This is a prospective, randomized, non-pharmacologic interventional trial evaluating the effectiveness of the Embr Wave wearable thermal device in reducing hot flash burden in men with prostate cancer receiving androgen deprivation therapy (ADT). Participants will be randomized 1:1 to immediate (12 weeks) versus delayed (after 6 weeks) use of the Embr Wave device. The study aims to determine whether the device reduces vasomotor symptoms using a number of patient-reported outcomes
This is a randomized, supportive care trial in which men with prostate cancer on ADT and experiencing bothersome hot flashes will be assigned to either immediate use of the Embr Wave device for 12 weeks or delayed use (usual care for 6 weeks, then device for 6 weeks). The Embr Wave is a commercially available wearable device that provides a cooling sensation and is being tested for its ability to reduce hot flash severity and improve quality of life. Participants will be enrolled across the DF/HCC consortium and collaborative sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
A wearable thermal device that provides a cooling sensation on the wrist. The device is commercially available but not specifically approved for hot flashes in men with prostate cancer.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGHot Flash Related Daily Interference Scale (HFRDIS) Score
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed 6 weeks after randomization
HFRDIS Score [week 12]
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed at 12 weeks after randomization
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).
Time frame: Assessed at 6 weeks and 12 weeks after randomization
PROMIS Sleep-Related Impairment Score
PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).
Time frame: Assessed at 6 weeks and 12 weeks after randomization
HFRDIS Score Change from Baseline to Week 6
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed at baseline and 6 weeks after randomization
HFRDIS Score Change from Week 6 to Week 12
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed at 6 weeks and 12 weeks after randomization
PROMIS Sleep Disturbance Score Change from Baseline to Week 6
PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).
Time frame: Assessed at baseline and 6 weeks after randomization
PROMIS Sleep Disturbance Score Change from Weeek 6 to Week 12
PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).
Time frame: Assessed at 6 and 12 weeks after randomization
PROMIS Sleep-Related Impairment Score Change from Baseline to Week 6
PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).
Time frame: Assessed at baseline and 6 weeks after randomization
PROMIS Sleep-Related Impairment Score Change from Week 6 to Week 12
PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).
Time frame: Assessed at 6 and 12 weeks after randomization
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