Use of a smartwatch to track hot flashes in men receiving androgen deprivation therapy
A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (BioWEAR)
This project will try using a smartwatch to record hot flashes and other health signals in men with prostate cancer on androgen deprivation therapy and compare those records with daily survey reports.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07535541 on ClinicalTrials.gov |
What this trial studies
Participants will receive an EmbracePlus smartwatch, a brief in-person orientation at the University of Virginia, and a smartphone app to sync biometric data. They will wear the watch continuously for four weeks, press a button on the watch at the start and end of each hot flash, and complete daily electronic surveys about their symptoms. Biometric data will be transmitted via the app to the Empatica cloud for the research team to compare with participant survey logs. Devices and charging equipment must be returned to the study team at the end of the monitoring period.
Who should consider this trial
Good fit: Men aged 18 or older with prostate cancer who are currently on ADT, have evidence of castrate-level testosterone, experience vasomotor symptoms, and can use a compatible smartphone and wear a smartwatch for four weeks.
Not a fit: Patients who do not have hot flashes, are not on ADT, or cannot or will not wear a smartwatch or use a smartphone are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, this could provide patients and clinicians a more objective, continuous way to track hot flash frequency and severity between clinic visits.
How similar studies have performed: Wearable devices have shown promising results for detecting hot flashes in women and other groups, but using this specific smartwatch approach in men on ADT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male (biologic sex), aged ≥18 years of age 4. Diagnosis of prostate cancer 5. Must be receiving active treatment with ADT at the time of enrollment a. ADT is defined as any medical or surgical intervention intended to lower the serum testosterone to \<50 mg/dL for the purpose of treating prostate cancer 6. Evidence of castrate level testosterone by either of the following: 1. A documented serum testosterone level of \<50 ng/dL at any time point since initiation of ADT or 2. A documented decrease in PSA following initiation of ADT and no evidence of PSA progression per PCWG3 criteria (PSA progression defined as a rise in PSA of ≥25% from PSA nadir and absolute increase of ≥1 ng/mL confirmed by a second measurement at least 3 weeks later) 7. Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment 8. Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day 9. Own a smartphone with Bluetooth 5 compatibility and be willing to use cellular data and/or Wi-Fi on their smartphone. Participants must agree to download the Empatica Care app on their smartphone. 1. iPhone 8 or higher with iOS 16.0 or higher 2. Android devices version 12, 12.1, 13, 14, 15, or higher 10. Ability to read, speak, and understand English 11. ECOG performance status of 0, 1, or 2 Exclusion Criteria: 1. Wrist circumference less than 95 mm or greater than 222 mm 2. Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone 3. Presence of VMS prior to initiation of ADT, regardless of severity or duration 4. Active febrile illness (temperature \>38°C) or on active treatment for febrile illness 5. Inability to press button on smart watch crown 6. Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted) 7. Evidence of progression of prostate cancer as defined by PCWG3 criteria
Where this trial is running
Charlottesville, Virginia
- University of Virginia Health System — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Michael Devitt, MD — University of Virginia
- Study coordinator: Ana Doder
- Email: Cus9jd@uvahealth.org
- Phone: 434-421-5577
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.