Improving Clinical Trial Participation of Older Adults with Cancer

提高老年癌症患者的临床试验参与度

• 批准号: 9812036
• 负责人: Mina S Sedrak
• 金额: $ 12.98万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9812036
• 关键词: Address; Affect; Age; Aging; American; American Society of Clinical Oncology; Award; Cancer Patient; Caregiver Burden; Caregivers; Characteristics; Cities; Clinical Oncology; Clinical Research; Clinical Trials; Communities; Community Clinical Oncology Program; Complex; Data; Data Analyses; Decision Making; Development; Diagnosis; Educational workshop; Elderly; Enrollment; Foundations; Future; Geriatric Assessment; Geriatrics; Goals; Health Promotion; Incidence; Individual; Institute of Medicine (U.S.); International; Intervention Studies; Interview; K-Series Research Career Programs; Knowledge; Longevity; Malignant Neoplasms; Manuscripts; Medical Oncologist; Mentorship; Mission; Multicenter Studies; National Cancer Institute; National Institute on Aging; Older Population; Oncologist; Oral; Participant; Patients; Perception; Personal Satisfaction; Physicians; Population; Preparation; Prospective Studies; Quality of life; Research; Research Personnel; Screening procedure; Site; Societies; Structure; System; Testing; Therapeutic; Training; United States Food and Drug Administration; United States National Institutes of Health; anticancer research; cancer care; cancer clinical trial; career; ethnic minority population; evidence base; experience; improved; innovation; older patient; oncology; patient oriented; programs; prospective; racial and ethnic; recruit; rural dwellers; secondary analysis; systematic review

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.

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 老年癌症患者（年龄 > 70 岁）的入组。该提案涉及一个关键的科学优先事项 国家老龄化研究所将增加老年人参与肿瘤学临床研究的机会。这很重要 因为 70 岁以上的美国人中有四分之一在一生中会被诊断出患有癌症。从2018年到 到 2040 年，70 岁以上人群的癌症发病率预计将上升 88%。然而，尽管如此， 尽管癌症的发病率和对老年人的影响很大，但他们在癌症临床试验中的代表性严重不足。到 为了确定增加老年人参与的方法，拟议的研究建立在两项初步研究的基础上 研究强调了我们对临床试验注册的促进因素和障碍的理解上的主要差距 患有癌症的老年人。尽管大量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 研究了患者和医生参与肿瘤学临床试验的促进因素和障碍 观点，但没有人探讨护理人员的障碍。为了解决这一差距，具体目标是： 目标 1. 描述参加和未参加肿瘤学的老年癌症患者（年龄 > 70 岁）的特征 临床试验，并确定不入组的原因；目标 2. 确定促进和阻碍 肿瘤学临床试验招募患有癌症的老年人（年龄 > 70 岁），来自患者、护理人员和 医生的观点。在目标 1 中，我们将对一项全国前瞻性研究进行二次数据分析， 使用国家癌症研究所社区肿瘤学研究中的临床试验筛选工具 Program，一个由全美 46 个社区站点组成的联盟。在目标 2 中，我们将进行一项前瞻性研究 City of Hope 和附属社区站点有 40 名患有癌症的老年患者（年龄 > 70 岁）（其中 20 名患者接受了癌症治疗） 注册和 20 名未注册肿瘤治疗临床试验的患者）。患者的护理人员和 还将招募肿瘤学家。对每个利益相关者（患者、 护理人员或肿瘤学家）将进行探索入组的障碍和促进因素。定量 将收集数据以确定促进因素和障碍因素是否因患者特征（即老年病）而不同 评估）、护理人员特征（即护理人员负担）和肿瘤科医生特征。这项研究 将产生重大影响，因为它将为开发和测试策略提供路线图，以提高 老年人参与肿瘤学研究。此外，这些研究将提供新的、实质性的 通过同时评估患者、护理人员和医生的观点来偏离当前的研究。 最后，拟议的研究将提供指导、培训和经验，以成功地实现这一目标。 开启 Sedrak 博士在以患者为中心的老年肿瘤学研究方面的独立职业生涯。