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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embr thermal device | Experimental | Use of the Embr thermal device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embr thermal device | Device | Participants use the Embr thermal device for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Embr thermal device usage, average number of minutes per day per participant | Number of minutes logged with the Embr device. | Weeks 0 to 4 |
| Embr thermal device usage, average number of sessions per day per participant | Number of sessions logged with the Embr device. | Weeks 0 to 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Vasomotor Symptom Survey | Self-report 10-question survey of hot flash and night sweat number, duration, interference, bothersome rating, and control of interference. Score range 0 to 86 with higher score indicating greater negative impact of vasomotor symptoms. | Week 0, 1, 2, 3, 4 |
| Temperature-related quality of life and symptoms, change in score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Morgans, MD, MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Embr Labs (Remote study site) | Boston | Massachusetts | 02129 | United States |
Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
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Beginning 6 months after publication
Upon appropriate data request
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Embr thermal device
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| 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). | 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). | 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. | Week 0, 2, 4 |
Self-report measure of temperature-related quality of life and symptoms. Scores range from 0 to 100 with higher scores indicating greater quality of life. |
| Week 0, 2, 4 |
| User acceptance | Self-report 8-question survey at end of study. | Week 4 |
| 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 |