Wake Forest University Health Sciences
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring.
This randomized pilot study is designed to evaluate the efficacy of a continuous temperature-monitoring wearable patch in patients receiving CAR-T therapy in the outpatient setting, comparing its performance to standard institutional monitoring protocols.
Inclusion Criteria: Patients: 1. Ability to understand and willingness to sign an IRB-approved informed consent 2. Age ≥ 18 years at the time of consent 3. Scheduled to undergo CAR-T therapy in the outpatient setting at AHWFBCCC 4. Ability to read and understand the English and/or Spanish language 5. As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study 6. Access to a mobile device for the duration of the trial Provider/Staff: Provider/staff participants must meet all of the following inclus…
Patient participants will receive instruction from a research designee regarding use of the TempShield patch and smartphone application for continuous at-home temperature monitoring. Patient participants will complete onboarding of the application on their smartphone with assistance from the research designee, if necessary. Patient participants should place the patch immediately after completion of CAR-T infusion in the outpatient setting, with assistance from the research designee.
Standard of care oral temperature monitoring
Arctuva estimate
Actual pay is set by the research site.
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