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

摘要 拉丁裔儿童癌症幸存者患心脏代谢功能障碍的风险增加。在体力活动时 (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有关， 57%的拉丁裔幸存者不活跃。为拉丁裔Aya幸存者增加PA的文化定制干预措施 尽管他们迫切需要，但目前并不存在。我们将通过有效地利用 我们正在进行的StepByStep随机化创建的儿童肿瘤学小组(COG)的基础设施 研究mHealth PA干预Aya儿童癌症的对照试验(RCT；U01CA246665) 说英语的人中的幸存者。尽管新冠肺炎大流行，我们还是成功地注册了 来自COG的患者，远程进行评估和干预组件。因为U01 StepByp RCT仅限于讲英语的人，我们建议(1)将文化中心过程应用于 行为干预，以一般的StepByStep干预为起点，创建了一个新颖的 干预和(2)测试由此产生的文化定制的干预在短期内的有效性随机对照试验。我们会 有效地扩展我们在COG内部建立的研究基础设施，以招募会说西班牙语的Latinx幸存者 和/或英语。针对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、基于远程的多层次体力活动 对20名首选西班牙语或拉丁语的拉美裔Aya儿童癌症幸存者的干预 英语。迭代过程将结合交替进行干预组件的3轮测试 通过定性访谈获得参与者反馈，以指导干预措施的修改。 2.进行随机对照试验，测试新的文化定制远程体力活动干预措施，以 在一组单独的160例Latinx Aya儿童癌症患者中显示出超过12周的疗效 首选语言为西班牙语或英语的幸存者(每个随机分组组80人)和不使用西班牙语或英语的幸存者 符合PA指南。对照组将只收到一个Fitbit。我们将检验以下假设(H)： H1：干预参与者的中度到剧烈的PA将有更大的增加(主要结果) 而不是通过加速度计评估的对照组。 H2。干预参与者将在心肺健康和静息心脏方面有更大的改善 通过2分钟台阶试验和心率监测器评估的心率(探索性结果)。 H3：干预参与者将在全球、身体和社会功能方面有更大改善，并 通过有效的自我报告工具(探索性结果)评估的疲劳感高于对照组患者。 3.进行两轮试验后定性访谈，强化干预阶段n=30，n=30 在维护干预阶段，确定两者的可接受性和改进指导 干预阶段，为全面、长期的随机对照试验做准备。

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.