Improving Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients

 描述(由申请人提供)：辅助内分泌治疗(AET)是激素受体阳性乳腺癌患者用于预防复发和降低乳腺癌相关死亡率的治疗的关键组成部分。研究报告AET的依从率较低(38%至86%)，在我们的初步工作中，65%的服用AET的乳腺癌患者报告了在过去一个月中一次或多次不依从性服药行为(例如，跳过剂量、忘记、调整剂量)。与AET相关的症状(如关节痛、血管舒缩症状)与不坚持和过早停止治疗密切相关。由于症状导致对AET的依从性差，可能会损害AET的有效性。在拟议的随机临床试验中，400名正在接受AET治疗乳腺癌的妇女将被随机分配到两种情况之一：1)自我管理干预以改善依从性和症状管理，或2)一般健康教育控制情况。自我管理干预结合了提高AET依从性的三个关键理论策略：管理症状(如关节痛、血管舒缩性症状)的应对技能培训，提高服药依从性的行为策略，以及症状和用药教育。该干预措施针对妇女正在经历的具体症状，旨在满足不遵守教育援助的高风险妇女的需要(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进行管理，并结合使用电话呼叫、带有音频记录材料的干预工作簿和基于在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一般健康教育干预，由护士通过 电话。这项研究将在杜克癌症研究所乳房诊所和杜克癌症网络成员的社区医院进行，这将使妇女能够在医疗中心之外接受治疗，并增加研究结果对各种环境的普适性。在研究登记后的18个月内，将使用提供实时依从性数据的无线智能药瓶对AET的依从性进行评估。患者报告的结果评估指标将在基线和3、6、12和18个月时获得，评估症状、感觉到AET的必要性、对AET的担忧和自我效能。为了增加以后实施自我管理干预的可能性，将对干预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.