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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Breast Cancer; Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06291324

NCI-2024-06147 (Other Identifier)

IRB00103472

LCI-SUPP-CRF-WATD-001 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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