Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials

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.

NCT Number	NCT07541365
Lead Sponsor	Case Comprehensive Cancer Center
Conditions	Cancer
Enrollment	30 participants
Start Date	2026-07-08
Primary Completion	2026-12 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-04