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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male (biologic sex), aged ≥18 years of age

Diagnosis of prostate cancer

Disqualifiers

Wrist circumference less than 95 mm or greater than 222 mm

Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone

Presence of VMS prior to initiation of ADT, regardless of severity or duration

Active febrile illness (temperature >38°C) or on active treatment for febrile illness

Trial design

Treatments tested in this trial

  • VMS logging

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators