Using a SMART design to evaluate remotely delivered, culturally tailored weight loss interventions among Latina breast cancer survivors

项目摘要/摘要 乳腺癌(BC)是美国拉丁裔癌症死亡的主要原因。拉美裔人肥胖的风险很高 以及与肥胖相关的疾病，这些疾病与较差的癌症预后有关。这是一个严重缺乏的 一种有效的干预措施，以满足不列颠哥伦比亚州拉丁裔幸存者实现健康体重的不同需求。我们 开发并测试了多组分减肥、饮食改变和体力活动(PA) 对不列颠哥伦比亚省幸存者的干预，重点是拉丁裔的体验式学习(EL)。作为下一步， 我们提出了一种序贯多分配随机试验(SMART)测试12个月的文化适应性- 在一组地理位置不同的不列颠哥伦比亚州拉丁裔幸存者中进行了量身定制的减肥干预。自适应的 干预措施将使用疾控中心的糖尿病预防计划(DPP)，这是一个基于证据的减肥计划， 作为教育的中心组成部分。在前期工作的基础上，我们将对民进党进行远程适配 提供，包括公元前幸存者特有的信息，并为拉丁裔量身定做文化。女性将会成为 通过3个西海岸SEER注册招募。纳入标准：5年内诊断为I-III BC期，无 复发性疾病的证据，治疗后60天，体重指数(BMI)为30公斤/平方米。基线，1，3， 6个月和12个月的评估将包括关于病史、饮食和患者报告的问卷 心理社会/生活质量结果；客观测量的体重；加速度计测量的PA；和干燥 血液斑点，以测量炎症/心脏代谢生物标志物。对以下部分进行了定性访谈 参与者将在1个月和12个月时进行。12个月的目标…维达！(生活！)方案就是要实现 体重减轻了7%。在基线评估之后，参与者(n=410)将被随机分配到VIDA！或者“VIDA！+ 艾尔。在1个月后，应答者(体重减轻2%)将继续他们的干预，而非应答者(&lt；2%)将继续接受干预 体重减轻)将被重新随机化以接受增强的行为支持(即，EL的组合， 个性化的健康指导，并提供食品杂货)。目的1)比较四种适应症的有效性 拉丁裔BC幸存者的减肥干预措施，以“VIDA！或VIDA！+EL(阶段1)，后跟 为无反应者增加了11个月的行为支持(阶段2)。目标2)使用新颖的数据驱动 确定关键的个体基线特征是否缓和自适应的影响的方法 干预减肥，从而为更个性化的适应性减肥奠定基础 战略。探索性目标I)评估干预参与度是否缓和了 关于减肥的适应性干预措施；二)比较适应性干预措施对 炎症和心脏代谢生物标志物、饮食质量和PA；iii)定量评估生物心理社会 行为改变的预测者/中介者；以及iv)定性地评估参与者的体验以理解 影响研究结果的因素。这场审判将产生证据，证明 有效的、可扩展的减肥计划，以促进拉美裔BC幸存者的健康癌症存活率。

PROJECT SUMMARY / ABSTRACT Breast cancer (BC) is the leading cause of cancer death among US Latinas. Latinas are at high risk of obesity and obesity-related diseases, which are associated with poorer cancer outcomes. There is a significant lack of an effective intervention to address the diverse needs of Latina BC survivors to achieve a healthy weight. We have developed and tested multi-component weight loss, dietary change, and physical activity (PA) interventions among BC survivors, with a focus on experiential learning (EL) among Latinas. As the next step, we propose a sequential multiple assignment randomized trial (SMART) testing 12 month adaptive culturally- tailored weight loss interventions in a geographically diverse group of Latina BC survivors. The adaptive interventions will use the CDC’s Diabetes Prevention Program (DPP), an evidence-based weight loss program, as the central educational component. Based on our prior work, we will adapt the DPP to be remotely delivered, include information specific to BC survivors, and be culturally-tailored to Latinas. Women will be recruited via 3 West Coast SEER registries. Inclusion criteria: Diagnosis of stage I-III BC within 5 years, no evidence of recurrent disease, >60 days post-treatment, and body mass index (BMI) 30 kg/m2. Baseline, 1, 3, 6, and 12 month assessments will include questionnaires on medical history, diet, and patient-reported psychosocial/quality of life outcomes; objectively measured weight; accelerometer measured PA; and dried blood spots to measure inflammatory/cardiometabolic biomarkers. Qualitative interviews with a subset of participants will take place at 1 and 12 months. The goal of the 12 month ¡Vida! (Life!) program is to achieve 7% weight loss. Following baseline assessments, participants (n=410) will be randomized to ¡Vida! or ¡Vida! + EL. At 1 month, responders (2% weight loss) will continue with their intervention and non-responders (<2% weight loss) will be re-randomized to receive augmented behavioral support (i.e., combinations of EL, individualized health coaching, and delivered groceries). Aim 1) To compare the effectiveness of four adaptive interventions for weight loss in Latina BC survivors, beginning with ¡Vida! or ¡Vida! + EL (Stage 1) followed by augmented behavioral support for 11 months for non-responders (Stage 2). Aim 2) To use a novel data-driven approach to determine whether key individual baseline characteristics moderate the effect of the adaptive interventions on weight loss, and thus lay the groundwork for more personalized adaptive weight loss strategies. Exploratory Aims will i) assess whether intervention engagement moderates the effect of the adaptive interventions on weight loss; ii) compare the effects of adaptive interventions on changes in inflammatory and cardiometabolic biomarkers, diet quality, and PA; iii) quantitatively assess biopsychosocial predictors/mediators of behavior change; and iv) qualitatively assess the participant experience to understand factors that contribute to study outcomes. The trial will generate evidence on the best strategies for an effective, scalable weight loss program to promote healthy cancer survivorship among Latina BC survivors.