改善CDK4/6抑制剂在乳腺癌中的坚持使用连接的定制治疗平台 (CONCURxP) 移动卫生干预:研究协议ECOG-ACRINEAQ221CDCD
Gelareh Sadigh1, Fenghai Duan2, Ilana F Gareen3
1Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA, United States of America.
Contemporary clinical trials
|November 20, 2025
概括
一项移动健康干预改善了乳腺癌患者对循环素依赖性激酶4/6抑制剂 (CDKI) 的坚持. 这个平台提供定制支持,提高治疗效率和患者体验.
科学领域:
- 在瘤学瘤学.
- 数字健康数字健康
- 患者的坚持 患者的坚持
背景情况:
- 循环素依赖性激酶4/6抑制剂 (CDKI) 增强激素受体阳性 (HR+),人体表皮生长因子受体2-阴性 (HER2-) 乳腺癌的存活率,当与内分泌疗法结合使用时.
- 诸如复杂的剂量表,副作用和高成本等挑战往往导致CDKI治疗的患者不坚持治疗.
研究的目的:
- 评估 CONNECTED CUstomized Treatment Platform (CONCURxP) 的有效性,这是一个移动健康干预措施,用于改善CDKI的遵守.
- 为了比较患者报告的结果,包括症状负担,生活质量和财务担忧,在CONCURxP和增强常规护理 (EUC) 组之间.
- 使用混合方法探索患者与CONCURxP干预的经验.
主要方法:
- 一个双臂随机对照试验 (EAQ221CD) 涉及390名乳腺癌患者新处方CDKI.
- CONCURxP部门使用智能袋 (Wisebag) 实时监控合规性,发送文本提醒,对合规性障碍进行调查,并建立一个网络门户. 对于错过或额外的剂量,向瘤学团队发送了警报.
- EUC部门提供了关于副作用管理的教育材料. 使用Wisebag测量了坚持,患者报告的结果在基线和12个月评估.
主要成果:
- 主要结果是通过Wisebag.bag测量CONCURxP和EUC臂之间的12个月CDKI坚持的比较.
- 二级结局包括比较患者报告的症状负担,生活质量,患者提供者沟通,自我有效性和12个月的财务担忧.
- 将采用混合方法来描述患者与CONCURxP干预的经验.
结论:
- CONCURxP的干预旨在提供可操作的见解,以改善CDKI的遵守.
- 该研究旨在提高HR+/HER2-乳腺癌患者的整体健康结果和患者体验.
- 预计这些研究结果将为癌症治疗坚持的数字健康策略的开发提供信息.
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