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开具大麻和大麻素 (CAC) 处方，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% 的患者 癌症报告使用 CAC 来帮助管理症状， 大多数人从当地 CAC 药房获取建议 而不是他们的肿瘤学提供者。近 50% 的肿瘤学家建议其患者使用 CAC，但<30% 感到有足够的信息来提出具体建议。因此，迫切需要进行更多研究 指导患者和医疗服务提供者在肿瘤护理中最佳使用 CAC。有强有力的证据表明 CAC 治疗化疗引起的恶心和呕吐以及减轻一般症状的益处 慢性疼痛。关于 CAC 帮助管理其他症状的有效性的证据较弱 许多癌症患者报告使用它来治疗食欲不振、抑郁、焦虑和失眠。不 已经开展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 疗法，例如用于控制疼痛的阿片类药物，以及发生这种情况的机制。众所周知的负面 使用 CAC 的影响尚未得到充分研究，可能包括增加感染、受伤、 记忆力和注意力下降、大麻使用障碍以及烟草和酒精的使用增加。在 为了应对这些知识差距，我们提出了一项基于社区的纵向观察研究 医疗保健机构将 CAC 用户与非用户的 CAC 安全性和有效性进行比较。我们将报名 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， 开始全身性主要或辅助癌症治疗。我们预计 25% 的研究队列将报告 根据之前的调查和我们的初步数据使用 CAC。治疗结束后我们将立即对患者进行调查 开始，并在2、4、6、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 PROMISÒ 措施来获取患者报告结果 (PRO)。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） 对受试者子集 (n=500)（包括所有 CAC 用户）进行评估。我们将在以下范围内进行研究 Kaiser Permanente 南加州健康计划将利用大量符合条件的人 病例和包含重要临床数据的综合电子健康记录。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 经历积极活动的人的损失和总体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； 3. 评估使用 CAC 的负面影响。迅速增加 尽管缺乏证据证明 CAC 的有效性和安全性，但癌症患者仍然使用 CAC。我们的 研究将为限制潜在危害和增强益处的最佳临床策略和政策提供信息。