Actively Recruiting
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)
Led by University of Virginia · Updated on 2026-05-08
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if men with prostate cancer who experience hot flashes due to their Androgen Deprivation Therapy (ADT) will consistently use a smartwatch to track their health and log these symptoms. The study focuses on comparing data recorded by the smartwatch with daily surveys about the participants' hot flashes to better understand their experiences during ADT treatment. Participants will receive an EmbracePlus smartwatch and be trained on how to log hot flashes by pressing a button on the watch at the start and end of each event. They will be asked to wear the smartwatch continuously, except when charging, for 4 weeks. During this time, they will also receive up to four daily electronic surveys via text message to report the frequency and experience of their hot flashes. Throughout the study, biometric data will be collected via Bluetooth from the smartwatch to a smartphone app and then to a secure cloud server for monitoring. Participants will have periodic check-in calls and complete an end-of-study survey. The main outcomes measured include daily watch wear duration, days with logged hot flashes, and how closely the smartwatch logs match the daily surveys. Overall participation lasts 28 days.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Willingness to comply with all study procedures and available for the study duration
- Male (biologic sex), 18 years or older
- Diagnosis of prostate cancer
- Receiving active ADT treatment at enrollment, defined as medical or surgical intervention to lower serum testosterone below 50 ng/dL
- Evidence of castrate level testosterone by documented serum testosterone below 50 ng/dL or PSA decrease with no progression
- Expected duration of ADT of at least 4 weeks from enrollment
- Experiencing vasomotor symptoms (hot flashes) starting after ADT initiation, occurring at least once daily
- Own a compatible smartphone (iPhone 8 or higher with iOS 16.0+ or Android version 12 or higher) and agree to download the Empatica Care app
- Ability to read, speak, and understand English
- ECOG performance status of 0, 1, or 2
You will not qualify if you...
- Wrist circumference less than 95 mm or greater than 222 mm
- Known allergy to EmbracePlus smartwatch components, especially silicone skin allergy
- Vasomotor symptoms present before starting ADT
- Active fever over 38°C or receiving treatment for febrile illness
- Inability to press the smartwatch button
- Receiving any experimental therapy for prostate cancer (standard therapies allowed)
- Evidence of prostate cancer progression as defined by PCWG3 criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility confirmation and device orientation
Duration - 28 days
Participants wear a smartwatch continuously at home to log vasomotor symptom events and complete electronic surveys about symptom frequency and experiences.
Daily electronic surveys up to 4 times per day and continuous use of the smartwatch
Duration - 1 day
Participants complete a check-in phone call and an end of study survey to review their experience.
1 phone call and 1 electronic survey
Trial Site Locations
Total: 1 location
1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
A
Ana Doder
E
Emily Leytham
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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