Disparities in Clinical Trial Enrollment among Adolescents and Young Adults with Cancer

青少年和年轻人癌症患者临床试验入组率的差异

• 批准号: 10657036
• 负责人: JENNIFER W MACK
• 金额: $ 67.33万
• 依托单位: DANA-FARBER CANCER INST
• 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/10657036
• 关键词: Address; Adherence; Adolescent; Adolescent and Young Adult; Adolescent and young adult cancer patients; Adult; American Indians; Area; Attention; Audiotape; Belief; Black race; Cancer Center; Caregivers; Caring; Child; Clinical Trials; Collaborations; Communication; Community Clinical Oncology Program; Data; Development; Diagnosis; Disparity; Elderly; Eligibility Determination; Enrollment; Ethnic Origin; Family; Family Caregiver; Family member; Geography; Goals; Hispanic; Income; Individual; Inferior; Intervention; Interview; Location; Longterm Follow-up; Louisiana; Low income; Malignant Neoplasms; New Mexico; Newly Diagnosed; Oncologist; Oncology; Patients; Population; Population Heterogeneity; Poverty; Process; Progress Review Group; Psychology; Race; Research; Research Priority; Rural; Site; Socioeconomic Status; Surveys; Tennessee; Therapeutic Clinical Trial; Therapeutic Trials; Underrepresented Populations; United States; Vulnerable Populations; Work; age group; aged; clinical trial enrollment; cost; data registry; data sharing; ethnic diversity; experience; health communication; health disparity; improved; interest; neoplasm registry; population based; programs; racial difference; racial disparity; racial diversity; rare cancer; rural area; socioeconomic disparity; socioeconomics; survivorship; trial enrollment; urban area; urban residence; willingness

ABSTRACT More than 70,000 adolescents and young adults (AYAs) are diagnosed with cancer in the United States (US) each year, and fewer than 10% enroll in clinical trials, reflecting far lower rates than seen in children and older adults. Yet AYAs with cancer who enroll in therapeutic clinical trials have improved survival and better adherence to long-term follow-up care during survivorship. In addition, clinical trial enrollment is essential to address inferior survival gains seen in recent decades for the A YA age group as a whole. Work in older adults has identified racial, ethnic, geographic, and socioeconomic disparities in clinical trial enrollment. Black and Hispanic adults are underrepresented in clinical trials relative to whites, as are patients in rural areas and with low incomes. Previous work to examine clinical trial participation among AYAs has failed to examine trial perspectives among underrepresented groups or the key barriers that stand in the way of their enrollment to therapeutic trials. The proposed study will evaluate disparities in enrollment to clinical trials among AYAs with cancer aged 12-29 years in 3 states: Louisiana, New Mexico, and Tennessee. All 3 states have among the highest poverty rates in the United States, with a mix of rural and urban geography and racially and ethnically diverse populations, including large numbers of Black and Hispanic AYAs as well as American Indian AYAs. We will focus on three key barriers to clinical trial enrollment among A YAs: structural barriers of trial availability and access, individual barriers such as financial concerns and beliefs about trials, and interpersonal barriers related to communication about trials between patients, family members, and oncologists. These areas have been identified in previous work in adults as remediable barriers to clinical trial enrollment with special relevance to racially, ethnically, geographically, and socioeconomically diverse populations. Our aims are: Aim 1: To assess AVA trial availability and access in 3 diverse states, including disparities by race, ethnicity, socioeconomic status, and geography. Using state cancer registry data and clinical trial availability data from ClinicalTrials.gov, we will identify available trials and AYA populations with limited trial access. Aim 2: To identify individual and interpersonal barriers to trial enrollment among AYAs with cancer, including differences by race, ethnicity, socioeconomic status, and geography. We will survey AYAs with cancer, caregivers, and oncologists to examine willingness to enroll in trials; interview American Indian AYAs to identify trial perspectives; and audiotape AYA-family-oncologist discussions to examine trial communication. Impact: At the end of this study, we will have identified key structural, individual, and interpersonal barriers to enrollment in clinical trials for A Y As in 3 states, including areas with special relevance to a racially, ethnically, socioeconomically, and geographically diverse population, and prioritized areas for intervention. Our next step will be the development of targeted interventions applicable across diverse settings to address identified barriers.

抽象的 在美国，超过70,000名青少年和年轻人（AYA）被诊断出患有癌症（美国） 每年，参加临床试验的入学量不到10％，反映出比儿童和年龄较大的率要低得多 成年人。然而，参加治疗临床试验的癌症的AYA有改善的生存率和更好的依从性 在生存期间长期随访。此外，临床试验入学对于解决劣等至关重要 近几十年来，整个A YA年龄段的生存成就。 老年人的工作确定了临床的种族，种族，地理和社会经济差异 试用招生。黑人和西班牙裔成年人在临床试验中相对于白人的代表不足， 农村地区的患者收入低。先前检查AYAS中临床试验参与的工作 未能研究代表性不足的群体或站在的主要障碍之间的审判观点 他们参加治疗试验的方式。 拟议的研究将评估AYA癌症临床试验的入学差异 在3个州的12-29岁年龄：路易斯安那州，新墨西哥州和田纳西州。所有三个州都有最高 美国的贫困率与农村和城市地理以及种族和种族多样化的混合 人口，包括大量的黑人和西班牙裔AYA以及美洲印第安人AYA。我们将 专注于YAS临床试验入学的三个关键障碍：试验可用性的结构性障碍和 访问，个人障碍，例如财务问题和对试验的信念，以及与人际障碍有关的 沟通有关患者，家庭成员和肿瘤学家之间的试验。这些领域已经 在成年人以前的工作中确定为临床试验入学率的可补救障碍，与 在种族，种族，地理和社会经济上多样化的人群。我们的目标是： 目标1：评估3个不同州的AVA试用可用性和访问权限，包括种族差距， 种族，社会经济地位和地理。使用州癌症注册表数据和临床试验可用性 来自ClinicalTrials.gov的数据，我们将确定可用试验和试验有限的AYA人群。 目的2：确定AYA癌症中试验入学率的个人和人际障碍， 包括种族，种族，社会经济地位和地理的差异。我们将与 癌症，看护人和肿瘤学家检查愿意参加试验的意愿；采访美洲印第安人Ayas 确定审判观点；和录音带AYA-户主学家讨论以检查审判交流。 影响：在本研究结束时，我们将确定关键的结构，个人和人际障碍 与3个州一样 从社会经济上和地理上多样化的人群以及优先区域进行干预领域。我们的下一步 将是针对各种环境中适用的目标干预措施的制定，以解决已确定的障碍。