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

Summary

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.

Eligibility

Inclusion Criteria:

* Age ≥18 years at the time of enrollment
* Access to a mobile phone running iOS (X or more recent) or Android 14 (or more recent)
* Ability to connect their mobile phone with their existing or provided smartwatch
* Ability to read and understand English
* Referred to the Novel Therapeutics Clinic and enrolled in an early-phase clinical trial
* Ability to demonstrate the use of a mobile device and application for electronic patient-reported outcome (ePRO) completion
* Willingness to wear an actigraphy device for 4 weeks, at least 12 hours per day over four weeks.
* Ability to provide informed consent.

Exclusion Criteria:

* Upper limb amputation, extensive tattoos, or lymphedema that may interfere with actigraphy data collection.

Conditions1

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