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多中心、开放标签、随机对照研究,以测试电子患者报告结局监测在不可切除的晚期癌症或转移性/复发性实体瘤患者中的效用。

Multicenter, open-label, randomized, controlled study to test the utility of electronic patient-reported outcome monitoring in patients with unresectable advanced cancers or metastatic/recurrent solid tumors.

作者信息

Taira Naruto, Kiyota Naomi, Kikawa Yuichiro, Ichihara Eiki, Kato Kyoko, Kubota Kaoru, Tateishi Ryosuke, Nakata Akinobu, Nakamura Keiichiro, Narita Yukiya, Hotta Katsuyuki, Iwata Hiroji, Gemma Akihiko, Shimozuma Kojiro, Muro Kei, Iwamoto Tetsuya, Takumoto Yuki, Shiroiwa Takeru, Fukuda Takashi, Yamaguchi Takuhiro, Hagiwara Yasuhiro, Minami Hironobu

机构信息

Department of Breast and Thyroid Surgery, Kawasaki Medical School, 577 Matsushima, Kurashiki City, Okayama, 701-0192, Japan.

Department of Medical Oncology and Hematology, Cancer Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo, 650-0017, Japan.

出版信息

Jpn J Clin Oncol. 2025 Apr 26;55(5):547-555. doi: 10.1093/jjco/hyaf033.

DOI:10.1093/jjco/hyaf033
PMID:39987488
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12034027/
Abstract

Electronic patient-reported outcome (ePRO) monitoring for patients undergoing cancer chemotherapy may provide qualified and early detection of adverse events or disease-related symptoms, leading to improved patient care. The aim of this study is to examine whether addition of ePRO monitoring to routine medical care contributes to improved overall survival and quality of life of cancer patients undergoing chemotherapy. Patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic chemotherapy will be randomized to an ePRO monitoring group and a usual care group. The ePRO group will conduct weekly symptom monitoring using an electronic device after study enrollment until the end of the study. Monitoring results will be returned to medical personnel and used as information for patient care. The primary endpoints are overall survival and health related quality of life. The initial target sample size for the study was 1500 patients. However, due to delays in enrollment, the target was readjusted to 500 patients. Enrollment has been completed, and the study is now in the follow-up phase.

摘要

对接受癌症化疗的患者进行电子患者报告结局(ePRO)监测,可能有助于对不良事件或疾病相关症状进行有效且早期的检测,从而改善患者护理。本研究的目的是检验在常规医疗护理中增加ePRO监测是否有助于提高接受化疗的癌症患者的总生存期和生活质量。患有不可切除的晚期癌症或接受全身化疗的转移性/复发性实体瘤患者将被随机分为ePRO监测组和常规护理组。ePRO组将在研究入组后使用电子设备每周进行症状监测,直至研究结束。监测结果将反馈给医务人员,并用作患者护理的信息。主要终点是总生存期和健康相关生活质量。该研究最初的目标样本量为1500名患者。然而,由于入组延迟,目标调整为500名患者。入组已完成,该研究现处于随访阶段。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3d2/12034027/2ada7d03de59/hyaf033f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3d2/12034027/0f9155433d2d/hyaf033f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3d2/12034027/2ada7d03de59/hyaf033f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3d2/12034027/0f9155433d2d/hyaf033f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3d2/12034027/2ada7d03de59/hyaf033f2.jpg

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J Patient Rep Outcomes. 2023 Jun 5;7(1):54. doi: 10.1186/s41687-023-00578-8.
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Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types.最小有意义变化值在解读 EORTC QLQ-C30 时间变化评分中的作用:跨越涉及 9 种不同癌症类型的 21 项临床试验的综合研究
Eur J Cancer. 2023 Jul;188:171-182. doi: 10.1016/j.ejca.2023.04.027. Epub 2023 May 7.
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Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial.
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The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline.患者报告结局指标在癌症临床连续照护中的作用:ESMO临床实践指南
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Multiplicity Considerations in Clinical Trials.临床试验中的多重性考量
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