Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, Seattle, WA.
Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA.
JCO Oncol Pract. 2021 Nov;17(11):e1821-e1829. doi: 10.1200/OP.20.00770. Epub 2021 Apr 2.
Biomarker-driven master protocols represent a new paradigm in oncology clinical trials, but their complex designs and wide-ranging genomic results returned can be difficult to communicate to participants. The objective of this pilot study was to evaluate patient knowledge and expectations related to return of genomic results in the Lung Cancer Master Protocol (Lung-MAP).
Eligible participants with previously treated advanced non-small-cell lung cancer were recruited from patients enrolled in Lung-MAP. Participants completed a 38-item telephone survey ≤ 30 days from Lung-MAP consent. The survey assessed understanding about the benefits and risks of Lung-MAP participation and knowledge of the potential uses of somatic testing results returned. Descriptive statistics and odds ratios for associations between demographic factors and correct responses to survey items were assessed.
From August 1, 2017, to June 30, 2019, we recruited 207 participants with a median age of 67, 57.3% male, and 94.2% White. Most participants "strongly/somewhat agreed" with statements that they "received enough information to understand" Lung-MAP benefits (82.6%) and risks (69.5%). In items asking about potential uses of Lung-MAP genomic results, 87.0% correctly indicated that the results help to select cancer treatment, but < 20% correctly indicated that the results are not used to confirm cancer diagnosis, would not reveal risk of developing diseases besides cancer, and would not indicate if family members had increased cancer risk. There were no associations between sociodemographic factors and proportions providing correct responses.
In a large National Clinical Trials Network biomarker-driven master protocol, most participants demonstrated incorrect knowledge and expectations about the uses of genomic results provided in the study despite most indicating that they had enough information to understand benefits and risks.
生物标志物驱动的主方案代表了肿瘤临床试验的一种新范例，但它们复杂的设计和广泛的基因组结果可能难以向参与者传达。本研究的目的是评估肺癌主方案（Lung-MAP）中返回基因组结果相关的患者知识和期望。
从参与 Lung-MAP 的患者中招募了先前接受过治疗的晚期非小细胞肺癌合格参与者。参与者在签署 Lung-MAP 同意书后≤30 天内完成了一项 38 项的电话调查。该调查评估了对参与 Lung-MAP 的获益和风险的理解，以及对返回的体细胞检测结果的潜在用途的了解。评估了人口统计学因素与调查项目正确回答之间的关联的描述性统计和比值比。
从 2017 年 8 月 1 日至 2019 年 6 月 30 日，我们招募了 207 名中位年龄为 67 岁的参与者，其中 57.3%为男性，94.2%为白人。大多数参与者“强烈/有些同意”他们“获得了足够的信息来理解”Lung-MAP 的获益（82.6%）和风险（69.5%）的说法。在询问 Lung-MAP 基因组结果的潜在用途的项目中，87.0%的人正确地指出，结果有助于选择癌症治疗，但<20%的人正确地指出，结果不用于确认癌症诊断，不会揭示除癌症以外的疾病的风险，也不会表明家庭成员是否有增加的癌症风险。社会人口统计学因素与提供正确回答的比例之间没有关联。
在一项大型国家临床试验网络的生物标志物驱动的主方案中，尽管大多数参与者表示他们有足够的信息来理解获益和风险，但大多数参与者对研究中提供的基因组结果的用途表现出不正确的知识和期望。
