Improving Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients

 描述（由申请方提供）：辅助内分泌治疗（AET）是用于预防激素受体阳性乳腺癌患者复发和降低乳腺癌相关死亡率的治疗的重要组成部分。研究报告了对AET的低依从率（38%至86%），并且在我们的初步工作中，65%的服用AET的乳腺癌患者报告了一种或多种非依从服药行为（例如，漏服、忘记、调整剂量）。症状（例如，与AET相关的关节痛、血管炎症状）与不依从和早期停止治疗密切相关。由于症状导致的AET依从性差可能会影响AET的有效性。在拟议的随机临床试验中，400名正在服用AET治疗乳腺癌的妇女将被随机分配到两种条件之一：1）用于改善依从性和症状管理的自我管理干预，或2）一般健康教育控制条件。自我管理干预整合了三个关键的基于理论的策略，以提高对AET的依从性：管理症状的应对技能培训（例如，关节痛、血管炎症状）、改善药物依从性的行为策略以及症状和药物教育。该干预措施解决了女性正在经历的特定症状，旨在满足不遵守AET的高风险女性的需求（例如，社会经济地位低，识字率低）。自我管理干预由护士通过电话管理，并结合使用电话，干预工作簿与录音材料，以及基于电话会话期间交换的信息和从无线智能药瓶获得的实时依从性数据的定制交互式语音消息。随机分配到对照组的妇女将接受由护士通过 电话.这项研究将在杜克癌症研究所乳腺诊所和社区医院进行，这些医院是杜克癌症网络的成员，这将允许妇女在医疗中心以外接受治疗，并增加研究结果在各种环境中的普遍性。将在研究入组后18个月内使用提供实时依从性数据的无线智能药瓶评估AET依从性。将在基线和3、6、12和18个月时获得患者报告的结局指标，评估症状、AET的必要性、AET担忧和自我效能。为了增加以后实施自我管理干预措施的可能性，将对干预措施的成本效益进行评估。

 DESCRIPTION (provided by applicant): Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in our preliminary work, 65% of breast cancer patients taking AET reported one or more non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly related to non-adherence and early discontinuation of treatment. Poor adherence to AET due to symptoms may compromise the effectiveness of AET. In the proposed randomized clinical trial, 400 women who are taking AET for breast cancer will be randomly assigned to one of two conditions: 1) a self- management intervention for improving adherence and symptom management, or 2) a general health education control condition. The self-management intervention integrates three key theory-based strategies for improving adherence to AET: coping skills training for managing symptoms (e.g., arthralgia, vasomotor symptoms), behavioral strategies for improving medication adherence, and symptom and medication education. The intervention addresses the specific symptoms a woman is experiencing and is designed to meet the needs of women who are at high risk for non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management intervention is administered by a nurse via the telephone, and combines the use of phone calls, an intervention workbook with audio-recorded materials, and tailored interactive voice messaging based on information exchanged during phone sessions and real-time adherence data obtained from wireless smart medication bottles. Women randomly assigned to the control condition will receive a general health education intervention that is delivered by a nurse via the telephone. This study will take place in the Duke Cancer Institute breast clinic and in community hospitals that are members of the Duke Cancer Network, which will allow access to women receiving care outside the medical center setting and increase generalizability of findings to a variety of settings. Adherence to AET will be assessed over the 18 month period following study enrollment using wireless smart medication bottles that provide real-time adherence data. Patient-reported outcome measures assessing symptoms, perceived necessity of AET, concerns about AET, and self-efficacy will be obtained at baseline and 3, 6, 12, and 18 months. To increase the likelihood of later implementation of the self-management intervention, the cost effectiveness of the intervention will be evaluated.