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

NCT07541365 | Not Yet Recruiting DMC

• 1 other identifier: CASE14Z25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Phase 1 Clinical Trials; Actigraphy; Wearable

Outcome Measures

Primary Outcomes (2)

• Feasibility of integrating wearable actigraphy monitoring in early phase oncology clinical trials, as measured by proportion of participants

  Feasibility of integrating wearable actigraphy monitoring is defined by the proportion of participants who wear the device for a median of at least 12 hours per day per week over 4 weeks.

  4 weeks

• Feasibility of integrating electronic patient-reported outcomes (ePROs) in early phase oncology clinical trials, , as measured by proportion of participants

  Feasibility of integrating electronic patient-reported outcomes (ePROs) is defined by the proportion of participants who complete at least 80% of scheduled ePRO assessments over 4 weeks.

  4 weeks

Secondary Outcomes (3)

• Differences in clinician-reported and participant-reported symptoms, as measured by the ePRO-CTCAE

  4 weeks

• Difference in time (days) from study enrollment to first occurrence of a Grade ≥1 adverse event, as based on clinician-reported CTCAE versus participant-reported ePRO-CTCAE.

  4 weeks

• Qualitative experience of the participants with respect to usability of the mobile app and wearable device during the study

  4 weeks

Study Arms (1)

Wearable Actigraphy + ePROs

EXPERIMENTAL

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

Device: Wearable actigraphy; Other: Electronic Patient-Reported Outcomes (ePROs)

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.

Wearable Actigraphy + ePROs

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.

Wearable Actigraphy + ePROs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Upper limb amputation, extensive tattoos, or lymphedema that may interfere with actigraphy data collection.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. JOP. 2017;13(2):82-89. doi:10.1200/jop.2016.016857

  BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). European Journal of Cancer. 2009;45(2):228-247. doi:10.1016/j.ejca.2008.10.026

  BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Joel Saltzman, MD

  Case Comprehensive Cancer Center, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Saltzman, MD

CONTACT

440-312-4569; saltzmj@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)