WATD and Cancer-Related Fatigue: A Study For Patients Undergoing Anti-Cancer Treatment

Last updated: January 6, 2026
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Pancreatic Cancer

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT06291324
IRB00103472
NCI-2024-06147
LCI-SUPP-CRF-WATD-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the feasibility of using a commercial WATD (Wearable Activity Tracker Device) to collect HRV (Heart Rate Variability) data from pancreatic and breast cancer patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent and HIPAA authorization for release of personal healthinformation

  • Patients pancreatic or invasive breast cancer per enrolling investigator who isplanning on or has started anti-cancer treatment. Note: Patients with cancer who arenot planning to receive anti-cancer treatment are not eligible for studyparticipation

  • Patients with any severity of self-reported fatigue per enrolling investigator

  • Age ≥ 18 years at the time of consent

  • Ability to read and understand the English language

  • As determined by the enrolling investigator, the ability of the participant tounderstand and comply with study procedures (i.e., completing questionnaires anddevice return) for the entire length of the study

Exclusion

Exclusion Criteria:

  • Any documented, clinically significant cardiac-related abnormality per enrollinginvestigator that could compromise the outcome of the study. NOTE: The heart ratedata collected using the WATD will not be used for patient care.

  • Other factors or conditions, per investigator discretion, for which participation inthe study would not be in the patient's best interest or could interfere with studyassessment results or preclude study completion

  • No internet, Wi-Fi access or email account

  • No access to a smartphone or mobile device

Study Design

Total Participants: 46
Study Start date:
October 04, 2024
Estimated Completion Date:
June 30, 2027

Study Description

This feasibility study is designed to evaluate the collection of longitudinal HRV (Heart Rate Variability) data and assess acceptability of the device among adult cancer patients in the research setting. Over the course of the four-week study, participants will be asked to provide experiential diaries detailing adherence to and acceptability of the WATD (Wearable Activity Tracker Device) and conduct PRO (Patient Reported Outcome) measures at week two and week four (end of study). During the final research visit at week four, subjects will return the WATD and will complete the acceptability survey. Each week of the four-week study, the WATD data and experiential diaries will be downloaded for analysis.

Connect with a study center

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

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