Improving Clinical Trial Participation of Older Adults with Cancer

项目概要/摘要 拟议研究的总体目标是检查肿瘤学临床试验的促进因素和障碍 招募患有癌症的老年患者（年龄> 70）。该提案涉及《公约》的一个关键科学优先事项， 国家老龄化研究所将增加老年人参与肿瘤学临床研究。这很重要 因为每四个70岁以上的美国人中就有一个在他们的一生中会被诊断出患有癌症。从2018年到 到2040年，年龄> 70岁的人的癌症发病率预计将上升88%。然而，尽管这种不成比例的 由于癌症对老年人的发病率和影响，他们在癌症临床试验中的代表性严重不足。到 确定增加老年人参与的方法，拟议的研究建立在两个初步的基础上， 这些研究强调了我们对临床试验招募的促进者和障碍的理解中的关键差距， 老年癌症患者。尽管许多研究表明，障碍是多方面的， 从系统、医生、患者和/或护理人员因素的组合来看，很少有研究前瞻性地 从患者和医生两方面研究了肿瘤临床试验招募的促进因素和障碍 观点，没有人探讨照顾者的障碍。为弥补这一差距，具体目标是： 目标1。描述参加和不参加肿瘤学的老年癌症患者（年龄> 70岁）的特征 临床试验，并确定未入组的原因;以及目标2。确定促进因素和障碍， 肿瘤临床试验从患者、护理者和患者中招募患有癌症的老年人（年龄> 70岁）， 医生的观点。在目标1中，我们将对一项国家前瞻性研究进行二级数据分析， 在国家癌症研究所社区肿瘤学研究中使用了一种临床试验筛选工具 该计划是一个由美国46个社区网站组成的联盟。在目标2中，我们将进行一项前瞻性研究， 在City of Hope和附属社区站点的40名老年癌症患者（年龄> 70岁）（20名患者 登记和20名未登记治疗性肿瘤临床试验的患者）。患者的护理人员和 此外，亦会招聘肿瘤科医生。与每个利益相关者（患者， 护理人员或肿瘤学家），以探索入组的障碍和促进因素。定量 将收集数据以确定促进者和障碍是否因患者特征而不同（即，老年 评估），护理者特征（即，照顾者负担）和肿瘤学家特征。本研究 将产生重大影响，因为它将为开发和测试战略提供路线图， 老年人参与肿瘤学研究。此外，这些研究将提供一个新的，实质性的 从目前的研究出发，同时评估病人，护理人员和医生的观点。 最后，拟议的研究将提供指导，培训和经验，将成功地 启动Sedrak博士在以患者为导向的老年肿瘤学研究方面的独立职业生涯。

PROJECT SUMMARY/ABSTRACT The overall goal of the proposed studies is to examine the facilitators and barriers to oncology clinical trial enrollment of older patients (age > 70) with cancer. This proposal addresses a key scientific priority of the National Institute on Aging to increase inclusion of older adults in oncology clinical studies. This is important because one in four Americans over the age of 70 will be diagnosed with cancer in their lifetime. From 2018 to 2040, cancer incidence is expected to rise 88% for individuals age > 70. However, despite this disproportionate incidence and impact of cancer on older adults, they are severely underrepresented in cancer clinical trials. To identify means of increasing participation of older adults, the proposed research builds on two preliminary studies that highlight key gaps in our understanding of the facilitators and barriers to clinical trial enrollment of older adults with cancer. Although numerous studies have shown that the barriers are multifaceted, arising from a combination of system, physician, patient, and/or caregiver factors, few studies have prospectively examined the facilitators and barriers to oncology clinical trial enrollment from both the patient and physician perspectives, and none have explored the caregiver barriers. To address this gap, the Specific Aims are to: Aim 1. Describe the characteristics of older adults (age > 70) with cancer who do and do not enroll in oncology clinical trials, and determine the reasons for non-enrollment; and Aim 2. Identify the facilitators and barriers to oncology clinical trial enrollment of older adults (age > 70) with cancer from the patient, caregiver, and physician perspectives. In Aim 1, we will perform a secondary data analysis of a national prospective study that used a clinical trial screening tool within the National Cancer Institute Community Oncology Research Program, a consortium of 46 community sites across the US. In Aim 2, we will conduct a prospective study of 40 older patients (age > 70) with cancer at City of Hope and affiliated community sites (20 patients who do enroll and 20 patients who do not enroll in a therapeutic oncology clinical trial). Patients’ caregivers and oncologists will also be recruited. Qualitative semi-structured interviews with each stakeholder (patient, caregiver, or oncologist) will be conducted to explore the barriers and facilitators to enrollment. Quantitative data will be collected to determine if facilitators and barriers differ by patient characteristics (i.e., geriatric assessment), caregiver characteristics (i.e., caregiver burden), and oncologist characteristics. This research will have significant impact because it will provide a roadmap for developing and testing strategies to increase participation of older adults in oncology research. Furthermore, these studies will provide a new, substantive departure from current studies by simultaneously assessing the patient, caregiver, and physician perspectives. Finally, the proposed research will provide the mentorship, training, and experience that will successfully launch Dr. Sedrak’s independent career in patient-oriented, geriatric oncology research.