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CompletedNCT06291324ClinicalTrials.gov record

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

Pancreatic Cancer · Breast Cancer

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
33 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Written informed consent and HIPAA authorization for release of personal health information
  • Patients pancreatic or invasive breast cancer per enrolling investigator who is planning on or has started anti-cancer treatment. Note: Patients with cancer who are not planning to receive anti-cancer treatment are not eligible for study participation
  • 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 to understand and comply with study procedures (i.e., completing questionnaires and device return) for the entire length of the study

Exclusion Criteria:

  • Any documented, clinically significant cardiac-related abnormality per enrolling investigator that could compromise the outcome of the study. NOTE: The heart rate data collected using the WATD will not be used for patient care.
  • Other factors or conditions, per investigator discretion, for which participation in the study would not be in the patient's best interest or could interfere with study assessment results or preclude study completion
  • No internet, Wi-Fi access or email account
  • No access to a smartphone or mobile device

Study population

Patients ≥ 18 years of age who have any stage pancreatic or breast cancer per enrolling investigator and have self-reported fatigue

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Adherence and acceptability

Time frame: Day 14

Adherence is a binary variable and will be determined based on whether the participant uploads HRV data each morning at least 75% of the days during the 14-day trial. Acceptability is a binary variable, and it is based on participant's response to the question whether they find the Wearable Activity Tracker Device (WATD) easy to use in the acceptability survey.

Secondary measures

Theme

Time frame: Day 14

Themes are categories of consolidated meaning derived from qualitative data that concern acceptability and adherence to using the Wearable Activity Tracker Device (WATD). They are derived based on qualitative analysis of the Experiential Diary, Acceptability survey open-ended data, and lifestyle behavior data. Theme is a categorical variable.

Heart rate variability (HRV)

Time frame: Day 14

HRV is the variation in the time intervals between adjacent heartbeats. It is a continuous variable and is measured by the Wearable Activity Tracker Device (WATD).

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Levine Cancer InstituteCharlotte, North Carolina, United StatesStatus unknown

Study team and timeline

Lead sponsor
Wake Forest University Health Sciences
Study start
Oct 4, 2024 Actual
Primary completion
Aug 21, 2026 Actual
Study completion
Aug 23, 2026 Actual
First posted
Mar 4, 2024 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Wearable Activity Tracker Devices and Cancer-Related Fatigue: A Clinical Utility Pilot Study For Patients Undergoing Anti-Cancer Treatment

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026