Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

• Status: Not yet recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Aptus Clinical Ltd.; GM Cancer; The Christie NHS Foundation Trust; University of Manchester; Zenzium AI Ltd.

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.