Jones Katie Fitzgerald, White Gretchen, Bennett Antonia, Bulls Hailey, Escott Paula, Orris Sarah, Escott Elizabeth, Fischer Stacy, Hamm Megan, Krishnamurti Tamar, Wong Risa, LeBlanc Thomas W, Liebschutz Jane, Meghani Salimah, Smith Cardinale, Temel Jennifer, Ritchie Christine, Merlin Jessica S
New England Geriatrics Research, Education, and Clinical Center (GRECC), Jamaica Plain, MA, United States.
University of Pittsburgh, Pittsburgh, PA, United States.
JMIR Res Protoc. 2024 Mar 13;13:e54953. doi: 10.2196/54953.
Opioids are a key component of pain management among patients with metastatic cancer pain. However, the evidence base available to guide opioid-related decision-making in individuals with advanced cancer is limited. Patients with advanced cancer or cancer that is unlikely to be cured frequently experience pain. Opioids are a key component of pain management among patients with metastatic cancer pain. Many individuals with advanced cancer are now living long enough to experience opioid-related harm. Emerging evidence from chronic noncancer pain literature suggests that longer-term opioid therapy may have limited benefits for pain and function, and opioid-related harms are also a major concern. However, whether these benefits and harms of opioids apply to patients with cancer-related pain is unknown.
This manuscript outlines the protocol for the "Opioid Therapy for Pain in Individuals With Metastatic Cancer: The Benefits, Harms, and Stakeholder Perspectives (BEST) Study." The study aims to better understand opioid decision-making in patients with advanced cancer, along with opioid benefits and harms, through prospective examination of patients' pain experiences and opioid side effects and understanding the decision-making by patients, care partners, and clinicians.
This is a multicenter, prospective cohort study that aims to enroll 630 patients with advanced cancer, 20 care partners, and 20 clinicians (670 total participants). Patient participants must have an advanced solid cancer diagnosis, defined by the American Cancer Society as cancer that is unlikely to be cured. We will recruit patient participants within 12 weeks after diagnosis so that we can understand opioid benefits, harms, and perspectives on opioid decision-making throughout the course of their advanced cancer (up to 2 years). We will also specifically elicit information regarding long-term opioid use (ie, opioids for ≥90 consecutive days) and exclude patients on long-term opioid therapy before an advanced cancer diagnosis. Lived-experience perspectives related to opioid use in those with advanced cancer will be captured by qualitative interviews with a subset of patients, clinicians, and care partners. Our data collection will be grounded in a behavioral decision research approach that will allow us to develop future interventions to inform opioid-related decision-making for patients with metastatic cancer.
Data collection began in October 2022 and is anticipated to end by November 2024.
Upon successful execution of our study protocol, we anticipate the development of a comprehensive evidence base on opioid therapy in individuals with advanced cancer guided by the behavioral decision research framework. The information gained from this study will be used to guide interventions to facilitate opioid decisions among patients, clinicians, and care partners. Given the limited evidence base about opioid therapy in people with cancer, we envision this study will have significant real-world implications for cancer-related pain management and opioid-related clinical decision-making.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54953.
阿片类药物是转移性癌痛患者疼痛管理的关键组成部分。然而，可用于指导晚期癌症患者阿片类药物相关决策的证据基础有限。晚期癌症患者或不太可能治愈的癌症患者经常会经历疼痛。阿片类药物是转移性癌痛患者疼痛管理的关键组成部分。许多晚期癌症患者现在存活时间足够长，会经历与阿片类药物相关的伤害。来自慢性非癌性疼痛文献的新证据表明，长期阿片类药物治疗对疼痛和功能的益处可能有限，且与阿片类药物相关的伤害也是一个主要问题。然而，这些阿片类药物的益处和危害是否适用于癌症相关疼痛患者尚不清楚。
本手稿概述了“转移性癌症患者疼痛的阿片类药物治疗：益处、危害及利益相关者观点（BEST）研究”的方案。该研究旨在通过前瞻性检查患者的疼痛经历和阿片类药物副作用，并了解患者、护理伙伴和临床医生的决策过程，更好地理解晚期癌症患者的阿片类药物决策以及阿片类药物的益处和危害。
这是一项多中心前瞻性队列研究，旨在招募630例晚期癌症患者、20名护理伙伴和20名临床医生（共670名参与者）。患者参与者必须有晚期实体癌诊断，美国癌症协会将其定义为不太可能治愈的癌症。我们将在诊断后12周内招募患者参与者，以便我们能够了解他们在整个晚期癌症病程（长达2年）中阿片类药物的益处、危害以及对阿片类药物决策的看法。我们还将特别收集有关长期使用阿片类药物（即连续使用阿片类药物≥90天）的信息，并排除在晚期癌症诊断前接受长期阿片类药物治疗的患者。通过对部分患者、临床医生和护理伙伴进行定性访谈，获取与晚期癌症患者阿片类药物使用相关的生活经历观点。我们的数据收集将基于行为决策研究方法，这将使我们能够开发未来的干预措施，为转移性癌症患者的阿片类药物相关决策提供信息。
数据收集于2022年10月开始，预计2024年11月结束。
在成功执行我们的研究方案后，我们预计将在行为决策研究框架的指导下，为晚期癌症患者开发一个关于阿片类药物治疗的综合证据基础。从这项研究中获得的信息将用于指导干预措施，以促进患者、临床医生和护理伙伴之间的阿片类药物决策。鉴于关于癌症患者阿片类药物治疗的证据基础有限，我们设想这项研究将对癌症相关疼痛管理和阿片类药物相关临床决策产生重大的现实意义。
国际注册报告识别码（IRRID）：DERR1-10.2196/54953
