Use of a smartwatch to track hot flashes in men receiving androgen deprivation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will receive an EmbracePlus smartwatch, a brief in-person orientation at the University of Virginia, and a smartphone app to sync biometric data. They will wear the watch continuously for four weeks, press a button on the watch at the start and end of each hot flash, and complete daily electronic surveys about their symptoms. Biometric data will be transmitted via the app to the Empatica cloud for the research team to compare with participant survey logs. Devices and charging equipment must be returned to the study team at the end of the monitoring period.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Virginia Health System
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Michael Devitt, MD — University of Virginia
• Study coordinator: Ana Doder
• Email: Cus9jd@uvahealth.org
• Phone: 434-421-5577

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.