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 thermal device as needed for management of hot flashes for 4 weeks. The primary outcome was thermal device usage (hours and sessions per day). Additional outcomes included the change in 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. The baseline mean ± SD HFRDIS score of 4.3 ± 2.0 indicated moderate hot flash interference in this population. During the study, participants used the thermal device (mean ± SD) 3.2 ± 2.5 hours/day and 7.6 ± 3.6 sessions/day. Most (67%) participants reported using the device 7 days and 7 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 < 0.001). 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 the impact of the thermal device on frequency and severity of hot flashes, sleep quality, fatigue, and overall quality of life.

中文翻译：

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新型可穿戴热装置用于治疗前列腺癌患者烦人的潮热的可行性

 背景

这项单臂前瞻性研究评估了一种新型腕戴式热装置的可行性，该装置可对手腕内部进行冷却，以治疗前列腺癌幸存者令人烦恼的潮热。

 方法

57 名受试者被招募，并被指示根据需要使用热装置来管理潮热，为期 4 周。主要结果是热设备的使用情况（每天的小时数和会话数）。其他结果包括潮热相关日常干扰量表 (HFRDIS，范围 0-10) 和患者报告结果测量信息系统睡眠障碍 4a (PROMIS SD T 分数，范围 0-100) 和睡眠相关障碍 8a (PROMIS) 的变化SRI T 分数，范围 0–100）。研究程序于 2021 年 5 月至 12 月在美国远程进行。

 结果

44 名参与者完成了研究，其中 39 名参与者拥有可检索的使用数据。癌症诊断后的平均±标准差年龄为 67±6 岁和 5±5 岁。基线平均值 ± SD HFRDIS 评分为 4.3 ± 2.0，表明该人群存在中度潮热干扰。在研究期间，参与者使用热设备（平均值±标准差）3.2±2.5小时/天和7.6±3.6次/天。大多数 (67%) 参与者表示每周使用该设​​备 7 天 7 夜。在第 4 周时，观察到 HFRDIS（平均值 ± SE 变化：-1.1 ± 0.3）、PROMIS SD (-6.0 ± 1.0) 和 PROMIS SRI (-5.5 ± 1.2) 评分较基线有统计学上的显着改善（所有 p < 0.001）。大多数（69%）的参与者表示，保暖设备可以有效帮助他们控制潮热。没有不良事件的报告。

 结论

结果支持使用热装置来治疗前列腺癌幸存者烦人的潮热的可行性。未来的随机对照研究有必要评估热装置对潮热频率和严重程度、睡眠质量、疲劳和整体生活质量的影响。