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比较高和低招募社区诊所青少年和青年临床试验入组的障碍和促进因素。

Comparing Barriers and Facilitators to Adolescent and Young Adult Clinical Trial Enrollment Across High- and Low-Enrolling Community-Based Clinics.

机构信息

Institute of Health System Science, Northwell Health, Manhasset, NY, USA.

Cancer Prevention Fellowship Program, Division of Cancer Prevention, National Cancer Institute, Rockville, MD, USA.

出版信息

Oncologist. 2022 May 6;27(5):363-370. doi: 10.1093/oncolo/oyac030.

Abstract

BACKGROUND

Adolescent and young adult (AYA) patients with cancer are underrepresented on cancer clinical trials (CCTs), and most AYAs are treated in the community setting. Past research has focused on individual academic institutions, but factors impacting enrollment vary across institutions. Therefore, we examined the patterns of barriers and facilitators between high- and low-AYA enrolling community-based clinics to identify targets for intervention.

MATERIALS AND METHODS

We conducted 34 semi-structured interviews with stakeholders employed used at National Cancer Institute Community Oncology Research Program (NCORP) affiliate sites ("clinics"). Stakeholders (eg, clinical research associates, patient advocates) were recruited from high- and low-AYA enrolling clinics. We conducted a content analysis and calculated the percentage of stakeholders from each clinic type that reported the barrier or facilitator. A 10% gap between high- and low-enrollers was considered the threshold for differences.

RESULTS

Both high- and low-enrollers highlighted insufficient resources as a barrier and the presence of a patient eligibility screening process as a facilitator to AYA enrollment. High-enrolling clinics reported physician gatekeeping as a barrier and the improvement of departmental collaboration as a facilitator. Low-enrollers reported AYAs' uncertainty regarding the CCT process as a barrier and the need for increased physician endorsement of CCTs as a facilitator.

CONCLUSIONS

High-enrolling clinics reported more barriers downstream in the enrollment process, such as physician gatekeeping. In contrast, low-enrolling clinics struggled with the earlier steps in the CCT enrollment process, such as identifying eligible trials. These findings highlight the need for multi-level, tailored interventions rather than a "one-size-fits-all" approach to improve AYA enrollment in the community setting.

摘要

背景

癌症青少年和年轻成人(AYA)患者在癌症临床试验(CCT)中的代表性不足,大多数 AYA 患者在社区环境中接受治疗。过去的研究集中在个别学术机构,但影响入组的因素因机构而异。因此,我们研究了高和低 AYA 入组社区为基础的诊所之间的障碍和促进因素模式,以确定干预的目标。

材料和方法

我们对在国家癌症研究所社区肿瘤学研究计划(NCORP)附属机构(“诊所”)工作的利益相关者进行了 34 次半结构化访谈。利益相关者(例如临床研究助理、患者倡导者)是从高和低 AYA 入组诊所招募的。我们进行了内容分析,并计算了报告障碍或促进因素的每个诊所类型的利益相关者的百分比。高和低入组者之间 10%的差距被认为是差异的阈值。

结果

高和低入组者都强调资源不足是一个障碍,并且存在患者资格筛选过程是促进 AYA 入组的因素。高入组诊所报告医生把关是一个障碍,改善部门合作是一个促进因素。低入组诊所报告 AYA 对 CCT 过程的不确定性是一个障碍,需要增加医生对 CCT 的认可作为一个促进因素。

结论

高入组诊所报告了更多的障碍,如医生把关,这是入组过程中的下游障碍。相比之下,低入组诊所在 CCT 入组过程的早期阶段遇到了困难,例如确定合格的试验。这些发现强调需要采取多层次、量身定制的干预措施,而不是一刀切的方法,以提高社区环境中 AYA 的入组率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e46/9074986/d71dbeff9a19/oyac030f0001.jpg

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