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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
Trials ( IF 2.5 ) Pub Date : 2021-09-17 , DOI: 10.1186/s13063-021-05593-y
Lauren M Hamel 1 , David W Dougherty 2 , Seongho Kim 1 , Elisabeth I Heath 1 , Lorna Mabunda 1 , Eyouab Tadesse 3 , RaeAnn Hill 3 , Susan Eggly 1
Affiliation  

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

中文翻译:

DISCO App:一项随机对照试验的研究方案,以测试患者干预措施的有效性,以减少不同患者群体的癌症经济负担

财务毒性,即治疗费用的物质和心理负担,影响了 30-50% 的癌症患者,甚至那些拥有健康保险的人。治疗费用的负担会影响治疗依从性,并最终影响死亡率。财务毒性是一个健康公平问题,不成比例地影响少数种族/族裔、收入较低且年龄小于 65 岁的患者。建议对患者进行有关治疗费用的教育和患者与肿瘤科医生的费用讨论,作为解决财务毒性的方法;然而,研究表明成本讨论很少发生(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 ; 美国癌症协会癌症行动网络 2010)。我们的总体目标是通过可定制的教育和交流干预,即 DISCO 应用程序来解决财务毒性负担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 应用程序对来自所有年龄组的经济和种族/民族多样化的癌症患者群体结果的有效性。在密歇根州底特律市 NCI 指定的综合癌症中心诊断出患有乳腺癌、肺癌、结肠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 3)。所有干预患者(第 2 组和第 3 组)将在与他们的肿瘤科医生进行第二次互动之前收到 DISCO 应用程序,第 3 组的患者将获得干预助推器。DISCO 应用程序,在 iPad 上呈现,包括关于治疗费用、管理方法以及与肿瘤学家讨论这些费用的重要性的教育视频。患者输入社会人口统计信息(例如,就业、保险状况)并表明他们的财务问题。然后,他们会收到一份量身定制的问题清单,以考虑询问他们的肿瘤科医生。所有患者将与他们的肿瘤科医生视频记录最多两次互动,并在基线、记录互动后以及第二次互动后 1、3、6 和 12 个月完成测量。结果测量将评估成本讨论、沟通质量、治疗成本知识、治疗成本管理的自我效能、支持转介、短期和长期财务毒性以及治疗依从性。如果有效,这种干预将提高对治疗成本的认识和讨论,并减轻财务毒性的负担。它可能对受金融毒性影响不成比例的群体特别有帮助,有助于实现健康公平。ClinicalTrials.gov NCT04766190。2021 年 2 月 23 日注册
更新日期:2021-09-17
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