“由于资源和教育可获得的乳房x光检查”（MADRE）研究：基本原理和设计。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-01 DOI:10.1016/j.cct.2024.107786

Sean P. McClellan , Elizabeth De La Paz , Juanita Arroyo , Silvia Montoya , Jocelyn Perez , Ezra Wright , Emely Moreno , Monica Padilla , Candyce H. Kroenke , Garth H. Rauscher , Erin Neuschler , Pamela Ganschow , Nathan Stackhouse , Marc Atkins , John J. Dziak , Jennifer Watling Neal , Araceli Lucio , Yamile Molina

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引用次数: 0

摘要

背景：拉丁美洲人患乳腺癌的比例过高，部分原因是他们较少接受符合指南的乳腺癌筛查。我们描述了一项研究的设计，以比较解决这一重要公共卫生问题的两种方法。设计/方法：我们正在进行一项为期5年的随机对照试验。通过联邦认证的保健中心网络和社区外展，我们从芝加哥招募了400名拉丁裔妇女，她们没有遵守美国预防服务工作组乳腺癌筛查指南。参与者按1:1的比例随机接受两种基于电话的干预（赋权、教育）中的一种，为期3周。这两种干预措施都提供了乳腺癌早期检测的信息。授权干预还教导参与者与家人和朋友分享乳腺癌筛查的信息，而教育干预则教育患者如何预防乳腺癌。非依从性拉丁参与者招募有资格进行乳腺癌筛查的家人和朋友作为网络成员参加研究。网络成员不参与干预。主要结果是在干预参与者和网络成员中进行初始（入组后的任何乳房x光检查）和重复（入组后每两年测量一次）乳腺癌筛查。此外，我们将使用多层次结构方程模型来评估干预措施影响的潜在中介。讨论：这项研究将为赋权方法的发展提供信息，以增加拉丁裔乳腺癌筛查的参与，并减少健康差距。NCT05841355。

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The “Mammograms Available Due to Resources and Education” (MADRE) Study: Rationale and Design

Background

Latinas suffer disproportionately from breast cancer, partially due to lower uptake of guideline-concordant breast cancer screening. We describe the design of a study to compare two approaches addressing this important public health problem.

Design/methods

We are conducting a 5-year randomized controlled trial. From a federally qualified health center network and through community outreach, we are recruiting 400 Latinas from Chicago who are non-adherent with United States Preventive Services Task Force breast cancer screening guidelines. Participants are randomized at a 1:1 ratio to receive one of two phone-based interventions (empowerment, education) administered across 3 weekly sessions. Both interventions provide information about breast cancer early detection. The empowerment intervention additionally teaches participants to share information about breast cancer screening with family and friends, while the education intervention educates patients about breast cancer prevention. Non-adherent Latina participants recruit family and friends eligible for breast cancer screening to take part in the study as network members. Network members do not participate in the intervention. Primary outcomes are initial (any mammogram post-enrollment) and repeat (measured at two-year intervals after enrollment) breast cancer screening among intervention participants and network members. Additionally, we will use multi-level structural equation models to assess potential mediators of the impact of the interventions.

Discussion

This study will inform the development of empowerment approaches to increase participation in breast cancers screening among Latinas and reduce health disparities. NCT05841355

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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.