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DISCO 应用程序:一项随机对照试验的研究方案,旨在测试一种患者干预措施在不同患者群体中降低癌症经济负担的有效性。

DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population.

机构信息

Wayne State University School of Medicine/Karmanos Cancer Institute, 4100 John R St., Detroit, MI, 48201, USA.

Dana-Farber Cancer Institute, Boston, MA, USA.

出版信息

Trials. 2021 Sep 17;22(1):636. doi: 10.1186/s13063-021-05593-y.

Abstract

BACKGROUND

Financial toxicity, the material and psychological burden of the cost of treatment, affects 30-50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adherence and, ultimately, mortality. Financial toxicity is a health equity issue, disproportionately affecting patients who are racial/ethnic minorities, have lower incomes, and are < 65 years old. Patient education about treatment cost and patient-oncologist cost discussions are recommended as ways to address financial toxicity; however, research shows cost discussions occur infrequently (Altice et al. J Natl Cancer Inst 109:djw205, 2017; Schnipper et al. J Clin Oncol 34:2925-34, 2016; Zafar et al. Oncologist 18:381-90, 2013; American Cancer Society Cancer Action Network 2010). Our overall goal is to address the burden of financial toxicity and work toward health equity through a tailorable education and communication intervention, the DISCO App. The aim of this longitudinal randomized controlled trial is to test the effectiveness of the DISCO App on the outcomes in a population of economically and racially/ethnically diverse cancer patients from all age groups.

METHODS

Patients diagnosed with breast, lung, colorectal, or prostate cancer at a NCI-designated comprehensive cancer center in Detroit, MI, will be randomized to one of three study arms: one usual care arm (arm 1) and two intervention arms (arms 2 and 3). All intervention patients (arms 2 and 3) will receive the DISCO App before the second interaction with their oncologist, and patients in arm 3 will receive an intervention booster. The DISCO App, presented on an iPad, includes an educational video about treatment costs, ways to manage them, and the importance of discussing them with oncologists. Patients enter socio-demographic information (e.g., employment, insurance status) and indicate their financial concerns. They then receive a tailored list of questions to consider asking their oncologist. All patients will have up to two interactions with their oncologist video recorded and complete measures at baseline, after the recorded interactions and at 1, 3, 6, and 12 months after the second interaction. Outcome measures will assess discussions of cost, communication quality, knowledge of treatment costs, self-efficacy for treatment cost management, referrals for support, short- and longer-term financial toxicity, and treatment adherence.

DISCUSSION

If effective, this intervention will improve awareness of and discussions of treatment cost and alleviate the burden of financial toxicity. It may be especially helpful to groups disproportionately affected by financial toxicity, helping to achieve health equity.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04766190. Registered on February 23, 2021.

摘要

背景

经济毒性是指治疗费用的物质和心理负担,影响 30-50%的癌症患者,即使他们有医疗保险。治疗费用的负担会影响治疗依从性,最终影响死亡率。经济毒性是一个健康公平问题,不成比例地影响到种族/少数民族、收入较低和年龄<65 岁的患者。建议通过患者教育了解治疗费用和医患讨论治疗费用来解决经济毒性问题;然而,研究表明,这种讨论很少发生(Altice 等人,J Natl Cancer Inst 109:djw205, 2017;Schnipper 等人,J Clin Oncol 34:2925-34, 2016;Zafar 等人,Oncologist 18:381-90, 2013;美国癌症协会癌症行动网络 2010)。我们的总体目标是通过一个可定制的教育和沟通干预措施——DISCO 应用程序来解决经济毒性负担问题,并努力实现健康公平。这项纵向随机对照试验的目的是测试 DISCO 应用程序在来自不同种族/民族和不同年龄段的经济困难的癌症患者人群中的效果。

方法

在密歇根州底特律的一个 NCI 指定的综合性癌症中心被诊断患有乳腺癌、肺癌、结直肠癌或前列腺癌的患者将被随机分配到三个研究组之一:一个常规护理组(第 1 组)和两个干预组(第 2 组和第 3 组)。所有干预组(第 2 组和第 3 组)的患者将在与肿瘤医生进行第二次互动之前使用 DISCO 应用程序,而第 3 组的患者将接受干预强化剂。DISCO 应用程序在 iPad 上呈现,包括一个关于治疗费用的教育视频,以及管理这些费用的方法,以及与肿瘤医生讨论这些费用的重要性。患者输入社会人口统计学信息(如就业、保险状况)并表示他们的财务担忧。然后,他们会收到一份考虑向肿瘤医生询问的问题的定制清单。所有患者将有最多两次与肿瘤医生的互动被录制下来,并在基线、记录后的互动以及第二次互动后的 1、3、6 和 12 个月完成测量。结果测量将评估费用讨论、沟通质量、治疗费用知识、治疗费用管理自我效能、转介支持、短期和长期财务毒性以及治疗依从性。

讨论

如果有效,这种干预措施将提高对治疗费用的认识和讨论,并减轻经济毒性的负担。它可能对受经济毒性不成比例影响的群体特别有帮助,有助于实现健康公平。

试验注册

ClinicalTrials.gov NCT04766190。于 2021 年 2 月 23 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da98/8447769/283c42435b53/13063_2021_5593_Fig1_HTML.jpg

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