The “Latines Lideres En Salud (LaLiSa)” study: Rationale and design

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-09-13 DOI:10.1016/j.cct.2024.107689
Paola Torres , Carolina Bujanda , Juanita Arroyo , Araceli Lucio , Vivian Pan , Pamela Ganschow , Kristin Andersen , Celeste Charchalac-Zapeta , Marilyn Barragan , Erin Neuschler , Sage J. Kim , Zhengjia Chen , Michelle Martinez , Samantha Madrid , Nathan Stackhouse , Nicole M. Gastala , Sean McClellan , Yamilé Molina
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Abstract

Background

Latines suffer from breast cancer (BC), due to elevated biological and social determinants of health (SDOH) risks. This study compares the effects of different strategies on uptake of cancer genetic services, specifically hereditary cancer risk assessment, genetic counseling, and genetic testing, and risk-based BC care.

Design/methods

In Chicago, Illinois, Aim 1 participants are recruited from a federally qualified health center (FQHC) and community venues. For Aim 1, eligible participants: (1) are female; (2) are Latine; (3) are 30+ years old; (4) have personal or family history of BC or cancers with shared hereditary mutations; (5) have at least one SDOH risk; and (6) have not received any cancer genetic services. Participants are randomly assigned to different study arms. Both arms include phone-based sessions, FQHC-based navigation for SDOH, and low- or no-cost cancer genetic services. The educate sessions focus on risk assessment and prevention. The empower sessions focus on risk assessment and equip participants with the skills to share information about FQHC-based cancer genetic services. For Aim 2, eligible participants are: (1) female; (2) network members of Aim 1 participants; and (3) eligible for BC screening based on guidelines recommended by the American Cancer Society (ACS). Primary outcomes include uptake of any cancer genetic services. Analyses will also explore intervention differences by neighborhood context.

Discussion

This is one of the first trials focused on Latines' participation in cancer genetic services and risk-based BC care within the context of SDOH - which has major implications for equity in precision cancer prevention.

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Latines Lideres En Salud (LaLiSa) "研究:理由和设计
背景拉丁美洲人罹患乳腺癌(BC)的原因是生物和社会健康决定因素(SDOH)风险升高。本研究比较了不同策略对接受癌症遗传服务(特别是遗传性癌症风险评估、遗传咨询和基因检测)和基于风险的乳腺癌护理的影响。设计/方法在伊利诺斯州芝加哥,从联邦合格医疗中心(FQHC)和社区场所招募目标 1 的参与者。目标 1 的合格参与者包括:(1)女性;(2)拉丁裔;(3)30 岁以上;(4)有 BC 个人或家族病史或有共同遗传突变的癌症;(5)至少有一种 SDOH 风险;(6)未接受过任何癌症遗传服务。参与者被随机分配到不同的研究组。两个研究组都包括电话会议、基于 FQHC 的 SDOH 导航以及低成本或免费的癌症基因服务。教育课程侧重于风险评估和预防。授权课程侧重于风险评估,并使参与者掌握分享基于 FQHC 的癌症基因服务信息的技能。对于目标 2,符合条件的参与者必须是(1) 女性;(2) 目标 1 参与者的网络成员;(3) 符合美国癌症协会 (ACS) 推荐的 BC 筛查指南。主要结果包括接受任何癌症基因服务。讨论这是首批在 SDOH 背景下关注拉丁裔参与癌症基因服务和基于风险的 BC 护理的试验之一,对癌症精准预防的公平性具有重要意义。
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来源期刊
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.
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