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: 10337861
• 负责人: Norah Lynn Henry
• 金额: $ 44.51万
• 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/10337861
• 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; Enrollment; Frequencies; Funding; Future; Goals; Gynecologic; Health; High Risk Woman; Internet; Intervention Studies; Knowledge; Latin America; Lead; 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; 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; base; 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.

项目总结/摘要 内分泌治疗联合卵巢功能抑制（OFS）治疗5年改善 绝经前激素受体阳性乳腺癌妇女的无病生存率与 他莫昔芬单药然而，早期停药的比例很高，这可能会增加乳腺癌的发病率。 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，需要采取措施进行改进 乳腺癌复发高危年轻女性症状管理 患者报告结局（PRO）的使用改善了患者与提供者的沟通和患者满意度。在 晚期癌症，使用基于网络的工具在诊所就诊之间进行主动症状监测， QOL和增加总生存期。然而，在早期癌症中，如果有任何数据支持， 使用PRO进行主动症状监测以影响疾病结局。 本R 01的目的是评价主动症状监测对内分泌治疗的有效性 停药，并确定与从这种管理方法中获益相关的因素。我们假设 早期发现毒性将改变患者的症状体验，导致增加 坚持治疗。因此，我们将主动症状监测方法应用于多种， 新诊断为高风险、早期乳腺癌的绝经前妇女的多种族队列。我们 拟议的研究将利用NCI社区肿瘤学研究计划（NCORP）的资源， SWOG癌症研究网络开始接受内分泌治疗加OFS治疗的患者将 入组并随机分配至主动、基于网络的症状评估加患者教育组与 只有教育。具体目的如下：（1）研究活动性症状的影响 监测内分泌治疗18个月的持续性，（2）检查活动性症状的影响 监测绝经前早期乳腺癌女性的关键治疗后出现的症状的严重程度 癌症，以及（3）开发风险预测模型，以识别ET非持续性风险增加的患者， 可能会从积极的症状监测中受益。通过这一系列的目标，我们希望证明 一个队列中主动症状监测对内分泌治疗持续性和耐受性有效性 患乳腺癌的年轻女性。此外，我们希望获得新的知识，这将提供重要的 支持未来针对内分泌非持久性原因的干预性研究的初步数据 疗法提高内分泌治疗的持久性和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。