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

August 3, 2026 updated by: Case Comprehensive Cancer Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In oncology, clinicians and researchers look at a person's clinical condition and functional status to understand how cancer and its treatment affect them. They use standardized rating scales to measure side effects from the disease or treatment. These scales grade how severe symptoms are based on factors such as the need for medical care, hospital stays, and whether a person can carry out daily activities.

Standard grading systems are commonly used in oncology to measure treatment- and disease-related side effects. These systems assign levels of severity based on clinical criteria, such as whether a person needs medical treatment, hospitalization, or has trouble with daily activities. These methods work well for measuring objective side effects, such as low blood cell counts or high liver enzyme levels. However, they are less accurate for symptoms that depend on a person's personal experience, such as fatigue, pain, or general discomfort. In these cases, there can be a gap between what people feel and what clinicians record. Because these symptoms depend on individual perception, they may be underreported or remembered inaccurately, which can make it harder for clinician reports to fully capture the person's symptom burden.

Most clinical trials, including large phase III randomized studies, use functional assessment scales to estimate how active participants are and how well they can tolerate treatment. Common tools include the Karnofsky Performance Status (KPS) and the Eastern Cooperative Oncology Group (ECOG) Performance Status. These scales are widely used in both research and clinical care to estimate prognosis, measure functional ability, and decide whether people are eligible for clinical trials. Although these scales are generally consistent, they do not always match closely with patient-reported outcomes or quality-of-life measures. Agreement between clinicians is usually good when people are grouped into broad categories (such as ECOG 0-2 versus 3-4). However, reliability decreases when clinicians try to distinguish between more specific categories, such as ECOG 0, 1, or 2.

Because of these limitations in measuring treatment tolerability, data often show differences in how well people tolerate treatment. This highlights the need for more objective and person-centered ways to measure functional status and symptoms. Wearable activity monitors may help address this issue by collecting continuous, real-time data about a person's physical activity and physiology. These devices may provide a clearer picture of how a person's function changes during treatment. When combined with electronic patient-reported outcomes (ePROs), wearable technology could improve symptom monitoring, help classify people more accurately, and support better treatment decisions in early-phase oncology trials.

Although earlier studies have shown that wearable devices can be used to monitor functional status in people with advanced gastrointestinal and lung cancers, their use in early-phase clinical trials is still limited. This study aims to address that gap by evaluating digital monitoring across several early-phase clinical trials, focusing on whether the approach is feasible rather than on disease-specific outcomes. By combining wearable activity data with ePROs, we hope to improve early detection of treatment-related side effects, refine dose-limiting toxicity (DLT) assessments, and support more accurate estimation of the maximum tolerated dose (MTD). Ultimately, this approach may help improve person-centered decision-making in early cancer drug development and guide future studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Joel Saltzman, MD
  • Phone Number: 440-312-4569
  • Email: saltzmj@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
        • Principal Investigator:
          • Joel Saltzman, MD
        • Contact:
          • Joel Saltzman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: 4 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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in clinician-reported and participant-reported symptoms, as measured by the ePRO-CTCAE
Time Frame: 4 weeks
Symptoms will be measured by the ePRO-CTCAE questionnaire (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) tailored to participants in early phase oncology clinical trials. The ePRO-CTCAE has 26 questions regarding the presence of various symptoms answered on a 5-point Likert scale. Each question ask participants to rank the symptoms for severity from 0 (None) to 5 (Very severe), presence from 0 (Not at all) to 5 (Very much), and frequency from 0 (Never) to 5 (Almost constantly). Higher scores indicate greater symptoms.
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.
Time Frame: 4 weeks
Difference in time (in days) from study enrollment to first occurrence of a Grade ≥1 adverse event, as based on clinician-reported CTCAE versus weekly ePRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) tailored to participants in early phase oncology clinical trials. The ePRO-CTCAE has 26 questions regarding the presence of various symptoms answered on a 5-point Likert scale. Each question ask participants to rank the symptoms for severity from 0 (None) to 5 (Very severe), presence from 0 (Not at all) to 5 (Very much), and frequency from 0 (Never) to 5 (Almost constantly). Higher scores indicate greater symptoms.
4 weeks
Qualitative experience of the participants with respect to usability of the mobile app and wearable device during the study
Time Frame: 4 weeks
Qualitative experience will be measured through exit interviews at the end of study participation and will be thematically analyzed. Interviews are semi-structured and ask questions regarding overall experience, wearable device use, app/ePRO use, adherence and engagement, perceptions of monitoring, perceived value, and suggestions for improvement.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joel Saltzman, MD, Case Comprehensive Cancer Center, Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CASE14Z25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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