Active Symptom Monitoring and Endocrine Therapy Persistence in Young Women with Breast Cancer

项目摘要/摘要 内分泌治疗结合卵巢功能抑制(OFS)5年改善 激素受体阳性乳腺癌绝经前妇女的无病生存率与 单独使用他莫昔芬。然而，早期停止治疗的比率很高，这可能会增加乳房 癌症复发和死亡率。大多数过早停止治疗的患者是因为 令人烦恼的毒性和生活质量(QOL)下降。因此，需要采取措施加以改进 乳腺癌复发高危年轻女性的症状处理。 使用患者报告的结果(PRO)可以改善患者与提供者之间的沟通并提高患者满意度。在……里面 晚期癌症，通过基于网络的工具在两次就诊之间进行主动症状监测，改善与健康相关的 提高生活质量，提高总体存活率。然而，在早期癌症中，支持这一点的数据有限 与专业人员一起使用主动症状监测来影响疾病结局。 本R01的目的是评估内分泌治疗中主动症状监测的有效性。 停产，并确定与从这一管理方法中获益相关的因素。我们假设 及早识别毒性将改变患者的症状体验，导致 坚持不懈地接受治疗。因此，我们将把主动症状监测方法应用于不同的、 新诊断为高危早期乳腺癌的绝经前妇女的多民族队列。我们的 拟议的研究将利用NCI社区肿瘤学研究计划(NCORP)的资源和 SWOG癌症研究网络。开始接受内分泌治疗加OFS治疗的患者将是 登记并随机接受基于网络的主动式症状评估以及患者教育与患者 光是教育就行。将解决以下具体目标：(1)调查活动症状的影响 监测内分泌治疗持续18个月，(2)观察活动性症状的疗效 绝经前早期乳房患者急诊症状严重程度监测 癌症，以及(3)开发风险预测模型，以确定谁是ET非持续性风险增加的患者 很可能受益于主动的症状监测。通过这一系列目标，我们希望展示 主动症状监测对队列患者内分泌治疗持续性和耐受性的影响 患有乳腺癌的年轻女性。此外，我们希望获得新的知识，这将提供重要的 初步数据支持未来针对内分泌不持久原因的干预性研究 心理治疗。提高内分泌治疗的持久性并减少治疗相关毒性将导致 改善年轻乳腺癌幸存者的疾病结局和生活质量。

PROJECT SUMMARY/ABSTRACT Treatment with endocrine therapy in combination with ovarian function suppression (OFS) for 5 years improves disease-free survival in premenopausal women with hormone receptor positive breast cancer compared to tamoxifen alone. However, there is a high rate of early treatment discontinuation, which can increase breast cancer recurrence and mortality. Most patients who discontinue treatment prematurely do so because of bothersome toxicities and decreased quality of life (QOL). Therefore, approaches are needed to improve symptom management in young women at high risk of breast cancer recurrence. Use of patient reported outcomes (PRO) improves patient-provider communication and patient satisfaction. In advanced cancer, active symptom monitoring between clinic visits with a web-based tool improves health-related QOL and increases overall survival. However, in early stage cancer there are limited if any data to support the use of active symptom monitoring with PROs to impact disease outcomes. The objectives of this R01 are to evaluate the effectiveness of active symptom monitoring on endocrine therapy discontinuation, and to identify factors associated with benefit from this management approach. We hypothesize that early identification of toxicity will change the symptom experience of patients, leading to increased persistence with therapy. Therefore, we will apply the active symptom monitoring methodology to a diverse, multiethnic cohort of premenopausal women with newly diagnosed high risk, early stage breast cancer. Our proposed study will leverage the resources of the NCI Community Oncology Research Program (NCORP) and the SWOG Cancer Research Network. Patients initiating treatment with endocrine therapy plus OFS will be enrolled and randomized to proactive, web-based symptom assessment plus patient education versus patient education alone. The following Specific Aims will be addressed: (1) to investigate the impact of active symptom monitoring on 18-month persistence with endocrine therapy, (2) to examine the effect of active symptom monitoring on severity of key treatment-emergent symptoms in premenopausal women with early stage breast cancer, and (3) to develop a risk prediction model to identify patients at increased risk of ET nonpersistence who are likely to benefit from active symptom monitoring. Through this series of Aims we expect to demonstrate the effectiveness of active symptom monitoring on persistence with and tolerance of endocrine therapy in a cohort of young women with breast cancer. In addition, we expect to obtain new knowledge that will provide important preliminary data to support future interventional studies targeting reasons for nonpersistence with endocrine therapy. Improving persistence with endocrine therapy and reducing treatment-associated toxicity will lead to improved disease outcomes and quality of life for young breast cancer survivors.