整合4种方法来评估癌症患者的身体功能 (In4M):前性队列研究的协议
Gita Thanarajasingam1, Paul Kluetz2, Vishal Bhatnagar2
1Division of Hematology, Mayo Clinic, Rochester, Minnesota, USA thanarajasingam.gita@mayo.edu.
BMJ open
|January 10, 2024
概括
这项研究评估了用于测量化学治疗癌症患者身体功能的数字工具. 通过评估可穿戴设备和患者报告结果的数据,研究结果将为临床试验和瘤实践提供信息.
科学领域:
- 在瘤学瘤学.
- 数字健康数字健康
- 临床试验 临床试验
背景情况:
- 准确的身体功能评估对于了解癌症和治疗影响至关重要.
- 数字健康技术为测量患者症状和功能提供了新的方法.
- 各种评估类型的纵向测量特征需要进行临床决策的表征.
研究的目的:
- 描述癌症患者身体功能评估的纵向测量特性.
- 评估多式联络数据收集的可行性和患者体验.
- 在癌症临床试验和实践中为监管和临床决策提供信息.
主要方法:
- 招募200名乳腺癌或淋巴瘤患者接受化疗的前性研究.
- 使用临床医生报告的结果,患者报告的结果 (PROs) 和可穿戴传感器进行纵向的身体功能评估.
- 通过以患者为中心的平台进行数据聚合,并进行9个月的跟踪.
主要成果:
- 数据分析侧重于身体功能评估的可变性,敏感性和有意义的变化.
- 评估身体功能测量和关键临床结果之间的关系.
- 评估数据收集方法的可行性,可用性和可接受性.
结论:
- 在癌症患者中,使用数字健康工具进行多模式数据收集是可行的.
- 了解身体功能评估的测量特征对于瘤学研究和实践至关重要.
- 以患者为中心的数据聚合平台和可穿戴传感器显示出对现实世界瘤学应用的希望.
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