This study is being conducted to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment.
The Embr thermal device is a smart device that is worn on the inside of the wrist. It is about the size of a smart watch. The Embr thermal device produces cooling or warming temperature sensations that make some people feel slightly cooler or warmer. This objective of this study is to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment. The study will take place over 4 weeks. The primary outcome is feasibility of the Embr thermal device in men with prostate cancer. Secondary outcomes include preliminary efficacy of the device, which will include the change in hot flash interference sleep measures (sleep impairment and fatigue). This is a remote study--all study assessments will be completed electronically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Participants use the Embr thermal device for 4 weeks
Embr Labs (Remote study site)
Boston, Massachusetts, United States
Embr thermal device usage, average number of minutes per day per participant
Number of minutes logged with the Embr device.
Time frame: Weeks 0 to 4
Embr thermal device usage, average number of sessions per day per participant
Number of sessions logged with the Embr device.
Time frame: Weeks 0 to 4
Hot Flash Related Daily Interference Scale (HFRDIS), change in score
The Hot Flash Related Daily Interference Scale is a 10-item self-report measure that assesses the interference on several aspects of functioning associated with hot flashes. This valid and reliable self-report measure is widely used in prostate cancer research. Scores range from 0 to 100, with higher scores indicating greater interference.
Time frame: Week 0, 2, 4
PROMIS Sleep Disturbance short form 4a, change in score
The PROMIS Sleep Disturbance SF 4a is a 4-item self report measure of perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
Time frame: Week 0, 2, 4
PROMIS Sleep-Related Impairment short form 8a, change in score
The PROMIS Sleep-Related Impairment SF 8a is an 8-item self reported measure of perceived alertness, sleepiness, and tiredness during usual waking hours. The 8 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 8 (good quality) to 40 (poor quality).
Time frame: Weeks 0, 2, 4
Epworth sleepiness scale, change in score
The Epworth Sleepiness Scale is a widely used measure of daytime sleepiness. Scores range from 0 to 24; scores of greater than 10 indicate excessive daytime sleepiness.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 0, 2, 4