NCT07535541

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 (Prostate 007)

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if patients with prostate cancer who have vasomotor symptoms, commonly called hot flashes, from their Androgen Deprivation Therapy (ADT) will consistently wear a smartwatch device to track their health data, log hot flashes on their smartwatch, and how these data compare with daily surveys about their hot flashes. Participants will be asked to wear the smartwatch for 4 weeks and to log their hot flashes on their smart watch pressing a button on the watch. Participants will be asked to complete surveys (sent through a text message link) to describe their experiences with hot flashes.

Detailed description

Participants in this study will be asked to log vasomotor symptoms events (VMS or hot flashes) via a smartwatch device and record VMS frequency and subjective experiences via daily electronic surveys. After a consent is signed and eligibility is confirmed, participants will receive an EmbracePlus (Empatica, Inc.) smartwatch, corresponding charging device, and manual. Participants will download the Empatica Care smartphone application. The study team will verify successful pairing of the EmbracePlus smartwatch to the participant's smart phone and the collection of biometric data. The study team will instruct participants on use of the device, including instructions on logging VMS events. This orientation will occur at the University of Virginia. The smartwatches and charging devices must be returned to the study team. Participants will then take the watch home and be asked to continuously wear their EmbracePlus smartwatch (with the exception of time needed to charge the device) for the duration of the study. Participants will be asked to log VMS event by pressing a designated button on the smartwatch device for one second, once at the beginning and once at the conclusion of an event. Data will be transmitted via Bluetooth connection from the EmbracePlus smartwatch to the Empatica Care smartphone application. Data will then be transferred from the app to the Empatica Cloud server, where the research team will access and monitor the data. The Empatica Health Monitoring Platform received initial FDA clearance in 2022. Participants will receive electronic EMAs from the UVA Qualtrics platform up to 4 times per day, for 28 days. Participants will receive a check-in call and an end of study survey.

Conditions

• Prostate Cancer
• Hot Flashes

Interventions

Type	Name	Description
BEHAVIORAL	VMS logging	Wearing of smartwatch and logging VMS

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States