Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
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.
Description
In oncology, clinicians and researchers look at a person's clinical condition and functional status to understand how cancer and its treatment affect them. They use standardized rating scales to measure side effects from the disease or treatment. These scales grade how severe symptoms are based on factors such as the need for medical care, hospital stays, and whether a person can carry out daily activities. Standard grading systems are commonly used in oncology to measure treatment- and disease-related side effects. These systems assign levels of severity based on clinical criteria, such as w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
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.
Location
- Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteCleveland, Ohio