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.

尽管联邦禁止大麻和大麻素（CAC）出售或处方，但他们的医疗用途 已在37个州合法化。尽管证据证明其有效性有限，但有18-42％的人 使用CAC帮助管理符号的癌症报告， 大多数人从当地的CAC药房获得建议 而不是他们的肿瘤学提供者。几乎50％的肿瘤学家为患者推荐CAC，但<30％ 感到足够的知情以提出具体的建议。那迫切需要更多的研究 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 CAC治疗化学疗法引起的恶心和呕吐的好处以及减轻一般 慢性疼痛。关于CAC的有效性帮助管理其他症状的证据较弱 许多患有癌症的人报告使用它，包括食欲不振，抑郁，焦虑和失眠。不 已经完成了有关癌症患者使用CAC是否改变其标准姑息治疗的研究 治疗疼痛的治疗方法以及发生这种情况的机制。众所周知的负面 CAC使用的影响还没有很好地研究，并且可能包括增加感染的风险，受伤， 记忆力和浓度降低，大麻使用障碍以及烟草和酒精的使用增加。 对这些知识差距的响应，我们提出了一项基于社区的纵向观察性研究 医疗保健设置将CAC用户与非用户有关CAC的安全性和有效性进行比较。我们将注册 患有大肠或非小细胞肺癌的患者或非霍奇金淋巴瘤 启动全身性原发性或可调癌症。我们预计25％的研究队列将报告 根据先前的调查和我们的初步数据使用CAC。治疗后，我们将很快进行调查 开始并进行后续调查2、4、6和12个月。我们将使用经过验证的调查工具 收集CAC使用，并使用Promisò措施来捕获患者报告的结果（PRO）。获得 有关CAC使用症状控制的更多细节细节，我们还将进行简短（5分钟），每周，每天进行 包括所有CAC用户在内的主题子集（n = 500）的评估。我们将在 凯撒（Kaiser 案例和综合电子健康记录包含基本临床数据。我们的具体目的是： 1。评估CAC使用对专业人士的影响，专注于疼痛，恶心，焦虑，抑郁，失眠，适用性 损失和整体HRQOL（由身体，情感，社会功能定义） 全身性癌症治疗； 2。评估CAC的使用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；和3。评估CAC使用的负面影响。快速增加 尽管缺乏证据表明其有效性和安全性，但仍发生了癌症患者的CAC使用。我们的 研究将为限制潜在危害和增强收益的最佳临床策略和政策提供信息。