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.

摘要 在美国，超过70，000名青少年和年轻人（AYA）被诊断患有癌症。 只有不到10%的人参加了临床试验，这反映出其比例远低于儿童和老年人 成年人了然而，参加治疗性临床试验的癌症AYA患者的生存率和依从性都有所提高 长期的后续护理。此外，临床试验入组对于解决劣效 近几十年来，整个A-YA年龄组的生存率有所提高。 在老年人中的工作已经确定了临床上的种族，民族，地理和社会经济差异。 试验入组。与白人相比，黑人和西班牙裔成年人在临床试验中的代表性不足， 农村地区和低收入人群。以前的工作，以检查临床试验参与AYA 没有审查代表性不足的群体的审判观点，也没有审查代表性不足的群体面临的主要障碍。 他们参与治疗试验的方式。 这项拟议的研究将评估癌症AYA患者临床试验入组的差异 年龄在12-29岁之间，分布在3个州：路易斯安那州、新墨西哥州和田纳西州。所有三个州都是最高的 美国的贫困率，农村和城市地理的混合以及种族和民族的多样性 人口，包括大量的黑人和西班牙裔AYAs以及美国印第安人AYAs。我们将 重点关注AYA临床试验入组的三个关键障碍：试验可用性的结构性障碍， 访问，个人障碍，如财务问题和对试验的信念，以及人际关系障碍相关 患者、家属和肿瘤学家之间关于试验的交流。这些地区 在既往成人研究中确定为临床试验入组的可补救障碍，与以下方面特别相关： 种族、民族、地理和社会经济多样化的人口。我们的目标是： 目的1：评估AVA试验在3个不同州的可用性和可及性，包括种族差异， 种族、社会经济地位和地理位置。使用国家癌症登记数据和临床试验可用性 从ClinicalTrials.gov获得的数据，我们将确定可用的试验和试验访问受限的AYA人群。 目的2：确定癌症AYA试验入组的个体和人际障碍， 包括种族、民族、社会经济地位和地理位置的差异。我们将调查AYA， 癌症，护理人员和肿瘤学家检查参加试验的意愿;采访美国印第安人AYA， 确定试验观点;录音AYA-家庭-肿瘤学家讨论，以检查试验沟通。 影响：在本研究结束时，我们将确定关键的结构性、个人和人际障碍， 在3个州为A Y A进行临床试验，包括与种族，民族， 社会经济和地理上多样化的人口以及优先干预领域。我们的下一步 将制定适用于各种环境的有针对性的干预措施，以解决已查明的障碍。