The Role of Opioid Adherence Profiles in Cancer Pain Self-Management and Outcomes

摘要/项目摘要 疼痛是对癌症患者生活质量产生最大负面影响的首要症状之一。 不幸的是，三分之一的癌症患者会经历中度到重度的疼痛，原因是 癌症，它的治疗，或者两者兼而有之。三分之一的人在完成积极的癌症治疗后会持续疼痛。 美国有1550万癌症患者，这是一个重大的公共卫生问题。虽然很多人 补充和替代医学方法已经存在，它们在癌症疼痛的临床应用仍然很严重。 由于缺乏有力的证据、短期的缓解和过高的自付成本而受到阻碍。反过来，阿片类疼痛 药物是开给癌症患者的--值得注意的是，他们仍然被排除在大多数州和政策之外 关于阿片类药物的倡议。长期(&gt；3 月份 阿片类药物治疗在癌症门诊患者中也很普遍，当 与年龄-性别匹配的对照组相比。尽管如此，癌症患者几乎总是 排除在外 从… T 他最近的健康状况 管理“ 研究长期阿片类药物治疗和使用的结果。 和人类 服务疼痛管理机构间特别工作组已确定“自我 作为改善慢性疼痛的最佳实践之一。然而，干预措施不能 设计是由于我们目前对癌症门诊患者疼痛自我管理和 尤其是他们的阿片类药物自我管理。最近的系统评价表明，大多数癌症疼痛 干预措施(基于知识翻译，主要或专门针对白人患者) 提高知识，但在很大程度上并不能改善对患者至关重要的结果，如日常疼痛、功能或 生活质量。这突出表明有必要继续为干预措施的发展寻找其他目标。这 为期6个月的前瞻性队列研究将产生关于纵向疼痛、阿片类药物自身的新知识 癌症门诊患者在日常疼痛、疼痛的背景下的管理轨迹和相关结果 耀斑、关键临床调节剂和协变量。总共400名癌症门诊患者(50%非裔美国人；50% 服用长效(LA)阿片类药物的女性)将从三个城市肿瘤学中心招募。 将使用药物事件监控实时捕获纵向阿片类药物自我管理模式 系统(MEMS®)。每天的背景疼痛、疼痛发作和“按需”阿片类药物的使用将通过以下方式收集 自我报告跟踪器(SRT®)。要评估的患者报告结果(PRO)是疼痛程度的变化， 与功能、睡眠和健康相关的生活质量。医疗服务结果包括计划外住院 和急诊科使用(医疗保健利用)。本研究将提供严谨的数据，全面的 一组社会人口学和临床协变量，以及进一步研究疼痛自我的关键调节因素 管理最佳做法可以作为基础，包括改善种族差距的目标。总体而言，这 研究可以对癌症疼痛管理的科学产生持续的影响。

ABSTRACT/ PROJECT SUMMARY Pain is one of the top symptoms producing the greatest negative impact on cancer patients' quality of life. Unfortunately, one in three cancer patients will experience moderate to severe pain due to consequences of cancer, its treatments or both. For one in three, pain will persist after completion of active cancer treatments. With 15.5 million Americans living with cancer, this is a substantial public health matter. While many complementary and alternative medicine approaches exist, their clinical use for cancer pain remains seriously hampered by lack of robust evidence, short-term relief, and excessive out-of-pocket costs. In turn, opioid pain medications are prescribed to cancer patients – who notably, also remain excluded from most state and policy initiatives on opioids. Long-term (>3 months ) opioid therapy is also prevalent among cancer outpatients when compared to age-sex matched controls. Despite this, cancer patients have been almost invariably excluded from T he recent Health management” studies investigating the outcomes of long-term opioid therapy and use. and Human Services Pain Management Inter-Agency Taskforce has identified “self- as one of the best practices in improving chronic pain. However,interventions cannot be designed due to serious gaps in our current understanding of cancer outpatients' pain self-management and especially their opioid self-management. Recent systematic reviews demonstrate that most cancer pain interventions (based on knowledge translation and conducted predominantly or exclusively with White patients) improve knowledge, but largely do not improve outcomes that matter to patients such as daily pain, function, or quality of life. This underscores a need to continue in search of other targets for intervention development. This 6-month prospective cohort study will generate new knowledge about longitudinal pain, opioid self- management trajectories, and associated outcomes among cancer outpatients in the context of daily pain, pain flares, key clinical moderators and covariates. A total of 400 cancer outpatients (50% African Americans; 50% women) who are prescribed long-acting (LA) opioids will be recruited from three urban oncology centers. Longitudinal opioid self-management patterns will be captured in real-time using medication event monitoring system (MEMS®). Daily background pain, pain flares, and use of “as-needed” opioids will be collected using the self-report tracker (SRT®). Patient-reported outcomes (PRO) to be assessed are changes in pain levels, function, sleep, and health-related quality of life. Health services outcomes include unplanned hospitalizations and emergency department use (healthcare utilization). This study will supply rigorous data, comprehensive set of sociodemographic and clinical covariates, and key moderators upon which further research for pain-self management best practices can be based, including targets to ameliorate racial disparities. Overall, this research can have a sustained impact on the science of cancer pain management.