Hyatt Amelia, Lipson-Smith Ruby, Gough Karla, Butow Phyllis, Jefford Michael, Hack Thomas F, Hale Sandra, Zucchi Emiliano, White Shane, Ozolins Uldis, Schofield Penelope
Department of Health Services Research and Implementation Science, Peter MacCallum Cancer Centre, Melbourne, Australia.
Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Contemp Clin Trials Commun. 2022 May 28;28:100932. doi: 10.1016/j.conctc.2022.100932. eCollection 2022 Aug.
Oncology patients who are migrants or refugees face worse outcomes due to language and communication barriers impacting care. Interventions such as consultation audio-recordings and question prompt lists may prove beneficial in mediating communication challenges. However, designing robust research inclusive of patients who do not speak English is challenging. This study therefore aimed to: a) pilot test and assess the appropriateness of the proposed research design and methods for engaging migrant populations, and b) determine whether a multi-site RCT efficacy assessment of the communication intervention utilising these methods is feasible.
This study is a mixed-methods parallel-group, randomised controlled feasibility pilot trial. Feasibility outcomes comprised assessment of: i) screening and recruitment processes, ii) design and procedures, and iii) research time and costing. The communication intervention comprised audio-recordings of a key medical consultation with an interpreter, and question prompt lists and cancer information translated into Arabic, Greek, Traditional, and Simplified Chinese.
Assessment of feasibility parameters revealed that despite barriers, methods utilised in this study supported the inclusion of migrant oncology patients in research. A future multi-site RCT efficacy assessment of the INFORM communication intervention using these methods is feasible if recommendations to strengthen screening and recruitment are adopted. Importantly, hiring of bilingual research assistants, and engagement with community and consumer advocates is essential. Early involvement of clinical and interpreting staff as key stakeholders is likewise recommended.
Results from this feasibility RCT help us better understand and overcome the challenges and misconceptions about including migrant patients in clinical research.
移民或难民身份的肿瘤患者由于语言和沟通障碍影响医疗护理，面临更差的治疗结果。诸如会诊录音和问题提示清单等干预措施可能有助于应对沟通挑战。然而，设计包含非英语患者的严谨研究具有挑战性。因此，本研究旨在：a）对拟议的研究设计和吸引移民群体参与的方法进行试点测试并评估其适用性，以及b）确定利用这些方法对沟通干预进行多中心随机对照试验疗效评估是否可行。
本研究是一项混合方法的平行组随机对照可行性试点试验。可行性结果包括对以下方面的评估：i）筛查和招募过程，ii）设计和程序，以及iii）研究时间和成本。沟通干预包括关键医疗会诊的带口译员的录音，以及翻译成阿拉伯语、希腊语、繁体中文和简体中文的问题提示清单和癌症信息。
可行性参数评估显示，尽管存在障碍，但本研究中使用的方法支持将移民肿瘤患者纳入研究。如果采纳加强筛查和招募的建议，未来使用这些方法对INFORM沟通干预进行多中心随机对照试验疗效评估是可行的。重要的是，雇佣双语研究助理以及与社区和消费者倡导者合作至关重要。同样建议临床和口译人员作为关键利益相关者尽早参与。
这项可行性随机对照试验的结果有助于我们更好地理解和克服在将移民患者纳入临床研究方面的挑战和误解。
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