Division of Breast Surgical Oncology, Department of Surgery, Showa University School of Medicine, Tokyo, Japan.
Division of Cancer Genetics and Pharmacotherapy, Department of Clinical Pharmacy, Showa University School of Pharmacy, Tokyo, Japan.
Breast Cancer. 2024 Sep;31(5):787-797. doi: 10.1007/s12282-024-01592-4. Epub 2024 May 26.
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.
电子患者报告结局（ePRO）监测是癌症患者和医疗保健提供者的一种有用的沟通工具。在这项研究中，我们研究了使用 ePRO 应用程序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。
研究中使用了免费的应用程序“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（ONC）和对照组。ONC 组通过应用程序每周报告从患者报告的结局-常见不良事件术语标准（PRO-CTCAE）中提取的五个症状（失眠、关节痛、头痛、焦虑和热潮红），持续 3 个月。报告的症状与医务人员共享。当出现严重症状时，这些人员会确定患者的健康状况并通过电话提供建议。主要终点是从入组开始 3 个月时通过癌症治疗功能评估-乳房（FACT-B）测量的 QoL。使用协方差分析检验组间差异。
该研究纳入了 125 名平均年龄为 64 岁的 ONC 组（n=61）和 63 岁的对照组（n=64）患者。在 ONC 组中，直到第 10 周，PRO-CTCAE 的应答率约为 70%或更高。项目缺失率为 0。ONC 组报告了更多与关节痛和失眠相关的症状。两组间 FACT-B 总分的差异为-1.55（95%置信区间：-5.91，2.81），表明无显著差异。
手术后辅助内分泌治疗早期使用 ePRO 监测症状并未改善乳腺癌患者的 QoL。
