Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester

NAUnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Colorectal CancerLung CancerHematological CancerCAR 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."

Trial Locations (1)

M13 9WU

RECRUITING

Manchester University NHS Foundation Trust, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Zenzium AI Ltd.

UNKNOWN

collaborator

Aptus Clinical Ltd.

UNKNOWN

collaborator

The Christie NHS Foundation Trust

OTHER

collaborator

University of Manchester

OTHER

collaborator

GM Cancer

UNKNOWN

lead

Manchester University NHS Foundation Trust

OTHER_GOV

NCT05099237 - Enhanced Monitoring for Better Recovery and Cancer Experience in Greater Manchester | Biotech Hunter | Biotech Hunter