Developing and Testing a Culturally Tailored Mobile Health and Social MediaPhysical Activity Intervention Among Adolescent and Young Adult ChildhoodCancer Survivors

开发和测试针对青少年和青年儿童癌症幸存者的文化定制移动健康和社交媒体体育活动干预

• 批准号: 10736526
• 负责人: NINA S KADAN-LOTTICK
• 金额: $ 43.12万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10736526
• 关键词: Accelerometer; Adolescent and Young Adult; Age; Behavior Therapy; COVID-19 pandemic; Cancer Control; Cardiomyopathies; Cardiopulmonary; Chronic; Communication; Communities; Control Groups; Diet and Nutrition; Dyslipidemias; Enrollment; Evaluation; Fatigue; Feedback; Functional disorder; Funding; Future; General Population; Goals; Guidelines; Health; Health behavior; Heart Rate; Infrastructure; Instagram; Insulin Resistance; Intervention; Intervention Studies; Interview; Language; Late Effects; Latinx; Maintenance; Malignant Neoplasms; Modeling; Modification; Obesity; Outcome; Participant; Patient Recruitments; Patient Self-Report; Patients; Pediatric Oncology Group; Phase; Physical Function; Physical activity; Population Sciences; Preparation; Privatization; Process; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Recurrent Malignant Neoplasm; Reporting; Research; Rest; Risk; Site; Social Functioning; Step Tests; Support Groups; Survivors; Target Populations; Test Result; Testing; Time; Treatment Efficacy; arm; cancer complication; cancer recurrence; cancer risk; cancer therapy; cardiometabolic risk; cardiometabolism; cardiovascular health; childhood cancer survivor; curative treatments; efficacy testing; exercise intervention; fitbit; fitness; health related quality of life; heart rate monitor; improved; innovation; instrument; intervention participants; mHealth; moderate-to-vigorous physical activity; novel; outcome disparities; participant enrollment; peer support; portability; predictive marker; preference; prevent; primary outcome; recruit; response; sedentary; social; social media; systematic review; therapy development; virtual

ABSTRACT Latinx childhood cancer survivors have an increased risk of cardiometabolic dysfunction. While physical activity (PA) is associated with lower risk of cancer recurrence, cardiometabolic dysfunction, and higher quality of life, 57% of Latinx survivors are inactive. Culturally tailored interventions to increase PA for Latinx AYA survivors do not currently exist despite their urgent need. We will address this critical gap by efficiently leveraging the infrastructure in the Children’s Oncology Group (COG) created by our ongoing StepByStep randomized controlled trial (RCT; U01CA246665) that investigates a mHealth PA intervention in AYA childhood cancer survivors among English-speakers. Despite the COVID-19 pandemic, we have been successful in enrolling patients from COG, conducting assessments and intervention components remotely. Because the U01 StepByStep RCT is limited to English speakers, we propose (1) to apply a cultural centering process for behavioral interventions, using the general StepByStep intervention as a starting point, to create a novel intervention and (2) to test the resulting culturally tailored intervention in a short term efficacy RCT. We will efficiently extend our established study infrastructure within COG to recruit Latinx survivors who speak Spanish and/or English. In response to PAR-21-190 (Modular R01), we propose the following Specific Aims: 1. Use an iterative approach to develop a novel, culturally tailored multilevel remote-based physical activity intervention among 20 Latinx AYA childhood cancer survivors whose preferred language is Spanish or English. The iterative process will combine 3 rounds of testing of the intervention components alternating with qualitative interviews to obtain participant feedback to guide intervention modifications. 2. Conduct a RCT to test the novel culturally tailored remote-based physical activity intervention to demonstrate efficacy over 12 weeks among a separate group of 160 Latinx AYA childhood cancer survivors whose preferred language is Spanish or English (n=80 per randomization arm) and who do not meet PA guidelines. The control group will receive a Fitbit only. We will test the following hypotheses (H): H1: Intervention participants will have greater increases in moderate-to-vigorous PA (primary outcome) than controls as assessed by accelerometry. H2. Intervention participants will have greater improvements in cardiopulmonary fitness and resting heart rate than controls as assessed by the 2-minute step test and heart rate monitor (exploratory outcomes). H3: Intervention participants will have greater improvements in global, physical, and social functioning and fatigue than control patients as assessed by validated self-report instruments (exploratory outcomes). 3. Conduct two rounds of post-trial qualitative interviews, n=30 for the intensive intervention phase and n=30 for the maintenance intervention phase, to determine acceptability of and guidance on improving both intervention phases in preparation for a fully powered, longer term RCT.

抽象的 拉丁裔儿童癌症幸存者在进行体力活动时出现心脏代谢功能障碍的风险增加。 (PA) 与较低的癌症复发风险、心脏代谢功能障碍和较高的生活质量相关， 57% 的拉丁裔幸存者缺乏针对文化定制的干预措施来增加拉丁裔 AYA 幸存者的 PA。 尽管他们迫切需要，但目前并不存在，我们将通过有效利用来解决这一关键差距。 儿童肿瘤学组 (COG) 的基础设施由我们正在进行的 StepByStep 随机化创建 对照试验（RCT；U01CA246665）调查 mHealth PA 干预 AYA 儿童癌症 尽管发生了新冠肺炎 (COVID-19) 大流行，但我们仍成功招募了英语使用者中的幸存者。 来自 COG 的患者，远程进行评估和干预组件 因为 U01。 StepByStep RCT 仅限于讲英语的人，我们建议 (1) 应用文化中心流程 行为干预，以一般的逐步干预为起点，创造一种新颖的 干预措施和（2）在短期疗效随机对照试验中测试由此产生的文化定制干预措施。 有效扩展我们在 COG 内建立的研究基础设施，以招募会说西班牙语的拉丁裔幸存者 和/或英语 为了响应 PAR-21-190（模块化 R01），我们提出以下具体目标： 1. 使用迭代方法开发一种新颖的、根据文化定制的多层次远程身体活动 对 20 名拉丁裔 AYA 儿童癌症幸存者进行干预，他们的首选语言是西班牙语或 迭代过程将交替组合 3 轮干预组件测试。 通过定性访谈来获取参与者的反馈来指导干预措施的修改。 2. 进行随机对照试验来测试新颖的根据文化定制的远程身体活动干预措施 在 160 名拉丁 AYA 儿童癌症单独组中证明了 12 周内的疗效 首选语言是西班牙语或英语的幸存者（每个随机组 n=80）以及不喜欢西班牙语或英语的幸存者 符合 PA 指南。对照组将仅收到 Fitbit。我们将测试以下假设 (H)： H1：干预参与者的中度至强度 PA 会有更大的增加（主要结果） 比通过加速度测量评估的对照。 H2. 干预参与者的心肺健康和静息心脏会有更大的改善。 通过 2 分钟步进测试和心率监测器评估，心率高于对照组（探索性结果）。 H3：干预参与者的整体、身体和社会功能将得到更大的改善 通过经过验证的自我报告工具评估，疲劳程度高于对照患者（探索性结果）。 3. 进行两轮审后定性访谈，强化干预阶段n=30，n=30 对于维护干预阶段，确定改进两者的可接受性和指导 干预阶段，为全面、长期的 RCT 做准备。