Cook For Your Life: Maintaining diet and physical activity changes in Latina breast cancer survivors

描述（由申请人提供）：癌症幸存者有明确的饮食和身体活动指南：吃水果/蔬菜含量高，能量密度低的食物，每周进行150分钟的中度到剧烈的身体活动。然而，癌症幸存者几乎没有（如果有的话）资源来满足这些指南，并且有有限的数据支持癌症幸存者如何实现持续的饮食变化。少数癌症幸存者可获得的行为改变资源甚至更少。很少有研究探讨了在改变和保持健康行为的人的教育和电子通信策略的单独和协同作用。我们之前在讲西班牙语的拉丁裔乳腺癌幸存者中进行的R21试点研究表明，我们基于文化的9次会议（12周内24小时） 你好，帕拉！课程增加水果/蔬菜摄入量长达12个月，但没有减少膳食脂肪（R21 CA 152903）。一项缩短的4节课（4周16小时）课程的试点研究效果较差。因此，作为我们先前工作的延伸，我们将测试我们课程的修改版本，其中将包括减少食物中能量密度的新内容，增加体力活动，并将包括实践技能。 在每一个班级都建立烹饪组件。社会认知理论和跨理论模型将为干预提供框架。我们将招募200名讲西班牙语和英语的拉丁裔乳腺癌幸存者参加为期12个月的试验。本研究将采用2x2析因设计。所有参与者都将收到关于乳腺癌幸存者饮食和体力活动建议的书面材料，以及鼓励体力活动的计步器。参与者将被随机分配到单独的面对面教育（6个4小时的课程），单独的电子通信（激励性电子通讯加上互动网站），面对面教育加上电子通信或对照组。随机化将根据首选语言（英语vs.西班牙语）、绝经状态和当前使用的抗激素治疗进行分层。将在基线、6个月和12个月时进行门诊访视、采血和饮食评估。每月电话将收集简短的行为变化数据，并作为保留支持。主要目的是确定库克为你的生活的单独和协同效应！通过增加每日水果/蔬菜摄入量和减少12个月时的每日总能量密度来评估拉丁裔乳腺癌幸存者的干预措施。次要目的将1）检查干预对体力活动和体重减轻的影响; 2）检查饮食变化介质的预测因子; 3）检查干预对与乳腺癌复发风险相关的炎症和氧化应激生物标志物的影响。研究结果将确定在多样化和服务不足的癌症幸存者人群中进行干预的最佳交付方法。如果有效，可以通过社区团体和医疗中心实施标准化干预。研究结果将用于设计一项多中心试验，以测试行为干预对合并症、癌症复发和生存的长期影响。

DESCRIPTION (provided by applicant): There are clear diet and physical activity guidelines for cancer survivors: eat a diet high in fruits/vegetables and low in energy-dense foods and engage in 150 minutes of moderate-to-vigorous physical activity each week. However, cancer survivors are provided with few, if any, resources to meet these guidelines and there are limited data supporting how cancer survivors can achieve sustained dietary change. There are even fewer behavioral change resources available to minority cancer survivors. Few studies have examined the separate and synergistic effects of in-person education and e-communication strategies in changing and maintaining health behaviors. Our prior R21 pilot study among Spanish-speaking Latina breast cancer survivors showed that our culturally-based 9-session (24-hours over 12 weeks) ¡Cocinar Para Su Salud! Curriculum increased fruit/vegetable intake up to 12 months, but did not decrease dietary fat (R21CA152903). A pilot study of a shortened 4-session (16-hours over 4 weeks) curriculum was less effective. Therefore, as an extension of our prior work, we will test a modified version of our curriculum that will include new content on decreasing energy density in food, increasing physical activity, and will include a hands-on skills building cooking component in every class. Social cognitive theory and the Trans theoretical model will frame the intervention. We will recruit 200 female Spanish- and English-speaking Latina breast cancer survivors to participate in a 12-month trial. The study will use a 2x2 factorial design. All participants will receive written materials on diet and physical activity recommendations for breast cancer survivors and a pedometer to encourage physical activity. Participants will be randomized to in-person education alone (6 4-hour sessions), e-communication alone (motivational e-newsletters plus an interactive website), in-person education plus e-communication, or control. Randomization will be stratified on preferred language (English vs. Spanish), menopausal status and current use of anti-hormonal therapy. Clinic visits, blood collection and dietary assessment will occur at baseline, 6 and 12 months. Monthly telephone calls will collect brief behavior change data and serve as retention support. The Primary Aim is to determine the separate and synergistic effects of the Cook for Your Life! Intervention among Latina breast cancer survivors assessed via increase in daily servings of fruits/vegetables and decrease in total daily energy density at 12 months. Secondary Aims will 1) examine effects of the intervention on physical activity and weight loss; 2) examine predictors of mediators of dietary change; and 3) examine the effects of the intervention on biomarkers of inflammation and oxidative stress associated with breast cancer recurrence risk. Study results will determine the best delivery method for the intervention in a diverse and underserved population of cancer survivors. If effective, the standardized intervention can be implemented by community groups and medical centers. Study results will be used to design a multi-site trial to test the long- term effects of a behavioral intervention on comorbidities, cancer recurrence and survival.