患者报告结果/指标计划试验 (PROMPT) - 息性辐射:前性观察性可行性研究的协议
Hiba Othman1, Breffni Hannon1, Zhihui Amy Liu2
1Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Annals of palliative medicine
|December 8, 2025
概括
这项研究评估了使用智能衫 (Hexoskin医疗系统) 和数字平台 (Zamplo) 来远程监测接受息性放射治疗的转移性癌症患者的可行性. 研究结果表明,这种方法可以改善与治疗相关的不良事件的检测和患者的福祉.
科学领域:
- 在瘤学瘤学.
- 数字健康数字健康
- 生物医学工程 生物医学工程
背景情况:
- 息性放射治疗 (RT) 对于治疗转移性癌症患者的症状和提高生活质量至关重要.
- 在及时识别与RT相关的症状和不良事件 (AE) 方面存在挑战,原因是依赖诊所访问和患者召回.
- 这项研究探讨了Hexoskin医疗系统 (HMS) 生物识别监测智能衫和Zamplo数字健康平台在息性RT患者中报告症状的整合.
研究的目的:
- 评估使用HMS智能衫和Zamplo平台对接受息性RT的转移性癌症患者远程监测的可行性.
- 评估远程监控技术在息护理环境中的可接受性和实用性.
- 为了确定与AE相关的潜在生物识别变量和患者幸福感的变化.
主要方法:
- PROMPT试验是一项前性观察性可行性研究,招募100名转移性癌症患者接受息性RT.
- 参与者使用HMS智能衫进行日常监测,并使用Zamplo平台报告患者报告的结果 (PRO) 和症状.
- 通过验证的问卷 (EORTC QLQ-C30,EuroQol 5D-5L,PCC-CA-6,PRO-CTCAE) 收集PRO,并通过临床查 (ESAS) 进行补充.
主要成果:
- 主要终点是在12个月内成功招募100名患者,并在RT后30天内报告2级+AE的频率.
- 分析将重点关注远程监测的可行性和生物识别数据,报告的症状和AE之间的相关性.
- 该研究的目的是确定在30天内发生2级或以上的AE的频率.
结论:
- HMS智能衫和Zamplo平台显示了改善检测和及时管理RT相关的AE的潜力.
- 这种远程监控方法可能有助于确定AE和福祉变化的关键生物识别指标.
- 该研究将确定HMS衫的可接受性和可行性,用于缓解癌症患者的远程监测.
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