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

• 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
• 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

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 在美国，在24-40％的癌症患者中，主要用于管理疼痛，焦虑和失眠。 重要的是，有证据表明，有些患者可以将大麻替代作为减少Ooid的策略。 消耗。但是，大麻的历史分类作为时间表I物质（即受控物质 美国（美国）食品和药物管理局没有已知的医疗用途）为 对其在癌症症状管理中的作用进行严格的研究。结果，2021年国民 综合癌症网络的成人癌症疼痛指南指出：“支持使用大麻素的数据 由于调整镇痛药治疗癌症疼痛非常有限，并且存在数据的结果 此外。此外，目的地丰富的癌症疼痛治疗中种族差异的证据， 关于大麻在减轻癌症疼痛结果中赛车差异中的作用知之甚少。那有一个 进行严格设计的研究以产生这种现象的新知识的批判性需求。使用 生态瞬时评估（EMA）方法论和12个月的前瞻性队列设计，我们建议 在美国东北部的三个卫生系统中进行的多站点研究，我们将注册600（每个站点200） 接受阿片类药物治疗的非皮肤固体恶性肿瘤的患者：300大麻使用者（每周使用 上个月的任何形式）和300名大麻非用户（在过去的3个月中无用）。其中，有50％将是 自我识别的非裔美国人患者和50％的患者将是白人。大麻和阿片类药物的使用将通过 EMA（收集1周/月；总计84天）和每月电话调查和患者报告的结果 （优点）将通过每月电话调查评估。这项研究还将描述知之甚少的 大麻现象随着时间的推移使用模式，通过阐明受试者内部和受试者之间的动态变化 在一年的时间内，在大麻中使用，优点和阿片类药物的使用。具体目的是：（1）描述 随着时间的时间使用大麻的动态内部和受试者之间的变化，包括频率，路线，源 （医学与非医学），指示和组成； （2）评估大麻是否随着时间的推移而与 关键优点（疼痛严重程度和与疼痛有关的功能，睡眠，焦虑和生活质量）和阿片类药物使用（主观 癌症患者中的客观指数）； （3）测试大麻使用是否会调节种族之间的关联 和疼痛的严重程度； （4）探索大麻使用，优点和 Ooid的使用，包括大麻频率，来源，路线和组成以及当前的Ooid Missuse测量。 这项及时，全面的研究具有很高的潜力，可以在哪些临床实践上产生新知识 与大麻使用有关癌症疼痛和症状管理有关的指南可能是基于的。坚强 多学科研究团队带来了与癌症相关疼痛的必要专业知识，医用大麻， 癌症患者，药物滥用和健康差异的纵向阿片类药物使用。总体而言，这 研究可以持续对癌症疼痛和症状管理的科学产生影响。