Johns Hopkins School of Nursing, 525 N. Wolfe St, Baltimore, MD 21205-2110, USA.
Bloomberg School of Public Health, Baltimore, MD, USA.
J Racial Ethn Health Disparities. 2015 Jun;2(2):192-9. doi: 10.1007/s40615-014-0063-x.
Clinical trials are critical to advancing cancer treatment. Minority populations are underrepresented among trial participants, and there is limited understanding of their decision-making process and key determinants of decision outcomes regarding trial participation.
To understand research decision-making among clinical trial-eligible African-American cancer patients at Johns Hopkins, we conducted seven focus groups (n=32) with trial-offered patients ≥ 18 years diagnosed with lung, breast, prostate, or colorectal cancer ≤ 5 years. Three "acceptor" and four "decliner" focus groups were conducted. Questions addressed: attitudes towards clinical trials, reasons for accepting or declining participation, and recommendations to improve minority recruitment and enrollment. Data were transcribed and analyzed using traditional approaches to content and thematic analysis in NVivo 9.0. Data coding resulted in themes that supported model construction.
Participant experiences revealed the following themes when describing the decision-making process: Information gathering, Intrapersonal perspectives, and Interpersonal influences. Decision outcomes included the presence or absence of decision regret and satisfaction. From these themes, we generated a Model of Cancer Clinical Trial Decision-making.
Our model should be tested in hypothesis-driven research to elucidate factors and processes influencing decision balance and outcomes of trial-related decision-making. The model should also be tested in other disparities populations and for diagnoses other than cancer.
临床试验对于推进癌症治疗至关重要。少数族裔人群在试验参与者中代表性不足，对于他们参与试验的决策过程和关键决定因素的理解有限。
为了了解约翰霍普金斯大学符合条件的非洲裔美国癌症患者的研究决策，我们对 32 名年龄在 18 岁及以上、被诊断患有肺癌、乳腺癌、前列腺癌或结直肠癌且患病时间不超过 5 年的患者进行了 7 次焦点小组讨论。进行了 3 次“接受者”和 4 次“拒绝者”焦点小组。问题涉及：对临床试验的态度、参与或拒绝参与的原因，以及改善少数民族招募和参与的建议。使用 NVivo 9.0 中的传统内容分析和主题分析方法对转录数据进行分析。数据编码产生了支持模型构建的主题。
参与者在描述决策过程时的经验揭示了以下主题：信息收集、个人观点和人际影响。决策结果包括是否存在决策后悔和满意度。从这些主题中，我们生成了癌症临床试验决策模型。
我们的模型应在假设驱动的研究中进行测试，以阐明影响试验相关决策平衡和结果的因素和过程。该模型还应在其他差异人群和除癌症以外的诊断中进行测试。
