Smartwatch Technology for Hot Flashes in Prostate Cancer
(BioWEAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if prostate cancer patients experiencing hot flashes from hormone therapy can effectively use a smartwatch to log these episodes (VMS logging). Participants will wear the smartwatch for four weeks, recording hot flashes at the push of a button and completing daily surveys about their experiences. The trial seeks men actively undergoing hormone treatment for prostate cancer who have daily hot flashes and own a smartphone with Bluetooth 5 capability. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may enhance symptom tracking for future patients.
What prior data suggests that this smartwatch device is safe for tracking health data in prostate cancer patients?
Research has shown that using smartwatch technology to track hot flashes is generally safe for patients. Studies have found that similar devices, such as wrist-worn gadgets, are well-tolerated by people with prostate cancer. These devices help manage hot flashes without causing significant side effects. While the smartwatch in this study is used for tracking, not cooling, using wearables in this way has proven practical and safe. Participants in previous studies did not report major negative effects, suggesting that using a smartwatch to track symptoms is a safe option.12345
Why are researchers excited about this trial?
Researchers are excited about using smartwatch technology to manage hot flashes in prostate cancer patients because it offers a novel, non-invasive way to monitor symptoms in real time. Unlike traditional treatments that often rely on medications, this approach utilizes a smartwatch to log vasomotor symptoms (VMS) with a simple button press. This method not only allows for immediate data collection but also provides a more personalized understanding of each patient's experience, which could lead to more tailored and effective interventions in the future.
What evidence suggests that this smartwatch technology is effective for tracking hot flashes in prostate cancer patients?
This trial will evaluate the use of a smartwatch for VMS logging in managing hot flashes in prostate cancer patients. Participants will wear a smartwatch and log VMS events by pressing a designated button. Studies have shown that wearable technology, such as wrist-worn devices, can help manage hot flashes. Specifically, 69% of participants in one study found the device helpful in reducing symptoms. Another study demonstrated a noticeable decrease in the severity of hot flashes, suggesting that wearable technology may provide relief for patients experiencing hot flashes due to cancer treatments.13467
Who Is on the Research Team?
Michael Devitt, MD
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Orientation and Device Setup
Participants receive and set up the EmbracePlus smartwatch and are instructed on its use
Monitoring
Participants wear the smartwatch and log vasomotor symptoms for data collection
Follow-up
Participants complete a post-intervention survey and return the smartwatch
What Are the Treatments Tested in This Trial?
Interventions
- VMS logging
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Citations
Efficacy of Novel Wrist Cooling Device in Cancer Treatment ...
Univariate analysis confirmed significant reduction in hot flash severity (P < 0.01) after adjusting for age and underlying condition. No ...
Feasibility of a novel wrist-worn thermal device for ...
Feasibility of a novel wrist-worn thermal device for management of vasomotor symptoms in patients with prostate cancer. ; HFRDIS, mean [95% CI], 4.3 [3.7, 4.9]
ASCO 2022: Feasibility of a Novel Wrist-Worn Thermal ...
The majority (69%) of participants reported that the device was effective at helping them manage hot flashes. No adverse events were reported.
Feasibility of a novel wearable thermal device for ... - PMC - NIH
Results support the feasibility of using the thermal device for management of bothersome hot flashes in prostate cancer survivors. Future ...
5.
urologytimes.com
urologytimes.com/view/thermal-device-shows-feasibility-in-managing-prostate-cancer-related-hot-flashesThermal device shows feasibility in managing prostate ...
Regarding patient reported outcome measures, most participants (69%) indicated that the device was effective in helping them manage their hot ...
6.
cancertodaymag.org
cancertodaymag.org/cancer-talk/wearable-devices-help-monitor-patient-health-after-cancer-treatment/Wearable Devices Help Monitor Patient Health After Cancer ...
Researchers evaluate whether devices that track health metrics like daily steps and heart rate can help predict clinical outcomes.
Management of vasomotor symptoms in cancer patients
Many cancer treatments can lead to reduced levels of sex hormones, which in turn may cause vasomotor symptoms (VMS) such as hot flashes.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.