Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

描述（由申请人提供）：本申请的目的是改善癌症患者对口服化疗药物的依从性和症状的自我管理。目前市场上有40种口服药物，预计在3年内，25%的癌症治疗药物将以口服形式提供。因此，患者必须承担服用药物和自我管理相关副作用的责任。为了解决这些问题，我们与四个NCI综合癌症中心合作，他们将确定患者，因为他们是口服药物，介绍研究，那些接受将被随机分配到两个手臂之一。两组中的所有患者将接受8次每周一次的依从性和症状严重程度评估。此外，实验组中的受试者将在最初4周收到针对其剂量定制的脚本的每日提醒电话。对于报告的高于阈值的症状，将参考症状管理指南（SMG）以帮助自我管理。一个独特的功能是评估，提醒和症状管理策略将通过交互式语音应答系统（IVR）提供。该系统已在先前的试验和依从性的试点研究中进行了测试;它收到了患者的高满意度。测试以下结果：在4周时，实验组将具有更高水平的自我报告的依从性和症状管理，并且这些差异将在8周和12周时持续。此外，实验组在第4周、第8周和第12周时报告的过度依从率和依从性不足率均较低。探索性目的是评估患者和治疗变量对依从性和症状管理的调节作用。最后一个探索性的目的是评估一个重要的，但迄今为止尚未测试的问题：什么是依从性和患者的症状管理之间的关系？这项研究是由过去的试验和坚持口服药物和症状管理的大型试点研究指导的。患者报告的依从性根据药丸计数和患者记录中的脚本进行验证。每日提醒包括一个问题，以确定是否改变剂量。如果发生这种情况，每个研究中心的工作人员将监测访视和电话，以便在发生任何变化时立即停止提醒或调整剂量。所有管理症状的策略都是基于证据的，并通过该团队的早期工作进行了测试。达到紧急级别的症状被传达给每个站点的工作人员。该试验通过一个项目网站进行协调。这项试验的影响是，它测试了一个简短的有针对性的提醒系统，以模拟治疗开始时的依从性。它伴随着以患者为中心的症状管理策略。该系统被嵌入到肿瘤中心;它可以潜在地改变口服化疗治疗，同时确保患者的安全。

DESCRIPTION (provided by applicant): The goals of this application are to improve adherence to oral chemotherapeutic medications and self- management of symptoms among cancer patients. Forty oral agents currently are on the market with projections that in 3 years 25% of the cancer treatment agents will be delivered in oral form. As a result, patients must assume responsibility for taking medications and self-management of associated side effects. To address these issues we collaborate with four NCI Comprehensive Cancer Centers who will identify patients as they are prescribed oral agents, present the study, and those accepting will be randomized to one of two arms. All patients in both arms will receive 8 weekly assessments of adherence and symptom severity. In addition, those in the experimental arm will receive daily reminder calls for the initial 4 weeks of their scripts tailored to their dose. For symptoms reported above threshold they will be referred to a symptom management guide (SMG) to assist with self-management. A unique feature is that assessments, reminders, and symptom management strategies will be delivered by an Interactive Voice Response system (IVR). This system has been tested in a previous trial and in a pilot study of adherence; it received high satisfaction ratings from patients. The following outcomes are tested: at 4 weeks the experimental arm will have higher levels of self-reported adherence, and symptom management and these differences will be sustained at 8 and at 12 weeks. In addition, the experimental arm will report lower rates of both over and under adherence at 4, 8, and 12 weeks. Exploratory aims assess the moderating effects patient and treatment variables on adherence and symptom management. A final exploratory aim evaluates an important but heretofore untested question: what is the relationship between adherence and patients' symptom management? This research is guided by past trials and a large pilot study of adherence to oral agents and symptom management. Patient reported adherence is validated against pill counts, and scripts from patients' records. Daily reminders include a question to determine if dose was changed. If this occurs, staff in each site monitor visits and calls so that reminders are stopped or adjusted to dose immediately upon any alteration. All strategies for managing symptoms are evidence based and tested through earlier work of this team. Symptoms reaching urgent levels are communicated to staff at each site. This trial is coordinated through a project website. The impact of this trial is that it tests a short targeted reminder system to model adherence at the onset of treatment. It is accompanied by patient centered strategies for symptom management. This system is embedded into oncology centers; it can potentially transform oral chemotherapy treatment while assuring patient safety.