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: 9982167
• 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 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9982167
• 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; Oncology; 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; clinical trial enrollment; ethnic minority population; evidence base; experience; improved; innovation; older patient; 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.

项目摘要/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子和障碍 老年患者的入学率（> 70岁）患有癌症。该提案旨在解决 国家衰老研究所增加肿瘤学临床研究中纳入老年人。这很重要 因为70岁以上的四分之一的美国人一生将被诊断出患有癌症。从2018年到 2040年，癌症事件预计将对年龄> 70岁的个人增加88％。但是，要求这种不成比例 在癌症临床试验中，癌症对老年人的发病率和影响严重不足。到 确定增加老年人参与的手段，拟议的研究基于两个初步 研究的研究强调了我们对促进者的理解和临床试验障碍的关键差距 老年人患有癌症。尽管许多研究表明障碍是多方面的，但出现 从系统，身体，患者和/或护理人员因素的组合中，很少有研究前景 检查了患者和身体的肿瘤学临床试验入学率的促进者和障碍 观点，没有人探索了护理人员的障碍。为了解决这一差距，具体目的是： 目的1。描述老年人的特征（> 70岁）与癌症的癌症的特征 临床试验，并确定非注册的原因；和目标2。确定促进者和障碍 老年人的肿瘤学临床试验（年龄> 70岁）患者，护理人员和 物理观点。在AIM 1中，我们将对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临床试验筛查工具 计划，美国46个社区网站的财团。在AIM 2中，我们将对 希望城市和会员社区站点的40名老年患者（> 70岁）患有癌症（有20名患者 入学和20例未参加治疗性肿瘤学临床试验的患者。患者的护理人员和 肿瘤学家也将被招募。与每个利益相关者的定性半结构化访谈（患者， 护理人员或肿瘤科医生将进行探索障碍和促进者的入学人数。定量 将收集数据，以确定促进因子和障碍是否因患者特征而不同（即老年病 评估），护理人员特征（即护理人员负担）和肿瘤学家的特征。这项研究 将产生重大影响，因为它将为制定和测试策略提供一个路线图 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 通过简单地评估患者，护理人员和物理观点来偏离当前的研究。 最后，拟议的研究将提供成功的精神，培训和经验 启动Sedrak博士在面向患者的老年肿瘤研究领域的独立职业。