Randomized controlled trial of Nuevo Amanecer: A peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer
Randomized controlled trial of Nuevo Amanecer: A peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer
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DOI：
10.1177/1740774514521906
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发表时间：
2014-04-01
期刊：
影响因子：
2.7
通讯作者：
Stewart, Anita L.
中科院分区：
文献类型：
--
作者：
Napoles, Anna M.;Santoyo-Olsson, Jasmine;Stewart, Anita L.
拉丁裔乳腺癌患者的症状和心理健康存在差异。目前还没有针对这一人群开发或测试有效的干预措施。目的：我们描述了基于社区的参与性研究方法，用于开发和实施Nuevo Amanecer项目，这是一项针对低收入西班牙语拉丁裔乳腺癌患者的文化量身定制的同伴交付的认知行为压力管理干预措施，以及在实施随机对照试验以在社区环境中测试该项目时的独特考虑。方法我们应用实施科学框架来描述用于开发和实施Nuevo Amanecer项目和试验的方法阶段，强调社区参与过程。在第一阶段，我们建立了项目基础设施：学术和社区共同主要调查员、社区合作伙伴、社区咨询委员会、指导委员会和资金。在第二阶段，我们确定了三个项目投入：形成性研究、社区最佳实践模型和在非拉丁裔人中测试的循证干预。在第三阶段，我们通过整合和调整来自三个来源的干预组件来创建新项目，对低识字率、西班牙语、文化因素、社区背景和人口需求进行调整。在第四阶段，我们通过培训现场工作人员（在社区工作的招聘人员和干预人员）、补偿现场工作人员和创建识别潜在参与者的系统，为项目和试验建立了社区能力。在第五阶段，我们实施并监控了该计划和试验。让社区合作伙伴参与所有阶段的工作，形成了一个适合新诊断的拉丁裔乳腺癌患者的新的、有文化特色的项目，并得到了社区和临床合作伙伴的接受和支持。以社区为基础的组织和癌症幸存者作为研究伙伴的参与，以及从社区雇用招聘人员和干预人员，对于在社区环境中成功实施至关重要。拥有文化和语言能力强、人际交往能力强的研究人员有助于实施。促进和维护社区合作伙伴之间的良好沟通是解决实现问题的必要条件。由于社区担心将女性分配到对照组，随机化是具有挑战性的。患者隐私法规以及需要在社区合作伙伴和临床站点之间建立广泛的联系，阻碍了最初的招聘。这些都是开发和实施项目的资源密集型过程，需要与低强度替代方案进行比较。结论让社区成员参与社区项目和试验的设计和实施，可以提高文化适应性和与社区背景的一致性。如果随机试验证明干预是有效的，它将填补以证据为基础的项目的空白，以解决西班牙语拉丁裔乳腺癌患者生活质量的种族差异。
BackgroundLatinas with breast cancer suffer symptom and psychosocial health disparities. Effective interventions have not been developed for or tested in this population.PurposeWe describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program, a culturally tailored, peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer, and unique considerations in implementing a randomized controlled trial to test the program in community settings.MethodsWe applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial, emphasizing community engagement processes.ResultsIn phase 1, we established project infrastructure: academic and community co-principal investigators, community partners, community advisory board, steering committee, and funding. In phase 2, we identified three program inputs: formative research, a community best-practices model, and an evidence-based intervention tested in non-Latinas. In phase 3, we created the new program by integrating and adapting intervention components from the three sources, making adaptations to accommodate low literacy, Spanish language, cultural factors, community context, and population needs. In phase 4, we built community capacity for the program and trial by training field staff (recruiters and interventionists embedded in community sites), compensating field staff, and creating a system for identifying potential participants. In phase 5, we implemented and monitored the program and trial. Engaging community partners in all phases has resulted in a new, culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners.Lessons learnedEngagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings. Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation. Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues. Randomization was challenging due to community concerns about assigning women to a control group. Patient privacy regulations and the need for extensive outreach to establish relationships between community partners and clinical sites hampered initial recruitment.LimitationsThese were resource-intensive processes to develop and implement the program that need to be compared to less-intensive alternatives.ConclusionEngaging community members in design and implementation of community-based programs and trials enhances cultural appropriateness and congruence with the community context. If the randomized trial demonstrates that the intervention is effective, it will fill a gap in evidence-based programs to address ethnic disparities in quality of life among Spanish-speaking Latinas with breast cancer.