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

描述(申请人提供)：为癌症幸存者提供了明确的饮食和体力活动指南：饮食中水果/蔬菜含量高，高能量食物含量低，每周进行150分钟中等到剧烈的体力活动。然而，癌症幸存者几乎没有资源来满足这些指南，而且支持癌症幸存者如何实现可持续饮食改变的数据有限。为少数族裔癌症幸存者提供的行为改变资源甚至更少。很少有研究考察面对面教育和电子沟通策略在改变和维持健康行为方面的单独和协同效应。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24小时) “Cocina Para Su Salud！课程增加了12个月的水果/蔬菜摄入量，但没有减少膳食脂肪(R21CA152903)。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，其中将包括降低食物中的能量密度、增加体力活动的新内容，并将包括动手技能 在每个班级中构建烹饪组件。社会认知理论和迁移理论模型将构成干预的框架。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。这项研究将采用2x2析因设计。所有参与者都将收到有关乳腺癌幸存者的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。参与者将被随机分为单独的面授教育(6个4小时的课程)、单独的电子交流(激励性的电子通讯加上一个互动网站)、面授教育+电子交流或对照。随机化将根据首选语言(英语与西班牙语)、更年期状态和当前抗激素治疗的使用情况进行分层。将在基线、6个月和12个月时进行诊所就诊、采血和饮食评估。每月的电话将收集简短的行为改变数据，并作为留住支持。主要目标是确定厨师对你的生活的单独和协同影响！对拉丁裔乳腺癌幸存者的干预通过12个月后每日水果/蔬菜摄入量的增加和每日总能量密度的下降来评估。次要目标将1)检查干预对体力活动和减肥的影响；2)检查饮食变化中介的预测因素；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记物的影响。研究结果将确定在多样化和服务不足的癌症幸存者群体中进行干预的最佳交付方法。如果有效，标准化干预可以由社区团体和医疗中心实施。研究结果将被用于设计一项多点试验，以测试行为干预对合并症、癌症复发和存活率的长期影响。

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.