Using a wearable device to track fatigue in cancer patients
Wearable Activity Tracker Devices and Cancer-Related Fatigue: A Clinical Utility Pilot Study For Patients Undergoing Anti-Cancer Treatment
This study is testing whether a wearable device can help track fatigue levels in people with pancreatic and breast cancer who are receiving treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT06291324 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using a commercial Wearable Activity Tracker Device (WATD) to collect Heart Rate Variability (HRV) data from patients with pancreatic and breast cancer undergoing anti-cancer treatment. Over four weeks, participants will maintain experiential diaries to document their adherence to and acceptability of the device, while also completing Patient Reported Outcome measures at two intervals. The study will analyze the collected data to assess the device's effectiveness in monitoring fatigue levels in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pancreatic or invasive breast cancer who are planning to undergo anti-cancer treatment and report any level of fatigue.
Not a fit: Patients who are not planning to receive anti-cancer treatment or have significant cardiac abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into managing cancer-related fatigue through continuous monitoring.
How similar studies have performed: While the use of wearable devices in monitoring health is gaining traction, this specific approach to tracking fatigue in cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlotte, North Carolina
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Dori Beeler, PhD — Wake Forest University Health Sciences
- Study coordinator: Maggie Dzhanumova
- Email: margarita.dzhanumova@advocatehealth.org
- Phone: 704-754-3768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.