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基于社会人口统计学和疾病特征研究癌症临床试验参与机会和资格的差异。

Examining Differences in Opportunity and Eligibility for Cancer Clinical Trial Participation Based on Sociodemographic and Disease Characteristics.

作者信息

Rearden Jessica, Hanlon Alexandra L, Ulrich Connie, Brooks-Carthon Margo, Sommers Marilyn

机构信息

University of Pennsylvania in Philadelphia.

School of Nursing, University of Pennsylvania, Philadelphia.

出版信息

Oncol Nurs Forum. 2016 Jan;43(1):57-66. doi: 10.1188/16.ONF.57-66.

Abstract

PURPOSE/OBJECTIVES: To examine differences in opportunity and eligibility for cancer clinical trial (CCT) participation based on sociodemographic and disease characteristics.
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DESIGN: A matched cross-sectional study including a prospective oral questionnaire and retrospective electronic medical record (EMR) review.
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SETTING: A single hospital in a large academic National Cancer Institute-designated cancer center in Philadelphia, Pennsylvania.
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SAMPLE: 44 Black or Hispanic and 44 Non-Hispanic White newly diagnosed individuals matched on cancer type and age (plus or minus five years).
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METHODS: Participants answered a questionnaire to capture self-reported opportunity for CCT participation, sociodemographic information, and cancer type. With consent, the authors completed a retrospective review of the EMR to assess eligibility and collect cancer stage and performance status.
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MAIN RESEARCH VARIABLES: Opportunity and eligibility for CCT participation.
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FINDINGS: Most participants (78%) had no opportunity for participation and were ineligible for all available trials. No differences were noted in opportunity for participation or eligibility based on race or ethnicity. Participants with late-stage disease were more likely to have opportunity and be eligible for CCT participation (p = 0.001). Those with private insurance were less likely to have opportunity for participation (p = 0.05).
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CONCLUSIONS: Limited trial availability and ineligibility negatively influenced opportunity for CCT participation for all populations. Levels of under-representation for CCT participation likely vary within and across sociodemographic and disease characteristics, as well as across healthcare settings.
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IMPLICATIONS FOR NURSING

The unique roles of nurse navigators and advanced practice nurses can be leveraged to increase opportunities for CCT participation for all populations.

摘要

目的/目标:基于社会人口统计学和疾病特征,研究参与癌症临床试验(CCT)的机会和资格差异。

设计

一项匹配的横断面研究,包括前瞻性口头问卷调查和回顾性电子病历(EMR)审查。

地点

宾夕法尼亚州费城一家大型学术性国家癌症研究所指定癌症中心的单一医院。

样本

44名黑人或西班牙裔以及44名非西班牙裔白人新诊断个体,根据癌症类型和年龄(上下五岁)进行匹配。

方法

参与者回答一份问卷,以获取自我报告的参与CCT的机会、社会人口统计学信息和癌症类型。经同意,作者对电子病历进行回顾性审查,以评估资格并收集癌症分期和体能状态。

主要研究变量

参与CCT的机会和资格。

结果

大多数参与者(78%)没有参与机会,且不符合所有可用试验的条件。基于种族或民族,在参与机会或资格方面未发现差异。晚期疾病患者更有可能有机会参与CCT且符合条件(p = 0.001)。有私人保险的人参与机会较少(p = 0.05)。

结论

试验可用性有限和不符合条件对所有人群参与CCT的机会产生了负面影响。CCT参与的代表性不足水平可能因社会人口统计学和疾病特征以及医疗环境而异。

对护理的启示

可以利用护士导航员和高级实践护士的独特作用,增加所有人群参与CCT的机会。

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