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

使用 SMART 设计评估针对拉丁裔乳腺癌幸存者的远程实施、根据文化定制的减肥干预措施

• 批准号: 10587753
• 负责人: Heather Greenlee
• 金额: $ 74.8万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10587753
• 关键词: Accelerometer; Active Learning; Address; Aftercare; Area; Behavior Therapy; Behavioral; Biological Markers; Blood; Body Weight decreased; Body mass index; Breast Cancer survivor; C-reactive protein; Cancer Etiology; Cancer Survivor; Cancer Survivorship; Cause of Death; Cessation of life; Characteristics; Cholesterol; County; Data; Data Collection; Devices; Diabetes Mellitus; Diagnosis; Diet; Disease; Dryness; Education; Equity; Geography; Glucose; Glycosylated hemoglobin A; Goals; Health; Home; Individual; Inequity; Inflammatory; Intervention; Interview; Latina; Latina Population; Latino Population; Life; Los Angeles; Malignant Neoplasms; Measures; Mediator; Medical History; Mental Depression; Morbidity - disease rate; Obesity; Obesity associated disease; Outcome; Outcome Study; Overweight; Participant; Patients; Persons; Physical activity; Population; Population Heterogeneity; Quality of life; Questionnaires; Randomized; Recurrent disease; Registries; Reporting; Research; Resources; Sampling; Sequential Multiple Assignment Randomized Trial; Spottings; Stress; Structure; Survivors; Technology; Telephone; Testing; Triglycerides; Washington; Weight; Weights and Measures; Woman; Work; adaptive intervention; behavior change; bilingualism; biopsychosocial; cancer health disparity; cardiometabolism; comorbidity; compare effectiveness; contextual factors; demographics; diabetes prevention program; dietary; effective intervention; evidence base; exercise intervention; experience; healthy weight; high risk; high risk population; hormone therapy; improved; inclusion criteria; learning strategy; malignant breast neoplasm; meetings; novel; nutrition; obesity risk; patient oriented; population based; programs; psychosocial; recruit; remote delivery; success; telephone based; trial design; web site; weight loss intervention; weight loss program

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.

项目概要/摘要 乳腺癌 (BC) 是美国拉丁裔癌症死亡的主要原因，拉丁裔的肥胖风险很高。 和肥胖相关疾病，这些疾病与较差的癌症结果有关。 我们采取有效的干预措施，满足拉丁裔 BC 幸存者实现健康体重的多样化需求。 开发并测试了多成分减肥、饮食改变和体力活动 (PA) 对BC幸存者进行干预，重点是拉丁裔的体验式学习（EL）。 我们提出了一项序贯多重分配随机试验 (SMART)，测试 12 个月的适应性文化- 对来自不同地区的不列颠哥伦比亚省拉丁裔幸存者进行量身定制的减肥干预措施。 干预措施将使用疾病预防控制中心的糖尿病预防计划（DPP），这是一个基于证据的减肥计划， 根据我们之前的工作，我们将把 DPP 调整为远程教育。 提供的内容包括针对 BC 幸存者的信息，并针对拉丁裔女性进行文化定制。 通过 3 个西海岸 SEER 登记处招募。纳入标准：5 年内诊断为 I-III 期 BC，无。 疾病复发的证据，治疗后 >60 天，体重指数 (BMI) ≥ 30 kg/m2，基线，1, 3, 6 个月和 12 个月的评估将包括病史、饮食和患者报告的调查问卷 社会心理/生活质量结果；客观测量的体重； 血斑来测量炎症/心脏代谢生物标志物对一部分人的定性访谈。 参与者将在 1 个月和 12 个月进行。 12 个月的目标。 Vida!（生命！）计划是为了实现 基线评估后体重减轻 7%，参与者 (n=410) 将被随机分配到 ¡维达！或者¡维达！ EL。1 个月时，有反应者（体重减轻 2%）将继续他们的干预，无反应者（<2%）将继续他们的干预。 减肥）将被重新随机分配以接受增强的行为支持（即 EL、 目标 1) 比较四种自适应方法的有效性 对不列颠哥伦比亚省拉丁裔幸存者进行减肥干预措施，从 ¡维达！或者¡ Vida! + EL（第一阶段）随后 为无反应者提供为期 11 个月的增强行为支持（目标 2） 使用新颖的数据驱动方法。 确定关键个人基线特征是否调节适应性影响的方法 减肥干预措施，从而为更加个性化的适应性减肥奠定基础 探索性目标将 i) 评估干预参与是否会调节效果。 适应性干预对减肥的影响；ii) 比较适应性干预对体重变化的影响； 炎症和心脏代谢生物标志物、饮食质量和 PA；定量评估生物心理社会； 行为变化的预测因子/中介因子；以及 iv) 定性评估参与者的体验以了解 该试验将产生有关最佳策略的证据。 一项有效、可扩展的减肥计划，旨在促进不列颠哥伦比亚省拉丁裔幸存者的健康癌症生存。