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），但其医疗用途 在37个州合法化。虽然其有效性的证据有限，但18-42%的人 癌症报告使用CAC来帮助控制症状， 他们中的大多数人从当地的CAC诊所获得建议， 而不是他们的肿瘤学提供者。几乎50%的肿瘤学家建议他们的患者使用CAC，但<30%的患者建议使用CAC。 有足够的信息提出具体建议。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。有强有力的证据表明， CAC在治疗化疗引起的恶心和呕吐以及减轻全身 慢性疼痛有较弱的证据表明，CAC的有效性，以帮助管理其他症状， 许多癌症患者报告使用它，包括食欲不振，抑郁，焦虑和失眠。没有 已经进行了关于癌症患者使用CAC是否会改变他们对标准姑息治疗的使用的研究， 治疗，如阿片类药物来管理疼痛，以及发生这种情况的机制。知名负面 CAC使用的影响尚未得到很好的研究，可能包括感染，受伤， 记忆力和注意力下降，大麻使用障碍，烟草和酒精使用增加。在 针对这些知识差距，我们提出了一项基于社区的纵向观察研究。 比较CAC使用者与非使用者在CAC安全性和有效性方面的医疗保健环境。我们将招收 患有结肠直肠癌或非小细胞肺癌或非霍奇金淋巴瘤的人， 启动全身性原发性或辅助癌症治疗。我们预计25%的研究队列将报告 使用CAC基于先前的调查和我们的初步数据。我们将在治疗结束后不久进行调查。 开始，并在2个月、4个月、6个月和12个月后进行随访调查。我们将使用经过验证的调查工具 收集CAC的使用情况，并使用PROMISCITY指标获取患者报告的结局（PRO）。获得 关于CAC用于症状控制的更详细信息，我们还将进行简短（5分钟），每周，每天 受试者子集（n=500）的评估，包括所有CAC使用者。我们将在 Kaiser Permanente Southern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使用对PRO的影响，重点关注疼痛、恶心、焦虑、抑郁、失眠、食欲 损失和整体HRQOL（由身体，情绪，社会功能定义）在经历积极的人 全身性癌症治疗; 2.评估CAC的使用是否以及如何影响标准姑息治疗的使用， 例如减少阿片类药物的使用; 3.评估CAC使用的负面影响。迅速增加 尽管缺乏关于其有效性和安全性的证据，但癌症患者仍使用CAC。我们 研究将为限制潜在危害和提高获益的最佳临床策略和政策提供信息。