Cannabis use and outcomes in ambulatory patients with cancer: A 12-month cohort study

门诊癌症患者的大麻使用和结果：一项为期 12 个月的队列研究

基本信息

批准号：
10610465
负责人：
Rebecca Ashare
金额：
$ 64.26万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-15 至 2027-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10610465
关键词：
Adjuvant Analgesic Adult African American American Anxiety Cancer Pain Management Cancer Patient Cancer Science Cannabidiol Cannabinoids Cannabis Cannabis policy Characteristics Classification Clinical Clinical Practice Guideline Cohort Studies Cross-Sectional Studies Data Databases District of Columbia Ecological momentary assessment Enrollment Exhibits Female Frequencies Funding Agency Guidelines Health system Hydrocodone Inhalation Interdisciplinary Study Knowledge Laws Malignant Neoplasms Marijuana Measures Medical Medical Marijuana Medical Oncologist Medicine Methodology National Cancer Institute National Comprehensive Cancer Network New England Oncologist Oncology Opioid Oral Outcome Oxycodone Pain Pain management Patient Outcomes Assessments Patients Pharmaceutical Preparations Plants Practice Guidelines Prospective cohort Quality of life Race Recommendation Reporting Research Research Design Respondent Role Route Sampling Schedule Science Severities Site Sleep Sleeplessness Solid Source Surveys Telephone Testing Tetrahydrocannabinol Time United States United States Food and Drug Administration Work cancer health disparity cancer pain cancer therapy cannabis use behavior clinical practice design falls health disparity improved indexing interest marijuana legalization marijuana use marijuana user opioid misuse opioid therapy opioid use pain outcome pill prescription monitoring program prescription opioid racial disparity side effect substance misuse symptom management tumor

项目摘要

PROJECT ABSTRACT Between 24-40% of cancer patients in the U.S. use cannabis, principally to manage pain, anxiety, and insomnia. Importantly, evidence suggests that some patients may be substituting cannabis as a strategy to reduce opioid consumption. However, cannabis’ historical classification as a Schedule I substance (i.e., a controlled substance with no known medical use) by the United States (U.S.) Food and Drug Administration has created barriers to conducting rigorous research on its role in cancer symptom management. As a result, the 2021 National Comprehensive Cancer Network’s Adult Cancer Pain guidelines state: “Data supporting the use of cannabinoids as adjuvant analgesics for treatment of cancer pain are extremely limited and the results from what data exist are somewhat conflicting”. Moreover, despite abundant evidence of racial disparities in cancer pain treatment, little is known about the role of cannabis in mitigating racial disparities in cancer pain outcomes. Thus, there is a critical need to conduct rigorously designed research to generate new knowledge of this phenomenon. Using ecological momentary assessment (EMA) methodology and a 12-month prospective cohort design, we propose a multisite study at three health systems in the northeastern U.S. We will enroll 600 (200 per site) ambulatory patients with non-skin solid malignancies who are receiving opioid therapy: 300 cannabis users (weekly use in any form in the prior month) and 300 cannabis non-users (no use in the past 3 months). Of these, 50% will be self-identified African American patients and 50% will be White. Cannabis and opioid use will be assessed via EMA (collected for 1 week/month; 84 days total) and monthly phone surveys and patient reported outcomes (PROs) will be assessed via monthly phone surveys. This study will also describe the poorly understood phenomenon of cannabis use patterns over time by elucidating dynamic within- and between-subject changes in cannabis use, PROs, and opioid use over the course of one year. The Specific Aims are to: (1) describe dynamic within- and between-subject changes in cannabis use over time including frequency, route, source (medical vs. non-medical), indication, and composition; (2) assess if cannabis use over time is associated with key PROs (pain severity and pain-related function, sleep, anxiety, and quality of life) and opioid use (subjective and objective indices) among cancer patients; (3) test if cannabis use moderates the association between race and pain severity; and (4) explore potential moderators of the relationship among cannabis use, PROs, and opioid use including cannabis frequency, source, route, and composition, and current opioid misuse measure. This timely and comprehensive study has high potential to generate new knowledge upon which clinical practice and guidelines related to cannabis use in cancer pain and symptom management may be based. The strong multidisciplinary research team brings the requisite expertise in cancer-related pain, medical cannabis, longitudinal opioid use among patients with cancer, substance misuse, and health disparities. Overall, this research can have a sustained impact on the science of cancer pain and symptom management.

项目摘要美国 24-40% 的癌症患者使用大麻，主要是为了缓解疼痛、焦虑和失眠。重要的是，有证据表明一些患者可能会用大麻代替大麻作为减少阿片类药物的策略然而，大麻历史上被归类为附表一物质（即受控物质）。没有已知的医疗用途）美国食品和药物管理局设置了障碍对其在癌症症状管理中的作用进行了严格的研究，因此，2021 年国家癌症中心。综合癌症网络的成人癌症疼痛声明：“支持大麻素使用指南的数据因为用于治疗癌症疼痛的辅助镇痛药极其有限，并且现有数据的结果此外，尽管有大量证据表明癌症疼痛治疗存在种族差异，人们对大麻在减轻癌症疼痛结果的种族差异方面的作用知之甚少。迫切需要进行严格设计的研究，以产生有关这一现象的新知识。我们建议采用生态瞬时评估（EMA）方法和 12 个月的前瞻性队列设计在美国东北部三个卫生系统进行的多地点研究。我们将招募 600 名（每个地点 200 名）门诊患者接受阿片类药物治疗的非皮肤实体恶性肿瘤患者：300 名大麻使用者（每周使用上个月的任何形式）和 300 名非大麻使用者（过去 3 个月内未使用大麻）。自我认定的非裔美国患者，其中 50% 为白人，大麻和阿片类药物的使用情况将通过评估。 EMA（收集 1 周/月；总共 84 天）和每月电话调查以及患者报告的结果（PRO）将通过每月电话调查进行评估。这项研究还将描述人们知之甚少的问题。通过阐明受试者内部和受试者之间的动态变化，研究大麻使用模式随时间的变化一年内大麻使用、PRO 和阿片类药物使用的具体目标是： (1) 描述。随着时间的推移，受试者体内和受试者之间大麻使用的动态变化，包括频率、途径、来源（医疗与非医疗）、适应症和成分；(2) 评估长期使用大麻是否与以下因素有关：关键 PRO（疼痛严重程度和疼痛相关功能、睡眠、焦虑和生活质量）和阿片类药物使用（主观 (3) 测试大麻的使用是否会缓和种族之间的关联和疼痛严重程度；(4) 探索大麻使用、PRO 和之间关系的潜在调节因素阿片类药物的使用，包括大麻频率、来源、途径和成分，以及当前阿片类药物滥用措施。这项及时而全面的研究具有很大的潜力，可以产生临床实践所需的新知识与大麻在癌症疼痛和症状管理中的使用相关的指南可能以此为基础。多学科研究团队带来了癌症相关疼痛、医用大麻、癌症患者中阿片类药物的纵向使用、药物滥用和健康差异总体而言。研究可以对癌症疼痛和症状管理科学产生持续影响。