Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VMS logging | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Smartwatch for VMS Logging
- description
- Participants will be asked to wear a smartwatch during daily life and log VMS events by pressing a designated button on a smartwatch device. Participants will be asked to wear the watch for the duration of the study. Participants will receive daily electronic (Ecological Momentary Assessments) EMAs from the UVA Qualtrics platform via text message link. EMAs are used to record VMS frequency and subjective experiences.
- interventionNames
- Behavioral: VMS logging
Primary outcomes (3)
- measure
- Duration of wear per day
- timeFrame
- 28 days
- description
- For each participant, we will calculate the duration of device wear for each day using the real-time data recorded by the device and estimate the mean daily duration.
- measure
- Percent of days with self-reported time marked vasomotor events
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available