Longitudinal assessment of benefits and harms of cannabis use among community-based cancer patients during initial cancer treatment

对社区癌症患者在初始癌症治疗期间使用大麻的益处和危害的纵向评估

• 批准号: 10790738
• 负责人: Reina Haque
• 金额: $ 70.01万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10790738
• 关键词: Adjuvant; Adult; Affect; Age; Alcohols; Anxiety; Biological Response Modifier Therapy; California; Cancer Patient; Cannabidiol; Cannabinoids; Cannabis; Caring; Clinical; Clinical Data; Cohort Studies; Colorectal; Colorectal Cancer; Communities; Community Health; Complementary Health; Consumption; Data; Data Set; Diagnosis; Drug Interactions; Drug Prescriptions; Educational workshop; Effectiveness; Electronic Health Record; Eligibility Determination; Emotional; Enrollment; Ensure; Fracture; Health Personnel; Healthcare; Individual; Ingestion; Inhalation; Injury; Investigation; Knowledge; Legal; Literature; Longitudinal, observational study; Malignant Neoplasms; Measures; Mediating; Mediation; Medical; Memory; Mental Depression; National Cancer Institute; Nausea; Nausea and Vomiting; Newly Diagnosed; Non-Hodgkin' s Lymphoma; Non-Small-Cell Lung Carcinoma; Observational Study; Oncologist; Oncology; Opioid; Pain; Pain management; Palliative Care; Participant; Patient Outcomes Assessments; Patients; Persons; Physical Function; Policies; Provider; Psychometrics; Recommendation; Recording of previous events; Reporting; Research; Risk; Safety; Sales; Sleep disturbances; Sleeplessness; Social Functioning; Source; Subgroup; Surveys; Symptoms; Tobacco use; Validity of Self Report; appetite loss; cancer care; cancer therapy; cannabinoid drug; cannabinoid treatment; care delivery; care outcomes; chemotherapy; chronic pain; chronic pain management; cognitive function; comorbidity; emotional functioning; evidence base; experience; follow-up; health care settings; health plan; health related quality of life; improved; infection rate; infection risk; instrument; marijuana legalization; marijuana use; marijuana use disorder; neoplasm registry; opioid use; prescription opioid; prospective; response; sex; symptom management

Despite federal prohibition on the sale or prescribing of cannabis and cannabinoids (CAC), their medical use has been legalized in 37 states. Although there is limited evidence of its effectiveness, 18-42% of persons with cancer report using CAC to help manage symptoms, most of whom obtain advice from local CAC dispensaries rather than their oncology providers. Almost 50% of oncologists recommend CAC for their patients, but <30% feel sufficiently informed to make specific recommendations. Thus, there is an urgent need for more research to guide both patients and providers on the optimal use of CAC in oncology care. There is strong evidence on the benefits of CAC for the treatment of chemotherapy-induced nausea and vomiting and for mitigating general chronic pain. There is weaker evidence on the effectiveness of CAC to help manage other symptoms that many persons with cancer report using it for, including appetite loss, depression, anxiety, and insomnia. No studies have been done on whether CAC use by cancer patients changes their use of standard palliative therapies, such as opioids to manage pain, and the mechanism by which this occurs. Well-known negative effects of CAC use have not been well studied, and may include an increased risk of infections, injuries, reduced memory and concentration, cannabis use disorder, and increased use of tobacco and alcohol. In response to these knowledge gaps, we propose a longitudinal observational study in a community-based health care setting comparing CAC users to non-users on the safety and effectiveness of CAC. We will enroll persons with incident colorectal or non-small cell lung cancer, or with non-Hodgkin Lymphoma, who are initiating systemic primary or adjuvant cancer therapy. We anticipate that 25% of the study cohort will report using CAC based on prior surveys and our preliminary data. We will survey persons soon after therapy is started, and conduct follow-up surveys 2, 4, 6, and 12 months later. We will use validated survey instruments to collect CAC use, and use PROMISÒ measures to capture patient reported outcomes (PROs). To obtain more granular details on CAC use for symptom control, we will also conduct brief (5 minute), weekly, daily assessments in a subset (n=500) of subjects, including all CAC users. We will conduct our study within the Kaiser Permanente Southern California health plan to capitalize on the availability of a high volume of eligible cases and comprehensive electronic health records containing essential clinical data. Our specific aims are to: 1. Assess the effects of CAC use on PROs, focusing on pain, nausea, anxiety, depression, insomnia, appetite loss, and overall HRQOL (defined by physical, emotional, social functioning) among persons undergoing active systemic cancer therapy; 2. Assess whether and how CAC use affects the use of standard palliative therapies, such as reducing the use of opioids; and 3. Assess the negative effects from CAC use. The rapid increase in CAC use by cancer patients has occurred despite the lack of evidence about its effectiveness and safety. Our study will inform the best clinical strategies and policies for limiting potential harms and enhancing benefits.

尽管联邦禁止销售或处方大麻和大麻素(CAC)，但它们的医疗用途 已在37个州合法化。尽管其有效性的证据有限，但18%-42%的人患有 癌症报告使用CAC帮助管理症状， 他们中的大多数人从当地CAC药房获得建议 而不是他们的肿瘤学提供者。近50%的肿瘤学家建议他们的患者使用CAC，但30%的人建议使用CAC 我觉得自己消息灵通，可以提出具体的建议。因此，迫切需要进行更多的研究。 指导患者和提供者在肿瘤护理中最佳使用CAC。有确凿的证据表明 CAC治疗化疗所致恶心呕吐和缓解全身症状的益处 慢性疼痛。关于CAC帮助管理其他症状的有效性的证据较弱 据报道，许多癌症患者使用它来治疗食欲不振、抑郁、焦虑和失眠。不是 已经有研究表明，癌症患者使用CAC是否会改变他们对标准姑息药的使用 止痛的阿片类药物等治疗方法，以及疼痛发生的机制。众所周知的负片 使用CAC的影响尚未得到很好的研究，可能包括增加感染、伤害、 记忆力和注意力下降，大麻使用障碍，吸烟和酒精使用增加。在……里面 针对这些知识差距，我们提出了一项以社区为基础的纵向观察性研究 卫生保健环境比较CAC使用者和非使用者CAC的安全性和有效性。我们将招收 患有结直肠癌或非小细胞肺癌，或患有非霍奇金淋巴瘤的人士， 启动全身性的主要或辅助癌症治疗。我们预计25%的研究队列将报告 根据以前的调查和我们的初步数据使用CAC。我们将在治疗后不久对患者进行调查 开始，并在2个月、4个月、6个月和12个月后进行跟踪调查。我们将使用经过验证的调查工具 收集CAC使用情况，并使用Promis措施捕获患者报告的结果(PRO)。为了获得 有关CAC用于症状控制的更详细信息，我们还将每周、每天进行简短(5分钟) 评估对象子集(n=500)，包括所有CAC用户。我们的研究将在 Kaiser Permanente南加州健康计划利用大量符合条件的 病例和包含基本临床数据的全面电子健康记录。我们的具体目标是： 1.评估CAC的使用对专业人士的影响，重点是疼痛、恶心、焦虑、抑郁、失眠、食欲 失落和总体HRQOL(由身体、情感、社会功能定义) 全身癌症治疗；2.评估CAC的使用是否以及如何影响标准姑息疗法的使用， 例如减少阿片类药物的使用；以及3.评估使用CAC的负面影响。快速增长的 尽管缺乏关于CAC有效性和安全性的证据，癌症患者仍使用CAC。我们的 研究将为限制潜在危害和提高益处的最佳临床战略和政策提供信息。