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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartwatch for VMS Logging | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VMS logging | Behavioral | Wearing of smartwatch and logging VMS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| 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. | 28 days |
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete the post-intervention visit | Number of participants who complete the post-intervention visit | 28 days |
| Post intervention survey | Post intervention survey |
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Inclusion Criteria:
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
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
Evidence of castrate level testosterone by either of the following:
Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment
Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day
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.
Ability to read, speak, and understand English
ECOG performance status of 0, 1, or 2
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Doder | Contact | 434-421-5577 | Cus9jd@uvahealth.org | |
| Emily Leytham | Contact | EL5MF@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Devitt, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Recruiting | Charlottesville | Virginia | 22908 | United States |
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Single Group
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| 28 days |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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