Health TrialsbyHealthPanel

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

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Wearable Actigraphy + ePROsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks
2

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.

Time frame
4 weeks

Secondary outcomes

1

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

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.

Time frame
4 weeks
2

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.

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.

Time frame
4 weeks
3

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

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.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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Case Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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