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)
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 (BioWEAR)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks, 28 days
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether people with prostate cancer will use a smartwatch to track hot flashes caused by hormone-lowering treatment (ADT). It also compares watch data with daily hot flash surveys. Participants wear the watch for 4 weeks, press a button to log hot flashes, and answer surveys sent by text link.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be biologically male, age 18 or older, and have prostate cancer.
- Sign and date a consent form, agree to follow study steps, and be available for the whole study.
- Be receiving ADT, a treatment that lowers testosterone, and expect to continue it for at least 4 more weeks.
- Have records showing testosterone below 50 ng/dL after starting ADT, or a drop in PSA without a rise that meets the study’s limits. PSA is a blood marker used to track prostate cancer.
- Have hot flashes at least once a day that started after ADT began.
- Own a phone with Bluetooth 5 and agree to use cell data or Wi-Fi and download the Empatica Care app. The phone must be an iPhone 8 or newer with iOS 16.0 or newer, or an Android with version 12 or newer.
- Be able to read, speak, and understand English.
- Have an ECOG activity score of 0, 1, or 2: be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
Who can't join
- Your wrist measures less than 95 mm or more than 222 mm around.
- You have a known allergy to parts of the EmbracePlus smartwatch, especially a skin allergy to silicone.
- You had hot flashes before starting ADT, no matter how mild or brief.
- You currently have an illness with a fever above 38°C (100.4°F), or are being treated for an illness with fever.
- You cannot press the button on the side of the smartwatch.
- You are receiving an experimental prostate cancer treatment. Other standard prostate cancer treatments are allowed.
- Your prostate cancer is getting worse under the study’s rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
VA
- University of Virginia Health System · Charlottesville, VA 22908More trials in Charlottesville