Recruiting

Wearable Sensors

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07541365

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wearable actigraphy

Electronic Patient-Reported Outcomes (ePROs)

Study Details

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.

Conditions

Cancer

Study ID

NCT07541365

Start date

Jul 8, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Wearable Actigraphy + ePROs

Participants will wear an actigraphy and complete electronic patient-reported outcomes (ePROs) questionnaires on a mobile application (app) called OncoJourney for 4 weeks.

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.

Primary outcome measure

  • Feasibility of integrating wearable actigraphy monitoring in early phase oncology clinical trials, as measured by proportion of participants [ Time Frame: 4 weeks ]
  • Feasibility of integrating electronic patient-reported outcomes (ePROs) in early phase oncology clinical trials, , as measured by proportion of participants [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Joel Saltzman, MD

440-312-4569saltzmj@ccf.org

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Joel Saltzman, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • Phase 1 Clinical Trials
  • Actigraphy
  • Wearable

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-04.