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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07541365
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wearable actigraphy — DEVICE
    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) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteClevelandOhio44195
Joel Saltzman, MD
Joel Saltzman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute· Cleveland, OH

Related Studies