Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester (EMBRaCE-GM)
Colorectal Cancer, Lung Cancer, Hematological Cancer
About this trial
This is an interventional device feasibility trial for Colorectal Cancer
Eligibility 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.
Sites / Locations
- Manchester University NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
1. Colorectal Cancer
2. Lung Cancer
3. Haematological Cancer
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.
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.
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