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Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
Sponsor: Case Comprehensive Cancer Center
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-07
Completion Date
2027-01
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
Wearable actigraphy
Participants will wear an actigraphy for 4 weeks. Participants who already use a smartwatch may opt to utilize their smartwatch for actigraphy monitoring during the study period (4 weeks) instead.
Electronic Patient-Reported Outcomes (ePROs)
Participants will complete a weekly ePRO questionnaire on the mobile application (app) called OncoJourney. The 26-item questionnaire will ask about symptom burden for the previous 7 days. Questions will be answered on a 5-point Likert scale. Higher scores indicate greater symptoms. Participants will complete one questionnaire per week for 4 weeks.
Locations (1)
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States