Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials (NCT07541365) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
United States30 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of integrating wearable actigraphy monitoring in early phase oncology clinical trials, as measured by proportion of participants
Timeframe: 4 weeks
2
Feasibility of integrating electronic patient-reported outcomes (ePROs) in early phase oncology clinical trials, , as measured by proportion of participants