematological Cancer

WithingsScan Watch DEVICE

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.

1. Colorectal Cancer; 2. Lung Cancer; 3. Haematological Cancer

Isansys Patient Status Engine DRUG

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.

3. Haematological Cancer

Quality of Life Surveys OTHER

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.

1. Colorectal Cancer; 2. Lung Cancer; 3. Haematological Cancer

Blood Samples DIAGNOSTIC_TEST

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.

3. Haematological Cancer

Daily Weights OTHER

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.

3. Haematological Cancer

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Zenzium AI Ltd.: collaborator
• Aptus Clinical Ltd.: collaborator
• The Christie NHS Foundation Trust: collaborator
• University of Manchester: collaborator
• GM Cancer: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dr Anthony Wilson

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayley Brooks

CONTACT

0161 291 4409; hayley.brooks@mft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: October 29, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)