Feasibility of a novel wearable thermal device for management of bothersome hot flashes in patients with prostate cancer

Abstract

Abstract BACKGROUND This single-arm prospective study evaluated the feasibility of a novel wrist-worn thermal device that applies cooling to the inside of the wrist for management of bothersome hot flashes in prostate cancer survivors. METHODS 57 individuals were enrolled and instructed to use the device as needed for 4 weeks. The primary outcome was thermal device usage (hours and sessions per day). Additional outcomes included the change in patient reported Hot Flash Related Daily Interference Scale (HFRDIS, range 0–10) and Patient Reported Outcomes Measurement Information System Sleep Disturbance 4a (PROMIS SD T-score, range 0-100) and Sleep Related Impairment 8a (PROMIS SRI T-score, range 0-100). Study procedures were conducted remotely from May to Dec 2021 in the US. RESULTS 44 participants completed the study and 39 had retrievable usage data. The mean ± SD age was 67 ± 6 years and 5 ± 5 years since cancer diagnosis. Baseline scores indicated moderate hot flash interference (HFRDIS mean ± SD: 4.3 ± 2.0) and mild sleep disturbance (PROMIS SD: 56.4 ± 6.7). Mean ± SD use of the thermal device was 3.2 ± 2.5 hours/day and 7.6 ± 3.6 sessions/day. Most (67%) participants reported using the device 7 days/nights each week. Statistically significant improvements from baseline at Week 4 were observed for HFRDIS (mean ± SE change: -1.1 ± 0.3), PROMIS SD (-6.0 ± 1.0), and PROMIS SRI (-5.5 ± 1.2) scores (all p < .001). Improvements were also observed in subjective measures of hot flashes and night sweats. The majority (69%) of participants reported that the thermal device was effective at helping them manage hot flashes. No adverse events were reported. CONCLUSIONS Results support the feasibility of using the thermal device for management of bothersome hot flashes in prostate cancer survivors. Future randomized controlled studies are warranted to evaluate patient reported outcomes related to frequency and severity of hot flashes, sleep quality, fatigue, and overall quality of life.