Last updated: May 2, 2023
Sponsor: Manchester University NHS Foundation Trust
Overall Status: Active - Recruiting
Phase
N/A
Condition
Colorectal Cancer
Lung Cancer
Blood Cancer
Treatment
Blood Samples
Daily Weights
OURA Ring
Clinical Study ID
NCT05099237
B01227
Ages > 16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: All individuals who participate in the EMBRaCE-GM study will have capacity to consent toenrol in the study at the point of screening and consent. This is an inclusion criteria forthe study. Cohort 1 - Individuals are eligible to be included in the study only if all the following criteriaapply:
- 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 proposedtreatment plan.
- Owns a smart phone/tablet compatible with the OURA ring and Withings ScanWatch and iswilling 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 OURAand Withings apps.
- Capable of charging and managing the wearable sensors (OURA ring and WithingsScanWatch) at home Cohort 2 - Individuals are eligible to be included in the study only if all of the following criteriaapply:
- 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 proposedtreatment plan.
- Owns a smart phone/tablet compatible with the OURA ring and Withings ScanWatch and iswilling 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 OURAand Withings apps.
- Capable of charging and managing the wearable sensors (OURA ring and WithingsScanWatch) at home Cohort 3 - Individuals are eligible to be included in the study only if all the following criteriaapply: Adult (aged 16 years or older)
- Consented to receive a CAR T-cell therapy or other cellular therapy product fortreatment of a haematological malignancy.
- The individual is aware of the confirmed diagnosis and understands the proposedtreatment plan.
- Owns a smart phone/tablet compatible with the OURA ring and Withings ScanWatch/SmartScale 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 OURAand Withings apps.
- Capable of charging and managing the wearable sensors (OURA ring and WithingsScanWatch) at home
Exclusion
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 followinginstructions and using the wearable device correctly/as instructed.
- Patients for whom there is no suitably sized OURA ring or Withings ScanWatch availableat the time of screening*.
- Patients who are non-English speakers - an essential requirement to interact with thewearable 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 followinginstructions and using the wearable device correctly/as instructed.
- Patients for whom there is no suitably sized OURA ring or Withings ScanWatch availableat the time of screening*.
- Patients who are non-English speakers - an essential requirement to interact with thewearable 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 WithingsScanWatches 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 ofparticipants can be easily accommodated but on rare occasions a suitably sized device maynot be available.
Study Design
Total Participants: 80
Treatment Group(s): 6
Primary Treatment: Blood Samples
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Manchester University NHS Foundation Trust
Manchester, M13 9WU
United KingdomActive - Recruiting
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