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Wearable Sensors and ePROs in Early Phase Cancer Trials

This study is looking at how well wearable sensors and electronic patient-reported outcomes (ePROs) work in early-stage cancer clinical trials. You would wear a device called an actigraphy, which tracks your activity, for four weeks. If you already have a smartwatch, you might be able to use that instead. You would also answer a weekly questionnaire on a mobile app called OncoJourney about your symptoms over the past seven days. The main goal is to see if it's practical and acceptable to use these tools to understand how cancer and its treatments affect people. This study is for adults aged 18 or older who are already enrolled in an early-phase clinical trial at the Cleveland Clinic Novel Therapeutics Clinic, have a compatible smartphone, and can read English. The current recruitment status is unclear.

Study design
This is a single-arm, prospective, unblinded pilot study with 30 participants. It is designed to evaluate the feasibility and acceptability of integrating digital health technologies into early-phase cancer clinical trials.
What's involved
You would wear an actigraphy device for four weeks and complete a weekly 26-item questionnaire on a mobile app for four weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 4 weeks, indicating the duration of active participation.

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NCT07541365

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

Recruiting
NAAges 18+InterventionalDevice feasibility
Case Comprehensive Cancer Center
~30 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Wearable actigraphyElectronic Patient-Reported Outcomes (ePROs)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of integrating wearable actigraphy monitoring in early phase oncology clinical trials, as measured by proportion of participants
Measured over 4 weeks
+1 more outcome measured

Conditions

Cancer

Explore related trials

Malignant Neoplasm

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Joel Saltzman, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, Cleveland Clinic

Who to contact

Joel Saltzman, MD
[email protected]
440-312-4569
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility of integrating wearable actigraphy monitoring in early phase oncology clinical trials, as measured by proportion of participants4 weeks

    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.

  • Feasibility of integrating electronic patient-reported outcomes (ePROs) in early phase oncology clinical trials, , as measured by proportion of participants4 weeks

    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.