基于智能手机的应用程序支持非裔美国男性在家进行前列腺特异抗原（PSA）筛查和针对其文化背景的前列腺癌教育的试点随机临床试验：研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-11-10 DOI:10.1016/j.cct.2024.107737

Jordan Neil , Bingjing Mao , Ruosi Shao , Motolani E. Ogunsanya , Summer Frank-Pearce , Michael Businelle , Michael Cookson , Kelly Stratton , Mark Doescher , Stephanie Pharr , Valerie Moise , Brianna Fleshman , Jack Fronheiser , Kimberly Estrada , Iván Flores , David Bradley , Ashley Kendrick , Adam C. Alexander

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引用次数: 0

摘要

背景：前列腺癌是美国黑人/非洲裔男性（AA）中确诊率最高的癌症，也是癌症相关死亡的第二大原因。前列腺特异性抗原（PSA）血液检测是前列腺癌的早期检测筛查工具，但 AA 族男性中接受 PSA 筛查的比例仍然很低。提高非裔男性的 PSA 筛查率，再加上早期治疗，可以减少前列腺癌结果（包括死亡率）的差异。目前的试点研究将测试首款移动医疗（mHealth）应用程序，以提高AA族男性对前列腺癌的认识，并增加采用家庭筛查方法的PSA筛查率：方法：年龄在 55 岁至 69 岁之间、尚未进行 PSA 筛查的 AA 族男性将按 1:1 的比例随机分配接受前列腺癌筛查应用程序：结果：我们将评估前列腺癌筛查应用程序的初步效果：我们将通过经过验证的 18 项前列腺癌知识量表（主要结果）的干预后组间差异来评估应用程序的初步效果。我们还将探讨干预后各组在应用的参与感、可及性和可接受性方面的差异。最后，我们将得出不同研究条件下 PSA 筛查率的初步估计值，并确定筛查坚持率的机制。讨论：移动医疗应用程序有望提高 AA 族男性的前列腺癌知识水平和筛查率。展示 Genius 应用程序的初步疗效将为未来解决健康差异问题的全功能移动医疗干预措施提供支持。

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A pilot randomized clinical trial of a smartphone-based application to support at-home PSA screening and culturally tailored prostate cancer education for African American men: A study protocol

Background

Prostate cancer is the most diagnosed cancer in Black/African American men (AA) and the second‑leading cause of cancer-related deaths. A prostate-specific antigen (PSA) blood test is an early detection screening tool for prostate cancer, but uptake of PSA screening remains low among AA men. Greater PSA screening rates among AA men, coupled with earlier treatment, may reduce disparities in prostate cancer outcomes, including mortality. The current pilot study will test the first-of-its-kind mobile health (mHealth) app to improve prostate cancer knowledge and increase PSA screening uptake among AA men using home-based screening methods.

Methods

AA men aged 55 to 69 and are not up to date with PSA screening will be randomly assigned 1:1 to receive a prostate cancer screening app: Prevention Taskforce App (Taskforce App; control condition) or the Prostate Cancer Genius App (Genius App; intervention condition), which was developed specifically for AA men.

Results

We will evaluate the preliminary efficacy of the apps via post-intervention group differences on the validated 18-item Prostate Cancer Knowledge Scale (primary outcome). We will also explore post-intervention group differences in perceived engagement, accessibility, and acceptability between the apps. Finally, we will derive preliminary estimates of PSA screening rates between study conditions and identify mechanisms of screening adherence.

Discussion

mHealth apps offer promise to improve prostate cancer knowledge and screening rates among AA men. Demonstrating the preliminary efficacy of the Genius App will support future fully-powered mHealth interventions to address health disparities.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.