Hot Flashes, Prostate Cancer
Conditions
Keywords
VMS, Hot flashes, ADT, Prostate Cancer, vasomotor symptoms, vasomotor symptom event, Smartwatch, Survey, EMA, androgen deprivation therapy
Brief summary
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.
Detailed description
Participants in this study will be asked to log vasomotor symptoms events (VMS or hot flashes) via a smartwatch device and record VMS frequency and subjective experiences via daily electronic surveys. After a consent is signed and eligibility is confirmed, participants will receive an EmbracePlus (Empatica, Inc.) smartwatch, corresponding charging device, and manual. Participants will download the Empatica Care smartphone application. The study team will verify successful pairing of the EmbracePlus smartwatch to the participant's smart phone and the collection of biometric data. The study team will instruct participants on use of the device, including instructions on logging VMS events. This orientation will occur at the University of Virginia. The smartwatches and charging devices must be returned to the study team. Participants will then take the watch home and be asked to continuously wear their EmbracePlus smartwatch (with the exception of time needed to charge the device) for the duration of the study. Participants will be asked to log VMS event by pressing a designated button on the smartwatch device for one second, once at the beginning and once at the conclusion of an event. Data will be transmitted via Bluetooth connection from the EmbracePlus smartwatch to the Empatica Care smartphone application. Data will then be transferred from the app to the Empatica Cloud server, where the research team will access and monitor the data. The Empatica Health Monitoring Platform received initial FDA clearance in 2022. Participants will receive electronic EMAs from the UVA Qualtrics platform up to 4 times per day, for 28 days. Participants will receive a check-in call and an end of study survey.
Interventions
BEHAVIORALVMS logging
Wearing of smartwatch and logging VMS
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single Group
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of wear per day | 28 days | 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 | 28 days | 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. | 28 days | Concordance between time marked vasomotor events and EMA reporting of vasomotor events during the corresponding time period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete the post-intervention visit | 28 days | Number of participants who complete the post-intervention visit |
| Post intervention survey | 28 days | Post intervention survey |
Countries
United States
Contacts
CONTACTAna Doder
CONTACTEmily Leytham
PRINCIPAL_INVESTIGATORMichael Devitt, MD
University of Virginia
Outcome results
None listed