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.

项目总结/摘要 乳腺癌（BC）是美国拉丁裔癌症死亡的主要原因。拉丁裔肥胖风险高 和肥胖相关的疾病，这与较差的癌症结果有关。严重缺乏 一个有效的干预措施，以解决拉丁裔BC幸存者的不同需求，以实现健康的体重。我们 已经开发和测试了多组分减肥，饮食变化和身体活动（PA） 在不列颠哥伦比亚省幸存者中进行干预，重点是拉丁美洲人的体验式学习。作为下一步， 我们提出了一个连续的多分配随机试验（SMART）测试12个月的适应性文化- 在地理上不同的拉丁裔BC幸存者群体中量身定制的减肥干预措施。自适应 干预措施将使用疾病预防控制中心的糖尿病预防计划（DPP），一个以证据为基础的减肥计划， 作为核心教育内容。基于我们之前的工作，我们将调整DPP， 提供，包括特定的信息不列颠哥伦比亚省的幸存者，并在文化上适合拉丁美洲人。妇女将被 通过3个西海岸SEER登记处招募。入选标准：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 心理社会/生活质量结局;客观测量的体重;加速度计测量的PA;和干燥 血斑以测量炎症/心脏代谢生物标志物。定性访谈的子集 参与者将在1个月和12个月时参加。12个月的目标…维达！(Life!)计划是为了实现 7%的体重减轻。基线评估后，参与者（n=410）将被随机分配到维达！或者维达！+ El.在1个月时，应答者（体重减轻> 2%）将继续进行干预，而无应答者（<2%）将继续进行干预。 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，并提供杂货）。目的1）比较四种自适应 拉丁裔BC幸存者的减肥干预措施，从维达开始！或者维达！+ EL（第1阶段），然后是 对无反应者进行为期11个月的增强行为支持（第2阶段）。目标2）使用一种新的数据驱动的 确定关键的个人基线特征是否缓和自适应 干预减肥，从而为更个性化的适应性减肥奠定基础 战略布局探索性目标将i）评估干预参与是否会调节 适应性干预对体重减轻的影响; ii）比较适应性干预对体重减轻的影响。 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 影响研究结果的因素。该试验将产生关于最佳策略的证据， 有效的，可扩展的减肥计划，以促进拉丁裔BC幸存者的健康癌症生存率。