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

年轻乳腺癌女性的主动症状监测和内分泌治疗的持续性

• 批准号: 10561700
• 负责人: Norah Lynn Henry
• 金额: $ 30.41万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-03 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10561700
• 关键词: Ablation; Address; Adherence; Advanced Malignant Neoplasm; Adverse event; Belief; Breast Cancer Risk Factor; Breast Cancer survivor; Cancer Research Network; Central America; Client satisfaction; Clinic Visits; Community Clinical Oncology Program; Data; Development; Disease; Disease Outcome; Disease-Free Survival; Drug Prescriptions; Early identification; Early treatment; Educational Intervention; Effectiveness; Electronics; Enrollment; Frequencies; Funding; Future; Goals; Gynecologic; Health; High Risk Woman; Internet; Intervention Studies; Knowledge; Latin America; Malignant Neoplasms; Menopausal Symptom; Methodology; Monitor; Musculoskeletal; Musculoskeletal Pain; Newly Diagnosed; Online Systems; Outcome Assessment; Ovarian; Ovarian Ablation; Patient Education; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Population; Premenopause; Quality of life; Questionnaires; Randomized; Recurrent Malignant Neoplasm; Reporting; Research; Resources; Risk; Self Efficacy; Series; Severities; Site; South America; Southwest Oncology Group; Symptoms; Tamoxifen; Toxic effect; Treatment-related toxicity; United States; Vasomotor; Woman; adjuvant endocrine therapy; breast cancer survival; cancer recurrence; cancer therapy; cohort; cost effective; effectiveness evaluation; experience; group intervention; health related quality of life; high risk; hormone receptor-positive; hormone therapy; improved; improved outcome; malignant breast neoplasm; mortality; multi-ethnic; oncology program; pain symptom; patient-clinician communication; premature; programs; psychological symptom; randomized trial; risk prediction model; symptom management; symptomatic improvement; treatment optimization; web-based tool; young woman

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.

项目摘要/摘要 用内分泌疗法与卵巢功能抑制（OFS）相结合5年的治疗可改善 与激素受体阳性乳腺癌的绝经前女性无病生存期相比 仅他莫昔芬。但是，有很高的早期治疗中断率，可以增加乳房 癌症复发和死亡率。大多数因过早治疗而导致治疗的患者 令人讨厌的毒性和生活质量降低（QOL）。因此，需要采取方法来改进 乳腺癌复发高风险的年轻妇女的症状管理。 使用患者报告的结果（PRO）改善了患者提供的沟通和患者满意度。在 高级癌症，基于网络的工具在诊所就诊之间进行主动症状监测可改善与健康有关的 QOL并增加了总体生存。但是，在早期癌症中，是否有任何数据支持 使用主动症状监测和专业人士影响疾病结果。 R01的目标是评估主动症状监测内分泌治疗的有效性 中断，并确定与这种管理方法相关的因素。我们假设 毒性的早期鉴定将改变患者的症状经历，从而增加 持续治疗。因此，我们将将主动症状监测方法应用于多样化， 新诊断为高风险，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社区肿瘤研究计划（NCORP）和 Swog癌症研究网络。接受内分泌治疗加上治疗的患者将是 注册并随机地将基于网络的症状评估以及患者与患者进行 仅教育。将解决以下特定目标：（1）研究主动症状的影响 通过内分泌疗法监测18个月的持久性，（2）检查主动症状的影响 监测早期乳房的绝经前妇女的关键治疗急性症状的严重程度 癌症和（3）开发一个风险预测模型，以识别患有ET不良风险增加的患者 可能受益于主动症状监测。通过这一系列目标，我们希望证明 主动症状监测对持续性的有效性，并在队列中内分泌治疗的耐受性 乳腺癌的年轻女性。此外，我们希望获得新知识，以提供重要的 初步数据以支持未来的介入研究，以内分泌的不持久性原因 治疗。通过内分泌治疗和减少治疗相关的毒性改善持久性将导致 改善了年轻乳腺癌幸存者的疾病结局和生活质量。