Kunos Charles A, Massett Holly A, Galassi Annette, Walker Joan L, Good Marge J, Díaz Luis Báez, McCaskill-Stevens Worta
Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, United States.
Center for Global Health, National Cancer Institute, Bethesda, MD, United States.
Front Oncol. 2018 Apr 10;8:102. doi: 10.3389/fonc.2018.00102. eCollection 2018.
Women in the U.S. Commonwealth of Puerto Rico (PR) have a higher age-adjusted incidence rate for uterine cervix cancer than the U.S. mainland as well as substantial access and economic barriers to cancer care. The National Cancer Institute (NCI) funds a Minority/Underserved NCI Community Oncology Research Program in PR (PRNCORP) as part of a national network of community-based health-care systems to conduct multisite cancer clinical trials in diverse populations. Participation by the PRNCORP in NCI's uterine cervix cancer clinical trials, however, has remained limited. This study reports on the findings of an NCI site visit in PR to assess barriers impeding site activation and accrual to its sponsored gynecologic cancer clinical trials. Qualitative, semi-structured individual, and group interviews were conducted at six PRNCORP-affiliated locations to ascertain: long-term trial accrual objectives; key stakeholders in PR that address uterine cervix cancer care; key challenges or barriers to activating and to enrolling patients in NCI uterine cervix cancer treatment trials; and resources, policies, or procedures in place or needed on the island to support NCI-sponsored clinical trials. An NCI-sponsored uterine cervix cancer radiation-chemotherapy intervention clinical trial (NCT02466971), already activated on the island, served as a test case to identify relevant patient accrual and site barriers. The site visit identified five key barriers to accrual: (1) lack of central personnel to coordinate referrals for treatment plans, medical tests, and medical imaging across the island's clinical trial access points; (2) patient insurance coverage; (3) lack of a coordinated brachytherapy schedule at San Juan-centric service providers; (4) limited credentialed radiotherapy machines island-wide; and (5) too few radiology medical physicists tasked to credential trial-specified positron emission tomography scanners island-wide. PR offers a unique opportunity to study overarching and tactical strategies for improving accrual to NCI-sponsored gynecologic cancer clinical trials. Interview findings support adding and re-tasking personnel for coordinated trial-eligible patient referral, accrual, and treatment.
美国波多黎各联邦的女性宫颈癌年龄调整发病率高于美国本土,而且在癌症护理方面面临诸多获取途径和经济障碍。美国国立癌症研究所(NCI)资助了波多黎各的少数族裔/服务不足社区肿瘤学研究项目(PRNCORP),作为基于社区的医疗保健系统全国网络的一部分,在不同人群中开展多中心癌症临床试验。然而,PRNCORP参与NCI的宫颈癌临床试验的情况仍然有限。本研究报告了NCI对波多黎各进行实地考察的结果,以评估阻碍该机构启动并参与其赞助的妇科癌症临床试验的障碍。在六个与PRNCORP相关的地点进行了定性、半结构化的个人和小组访谈,以确定:长期试验入组目标;波多黎各应对宫颈癌护理的关键利益相关者;启动并让患者参与NCI宫颈癌治疗试验的关键挑战或障碍;以及该岛为支持NCI赞助的临床试验而现有的或需要的资源、政策或程序。在该岛已经启动的一项由NCI赞助的宫颈癌放化疗干预临床试验(NCT02466971)被用作一个测试案例,以确定相关的患者入组和地点障碍。实地考察确定了五个关键的入组障碍:(1)缺乏中央人员来协调全岛临床试验接入点的治疗计划、医学检查和医学影像转诊;(2)患者保险覆盖范围;(3)以圣胡安为中心的服务提供商缺乏协调一致的近距离放射治疗时间表;(4)全岛有资质的放射治疗机器有限;(5)负责全岛试验指定正电子发射断层扫描扫描仪资质认证的放射医学物理学家太少。波多黎各为研究提高NCI赞助的妇科癌症临床试验入组率的总体和战术策略提供了独特机会。访谈结果支持增加和重新分配人员,以协调符合试验条件的患者转诊、入组和治疗。