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 拉丁裔儿童癌症存活率增加了心脏代谢功能障碍的风险。而体育锻炼 （PA）与癌症复发，心脏代谢功能障碍和较高生活质量的较低风险有关， 57％的拉丁文幸存者是不活跃的。文化量身定制的干预措施以增加Latinx AYA幸存者的PA DO 目前不存在迫切需要。我们将通过有效利用 我们正在进行的阶级随机分配的儿童肿瘤学小组（COG）中的基础设施 对照试验（RCT; U01CA246665）调查了对AYHOLE儿童癌症的MHealth PA干预 讲英语的幸存者。尽管有19009年的大流行，但我们还是成功地注册了 来自COG的患者，进行评估和干预组件进行远程进行。因为U01 StepbyStep RCT仅限于英语，我们建议（1）应用文化中心流程 使用一般的StepbyStep干预作为起点，行为干预措施创建新颖 干预措施和（2）在短期效率RCT中测试所得量身定制的干预措施。我们将 有效地扩展了我们在COG内建立的研究基础设施，以招募说西班牙语的拉丁冲浪者 和/或英语。为了响应PAR-21-190（模块化R01），我们提出了以下特定目的： 1。使用迭代方法来开发一种新颖的文化量身定制的基于遥控的体育活动 在20个拉丁裔Aya儿童期癌症生存中的干预，他们的首选语言是西班牙语或 英语。迭代过程将结合三轮的干预组件测试 进行定性访谈，以获得参与的反馈，以指导干预修改。 2。进行RCT，以测试新型的文化量身定制的基于遥控的体育活动干预措施 在一组160个Latinx Aya儿童癌症中证明效率超过12周 首选语言是西班牙语或英语的幸存者（每个随机化臂n = 80） 符合PA指南。对照组只会收到一个fitbit。我们将测试以下假设（H）： H1：干预参与者将在现代到凶猛的PA（主要结果）上增加更多 比通过加速度测定法评估的对照。 H2。干预参与者将在心肺健康和休息心脏方面有更大的改善 速率比对照2分钟测试和心率监测器评估（探索结果）所评估的速率。 H3：干预参与者将在全球，身体和社会功能方面取得更大的改善，并且 通过经过验证的自我报告工具（探索性结果）评估的对照患者的疲劳。 3。进行两轮试验后定性访谈，n = 30，对于密集干预阶段，n = 30 对于维护干预阶段，以确定改善两者的可接受性和指导 干预阶段，以准备完全动力的长期RCT。