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

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Wearable actigraphy
  • Electronic Patient-Reported Outcomes (ePROs)

Treatment groups

30 Participants
are divided into 1 treatment group