NCT07541365 Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
| NCT ID | NCT07541365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-07-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-07-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Joel Saltzman, MD
PRINCIPAL INVESTIGATOR
Case Comprehensive Cancer Center, Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07541365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541365 currently recruiting?
Yes, NCT07541365 is actively recruiting participants. Contact the research team at saltzmj@ccf.org for enrollment information.
Where is the NCT07541365 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07541365 clinical trial?
NCT07541365 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Joel Saltzman, MD at Case Comprehensive Cancer Center, Cleveland Clinic. The trial plans to enroll 30 participants.
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