研究动态
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一项随机试验,研究使用电子患者报告结果应用程序进行症状监测对接受辅助内分泌治疗的绝经后乳腺癌患者的健康相关生活质量的影响。

A randomized trial of the impact of symptom monitoring using an electronic patient-reported outcome app on health-related quality of life in postmenopausal breast cancer patients receiving adjuvant endocrine therapy.

发表日期:2024 May 26
作者: Hiromi Okuyama, Fuka Takada, Naruto Taira, Seigo Nakamura
来源: MEDICINE & SCIENCE IN SPORTS & EXERCISE

摘要:

电子患者报告结果 (ePRO) 监测对于癌症患者和医疗保健提供者来说是一种有用的沟通工具。在这项研究中,我们检查了使用 ePRO 应用程序进行症状监测对接受辅助内分泌治疗的绝经后乳腺癌患者的生活质量 (QoL) 的影响。研究中使用了免费应用程序“Welby My Carte ONC”。开始辅助内分泌治疗的乳腺癌患者以 1:1 的比例随机分配到 ePRO 监测组 (ONC) 和对照组。 ONC 小组通过该应用程序连续 3 个月每周报告从患者报告结果 - 不良事件通用术语标准 (PRO-CTCAE) 中提取的五种症状(失眠、关节疼痛、头痛、焦虑和潮热)。报告的症状已与医务人员分享。当报告出现严重症状时,这些人员会确定患者的健康状况并通过电话提供建议。主要终点是入组后 3 个月时通过乳腺癌治疗功能评估 (FACT-B) 测量的生活质量。使用协方差分析测试组间差异。该研究包括 125 名受试者,ONC 组平均年龄 64 岁 (n = 61),对照组平均年龄 63 岁 (n = 64)。在 ONC 组中,直到第 10 周,PRO-CTCAE 的缓解率约为 70% 或更高。项目缺失率为 0。ONC 组报告了更多与关节疼痛和失眠相关的症状。各组之间的 FACT-B 总分差异为 - 1.55(95% 置信区间:- 5.91, 2.81),表明没有显着差异。术后开始辅助内分泌治疗后早期使用 ePRO 进行症状监测并没有改善乳房的生活质量癌症患者。© 2024。作者获得日本乳腺癌协会独家许可。
Electronic patient-reported outcomes (ePRO) monitoring is a useful communication tool for cancer patients and healthcare providers. In this study, we examined the impact of symptom monitoring using an ePRO app on quality of life (QoL) in postmenopausal breast cancer patients receiving adjuvant endocrine therapy.The free app "Welby My Carte ONC" was used in the study. Patients with breast cancer starting adjuvant endocrine therapy were randomly assigned in a 1:1 ratio to ePRO monitoring (ONC) and control groups. The ONC group reported five symptoms extracted from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) (insomnia, joint pain, headache, anxiety, and hot flashes) weekly for 3 months through the app. Reported symptoms were shared with medical personnel. When serious symptoms were reported, these personnel ascertained the patient's health status and provided advice over the phone. The primary endpoint was QoL measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 3 months from enrollment. Differences between groups were tested using analysis of covariance.The study included 125 subjects with mean age of 64 years in the ONC group (n = 61) and 63 years in the control group (n = 64). In the ONC group, the response rate to PRO-CTCAE was about 70% or higher until week 10. The item missing rate was 0. The ONC group reported more symptoms related to joint pain and insomnia. The difference in FACT-B total score between the groups was - 1.55 (95% confidence interval: - 5.91, 2.81), indicating no significant difference.Symptom monitoring using ePRO early after initiation of adjuvant endocrine therapy after surgery did not improve QoL of breast cancer patients.© 2024. The Author(s), under exclusive licence to The Japanese Breast Cancer Society.