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.

项目概要 阿片类药物治疗转移性癌症患者的疼痛是一个关键但尚未得到充分研究的领域。 大多数转移性癌症患者在某些时候都经历过处方阿片类药物是治疗的基石。 治疗疼痛；该领域普遍认为缓解转移性癌症疼痛的好处 这种对患者做出与阿片类药物相关的决定的方法几乎总是超过任何潜在的危害。 转移性癌症意味着患者的预后要么很短，以至于这些危害不会被忽视 有意义，或者阿片类药物的益处很大，而危害相对较小。 阿片类药物治疗的益处和危害在过去十年中呈爆炸式增长，但主要集中于患有以下疾病的个体 然而，癌症患者通常被排除在这些研究之外。 由此产生的建议倾向于更保守的阿片类药物处方。针对患者的研究很少。 癌症通常支持存在严重危害，但具有显着的方法学局限性。 对于患有转移性癌症的个体，有一些独特的考虑因素，包括可能导致生命限制的疾病 近年来，疼痛发生率很高，并且阿片类药物成为公认的护理标准，因此需要评估收益和风险。 转移性癌症患者中阿片类药物相关危害的因素是文献中的一个关键空白，也是解决这一问题的关键 该研究计划的长期目标是制定与阿片类药物相关的决策。 我们将使用行为决策为转移性癌症患者提供与阿片类药物相关的决策信息。 研究框架创建一个全面的证据基础，这些干预措施可以以此为基础， 这就是本申请的目标。为了实现我们的目标，我们与 NINR 合作。 资助姑息治疗研究合作社，以开发新诊断的患者的前瞻性队列 我们对转移性癌症患者提出以下目标： 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 与疼痛严重程度降低和疼痛干扰相关（共同主要结果）。 假设 2a：某些共同处方药物与阿片类药物相关的危害有关。 阿片类药物副作用（例如苯二氮卓类药物和嗜睡）的风险增加。假设 2b：年龄较小， 物质使用障碍史和情绪障碍史与阿片类药物的更大风险相关 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、临床医生）对阿片类药物相关的看法 完成这些目标将直接导致 R 系列提案的开发和测试。 为阿片类药物决策提供信息的新型干预措施，随后是研究干预措施的 R 系列提案 这项工作的有效性和实施有可能改变阿片类药物的处方和疼痛。 转移性癌症患者的管理。