RecruitingNot ApplicableNCT07541365

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

Sponsor

Case Comprehensive Cancer Center

Enrollment

30 participants

Start Date

Jul 8, 2026

Study Type

INTERVENTIONAL

Conditions

Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Electronic Patient-Reported Outcomes (ePROs) and a medical device called Wearable actigraphy for people with cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWearable 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.

OTHERElectronic 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.