Opioid therapy for pain in individuals with metastatic cancer: benefits, harms and stakeholder perspectives

阿片类药物治疗转移性癌症患者的疼痛：益处、危害和利益相关者的观点

• 批准号: 10280057
• 负责人: Jessica S Merlin
• 金额: $ 73.92万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10280057
• 关键词: Accounting; Age; Area; Behavioral; Belief; Benefits and Risks; Benzodiazepines; Body part; Characteristics; Collaborations; Data; Data Collection; Decision Making; Decision Modeling; Disease; Disseminated Malignant Neoplasm; Distant; Dose; Drowsiness; Drug Prescriptions; Effectiveness; Effectiveness of Interventions; Event; Family Caregiver; Funding; Geography; Goals; Guidelines; Health; Individual; Intervention; Intervention Studies; Interview; Lead; Life; Literature; Malignant Neoplasms; Measures; Medical Records; Mental Health; Methodology; Mission; Modeling; Mood Disorders; National Cancer Institute; National Institute of Nursing Research; Newly Diagnosed; Oncology; Opioid; Outcome Assessment; Outcome Measure; Overdose; Pain; Pain interference; Pain management; Palliative Care; Palliative Care Nursing; Patient Care; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Placebo Control; Population; Prospective cohort; Recommendation; Recording of previous events; Research; Research Priority; Risk; Risk Factors; Series; Severities; Site; Substance Use Disorder; Testing; Time; Work; addiction; chronic pain patient; decision research; evidence base; experience; follow-up; improved; insight; morphine equivalent; non-cancer chronic pain; novel; opioid misuse; opioid sparing; opioid therapy; opioid use; opioid use disorder; palliate; patient subsets; prescription opioid; primary outcome; programs; side effect; stakeholder perspectives; standard of care

Project Summary Opioid therapy for pain in patients with metastatic cancer is a critical yet understudied area. Pain is experienced at some point by most patients with metastatic cancer. Prescribed opioids are a cornerstone of treating pain; the prevalent belief in the field has been that the benefits of palliating pain in metastatic cancer with opioids nearly always outweigh any potential harms. This approach to opioid-related decisions in patients with metastatic cancer implies that patients’ prognoses are either so short that these harms are not meaningful, or that benefits of opioids are substantial while harms are relatively minimal. Research on the benefits and harms of opioid therapy has exploded in the past decade but primarily focuses on individuals with chronic “non-cancer” pain. However, patients with cancer have been routinely excluded from these studies and resulting recommendations that favor more conservative opioid prescribing. The few studies of patients with cancer generally support that serious harms occur, but have significant methodologic limitations. Additionally, there are unique considerations in individuals with metastatic cancer, including life-limiting disease that may last years, high pain rates, and opioids as accepted standard of care. Therefore, assessing benefits and risk factors for opioid-related harms in individuals with metastatic cancer is a critical gap in the literature and key to opioid-related decision-making. The long-term goal of this program of research is to develop interventions that inform opioid-related decision-making for patients with metastatic cancer. We will use the Behavioral Decision Research framework to create a comprehensive evidence base on which these interventions can be grounded, which is the objective of the present application. To accomplish our aims, we have partnered with the NINR- funded Palliative Care Research Cooperative to develop a prospective cohort of patients newly diagnosed with metastatic cancer. We propose the following Aims in patients with metastatic cancer: Aim 1: Investigate the relationship between opioid therapy and opioid-related benefits. Hypothesis 1: Opioid therapy will be associated with decreased pain severity and pain interference (co-primary outcomes). Aim 2: Investigate risk factors for opioid-related harms. Hypothesis 2a: Certain co-prescribed medications will be associated with increased risk of opioid side effects (e.g., benzodiazepines and somnolence). Hypothesis 2b: Younger age, history of substance use disorder, and history of mood disorders will be associated with greater risk of opioid misuse and use disorder. Approach: We will use linear mixed effects models (2a) and time-to-event analyses (2b). Aim 3: Understand stakeholder (patient, family caregiver, clinician) perspectives on opioid-related decision-making. Completion of these aims will lead directly to an R-series proposal to develop and test a novel intervention to inform opioid decision-making, followed by R-series proposals to study intervention effectiveness and implementation. This work has the potential to transform opioid prescribing and pain management for patients with metastatic cancer.

项目摘要 转移性癌症患者疼痛的阿片类药物治疗是一个关键的领域。疼痛是 大多数转移性癌症患者在某些时候经历了经验。规定的阿片类药物是 治疗疼痛；对该领域的普遍信念是，转移性癌症疼痛的益处 卵形药物几乎总是超过任何潜在的危害。患者中与卵巢类药物相关的决策的方法 发生转移性癌症意味着患者的预后要么很短，因此这些危害不是 有意义的，或者阿片类药物的好处是很大的，而危害相对较小。研究 在过去的十年中，阿片类药物疗法的益处和伤害一直在探讨 慢性“非癌症”疼痛。但是，癌症患者通常被排除在这些研究之外， 由此有利于更保守的阿片类药物处方的建议。少数患者的研究 癌症通常支持发生严重危害，但具有重大的方法论局限性。此外， 转移性癌症患者有独特的考虑，包括生命疾病 去年，高疼痛率和阿片类药物是公认的护理标准。因此，评估福利和风险 转移性癌症患者阿片类药物相关的危害因素是文献中的一个关键差距，也是关键的关键。 与阿片类药物有关的决策。该研究计划的长期目标是制定干预措施 为转移性癌症患者提供与阿片类药物相关的决策。我们将使用行为决定 研究框架以创建一个全面的证据基础，以此为基础，这些干预措施可以扎根 这是本应用的目的。为了实现我们的目标，我们与尼尔合作 资助的姑息治疗研究合作社，开发了新诊断的患者的预期队列 转移性癌。我们在转移性癌症患者中提出以下目标：目标1：调查 阿片类药物治疗与阿片类药物相关的益处之间的关系。假设1：阿片类药物治疗将是 与疼痛严重程度减轻和疼痛干扰有关（共同结局）。目标2：调查风险 阿片类药物相关危害的因素。假设2a：某些共同处方药将与 阿片类药物副作用的风险增加（例如苯二氮卓类和嗜睡）。假设2b：年轻年龄， 药物使用障碍的史和情绪障碍史将与更大的OOID风险相关 滥用和使用障碍。方法：我们将使用线性混合效应模型（2A）和事件时间分析 （2b）。目标3：了解利益相关者（患者，家庭护理人员，临床）与阿片类药物有关的观点 决策。这些目标的完成将直接提出R系列提案，以开发和测试 新的干预措施，以告知阿片类药物决策，然后是R系列提案以研究干预措施 有效性和实施。这项工作有可能改变阿片类药物的处方和痛苦 转移性癌症患者的管理。