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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
VMS logging
BehavioralWearing of smartwatch and logging VMS
Treatment groups
Trial outcomes
Primary outcomes
Duration of wear per day
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.
Percent of days with self-reported time marked vasomotor events
Percent of days with self-reported time marked vasomotor events, using the real-time marked vasomotor events from the device.
Concordance between time marked vasomotor events and events described through EMAs.
Concordance between time marked vasomotor events and EMA reporting of vasomotor events during the corresponding time period.
Secondary outcomes
Number of participants who complete the post-intervention visit
Number of participants who complete the post-intervention visit
Post intervention survey
Post intervention survey
Sponsors and contacts
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