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

August 31, 2026 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

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

Study Locations

United States
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Levine Cancer Institute

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

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 14
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).	Day 14

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

Atrium Health Levine Cancer Institute

Investigators

Principal Investigator: Dori Beeler, PhD, Wake Forest University Health Sciences

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)

October 4, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria