A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

对青少年和青年儿童癌症幸存者进行移动健康和社交媒体体育活动干预的随机试验

• 批准号: 10020359
• 负责人: NINA S KADAN-LOTTICK
• 金额: $ 68.61万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10020359
• 关键词: Accelerometer; Adherence; Adolescent and Young Adult; Aftercare; Age; Behavior Therapy; Biological Assay; Biological Markers; Blood; Cancer Burden; Cardiomyopathies; Cardiopulmonary; Caring; Cellular Phone; Chronic; Communities; Competence; Control Groups; Data; Devices; Disease; Dyslipidemias; Enrollment; Evaluation; Exercise; Fasting; Fatigue; Future; Goals; Guidelines; Health; Health Insurance; Health behavior; Health education; Heart Rate; Home environment; Hospitals; Inflammatory; Insulin Resistance; Insurance; Intervention; Interview; Knowledge; Lipids; Maintenance; Mediating; Mediation; Morbidity - disease rate; Obesity; Participant; Patient Self-Report; Patients; Pediatric Oncology Group; Phase; Physical Function; Physical activity; Physiological; Pilot Projects; Population; Privatization; Procedures; Quality of life; Randomized; Randomized Controlled Trials; Research; Rest; Risk; Rural; Sampling; Site; Social Functioning; Support Groups; Survivors; Text; Treatment Efficacy; adipokines; base; behavioral health intervention; cancer therapy; cardiometabolic risk; cardiometabolism; cardiovascular health; childhood cancer survivor; cost; design; disparity reduction; efficacy testing; exercise intervention; fitbit; fitness; glucose metabolism; health disparity; health related quality of life; heart rate monitor; improved; indexing; instrument; intervention participants; mHealth; medical specialties; patient subsets; peer; peer support; personalized approach; portability; predictive marker; preference; primary outcome; psychologic; randomized trial; recruit; secondary outcome; sedentary; social; social media; survivorship; tool; uptake; virtual

PROJECT SUMMARY Interventions to increase physical activity (PA) are vitally needed in adolescent and young adult childhood cancer survivors (AYA survivors) who are largely inactive but are at lifelong elevated risk of cardiomyopathy, insulin resistance, and other cardiometabolic disorders. To reach AYA survivors, their desire for peer connections, almost ubiquitous use of smartphones and social media, and strong preferences to exercise in their homes and communities and as part of social activity must be leveraged. The intervention must also be accessible and affordable for patients without private health insurance as they are less likely to receive survivorship care and more likely to have greater morbidity. The transdisciplinary study team has completed two recent pilot studies among AYA survivors that provide substantial scientific premise for the proposed research by demonstrating that the intervention is feasible, has high rates of uptake and adherence, and appears promising for increasing PA. The proposed multi-site, randomized controlled trial (RCT) will enroll 384 AYA survivors currently ages 15.0- 20.9 years who are 3-36 months off therapy and not meeting PA guidelines. The 12-month trial will test the efficacy of a 6-month intensive multi-level PA intervention combining a wearable Fitbit PA tracker (intrapersonal level) with integration of activity data leading to individualized goal setting by text (intrapersonal level) and a private Instagram account serving as a virtual peer support group of survivors (interpersonal and community level) followed by a 6-month maintenance phase to improve PA in AYA survivors. Given the ubiquity of PA tracking devices and apps, the control group will receive the Fitbit only without integration of Fitbit data in other activities. A nationwide sample of patients drawn from rural, urban, community, and academic centers will be recruited using the Children’s Oncology Group consortium of >200 hospitals. This rigorously designed, multi-site RCT will test the efficacy of the mobile health (mHealth) behavioral intervention, compared to the control group, to achieve the following Specific Aims among AYA survivors over 12 months: Aim 1 - To increase PA; Aim 2 - To improve biomarkers predictive of cardiometabolic health; and Aim 3 - To improve health-related quality of life. Analyses of hypothesized mediation factors for Aims 1-3 and post-trial qualitative interviews among participants with and without private health insurance will provide explanatory knowledge to help refine intervention procedures and tailor the intervention for future RCTs among patient subgroups who will most benefit. If shown to be efficacious, this mHealth intervention to improve PA in AYA survivors is highly scalable because smartphones and social media are widespread, PA trackers are popular and affordable, goal setting can be automated, and social media activities do not require specialized staff.

项目摘要 在青少年和年轻的儿童癌症中，需要提高体育锻炼的干预措施（PA） 幸存者（AYA幸存者）在很大程度上不活跃，但心肌病的风险升高 阻力和其他心脏代谢疾病。为了到达Aya冲浪者，他们对同伴联系的渴望， 几乎无处不在的智能手机和社交媒体，以及在他们的家中运动的强烈偏好， 社区和作为社会活动的一部分必须掌握。干预措施也必须可以访问，并且 对于没有私人健康保险的患者负担得起，因为他们不太可能获得生存护理和 更有可能具有更大的发病率。跨学科研究团队已经完成了两项最近的试点研究 在Aya表面上，通过证明为拟议的研究提供了实质性科学前提 干预是可行的，具有很高的吸收和依从性，并且似乎有望增加 PA。拟议的多站点，随机对照试验（RCT）将招募384 AYA ERAFIVORS目前15.0-- 20。9年的休假时间为3-36个月并且不符合PA指南。这项为期12个月的试验将测试 6个月强化多层PA干预的功效结合了可穿戴的Fitbit PA跟踪器（人际室内 级别）随着活动数据的集成，导致通过文本设定个性化目标（人际级别）和 私人Instagram帐户，作为一个虚拟同伴支持小组的生存小组（人际关系和社区 水平）随后是一个为期6个月的维护阶段，以改善AYA存活中的PA。鉴于PA的无处不在 跟踪设备和应用程序，对照组只能在其他情况下仅收到FITBIT 活动。从农村，城市，社区和学术中心吸取的全国性患者样本将是 使用儿童肿瘤学集团的招募，由200家医院组成。这种严格设计的多站点 与对照组相比，RCT将测试移动健康（MHealth）行为干预的效率， 为了在12个月内实现AYA表面上的以下特定目标：目标1-增加PA；目标2- 改善生物标志物预测心脏代谢健康；目标3-以改善与健康相关的生活质量。 参与者的目标1-3和试验后定性访谈的假设调解因素的分析 有或没有私人健康保险，将提供剥夺知识以帮助完善干预 程序并定制对最大受益的患者子组中未来RCT的干预措施。如果显示 为了提高效率，这种MHealth干预措施以改善AYA生存的PA是高度可扩展的，因为 智能手机和社交媒体广泛，PA跟踪器很受欢迎且负担得起，目标设定可能是 自动化和社交媒体活动不需要专业的员工。