Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
Summary
NIH's ClinicalTrials.gov registered a single-arm pilot study (NCT07541365) at Cleveland Clinic Novel Therapeutics Clinic evaluating wearable sensor-based monitoring and electronic patient-reported outcomes in Phase I oncology clinical trials. The study will assess feasibility and acceptability of integrating digital health technologies into early-phase cancer clinical trials, enrolling participants already in early phase trials.
What changed
This ClinicalTrials.gov entry documents a prospective single-arm pilot study at Cleveland Clinic Novel Therapeutics Clinic. The study evaluates feasibility and acceptability of wearable sensor-based monitoring combined with electronic patient-reported outcomes in Phase I oncology clinical trials. For healthcare providers and clinical investigators, this represents a forward-looking approach to integrating digital health technologies into early-phase cancer research. The study aims to establish a foundation for larger-scale prospective studies, though this registration alone creates no compliance obligations.
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Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
N/A NCT07541365 Kind: NA Apr 21, 2026
Abstract
Wearable sensors offer opportunities to improve the people's experiences with cancer treatment and to improve care delivery. This is a single-arm, prospective, unblinded pilot study designed to evaluate the feasibility and acceptability of wearable sensor-based monitoring and incorporating electronic patient-reported outcomes (ePROs) in Phase I oncology clinical trials. The study will enroll participants enrolled in early phase clinical trials at the Cleveland Clinic Novel Therapeutics Clinic and aims to establish the foundation for future, larger-scale prospective studies integrating digital health technologies into early-phase cancer clinical trials. Participants will be offered a smartwatch device compatible to their phone's operating system and be guided through the installation and use of the researchers' free study mobile application. Participants already owning compatible smartwatch devices may elect to use their own smartwatch for the study.
Conditions: Cancer
Interventions: Wearable actigraphy, Electronic Patient-Reported Outcomes (ePROs)
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