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

项目总结 对于青春期和青壮年的儿童癌症来说，增加体力活动(PA)的干预是至关重要的 幸存者(Aya幸存者)基本上不活动，但终生患心肌病的风险增加，胰岛素 抵抗力和其他心脏代谢障碍。为了联系到阿雅的幸存者，他们对同伴联系的渴望， 几乎无处不在地使用智能手机和社交媒体，以及强烈喜欢在家里和 必须利用社区，并将其作为社会活动的一部分。干预还必须是可访问的，并且 对于没有私人医疗保险的患者来说负担得起，因为他们不太可能接受生存护理和 更有可能有更高的发病率。跨学科研究小组最近完成了两项初步研究 在为拟议研究提供实质性科学前提的Aya幸存者中，通过展示 干预措施是可行的，具有较高的接受率和依从率，并似乎有希望增加 爸。拟议的多点随机对照试验(RCT)将招募384名目前年龄为15.0岁的Aya幸存者。 20.9岁，停止治疗3-36个月，不符合PA指南。为期12个月的审判将考验 结合可穿戴Fitbit PA跟踪器(个人内部)进行为期6个月的强化多水平PA干预的疗效 级别)与活动数据的集成，从而通过文本(个人级别)和 作为幸存者(人际和社区)的虚拟同伴支持小组的私人Instagram帐户 水平)，然后进行为期6个月的维持阶段，以改善Aya幸存者的PA。鉴于PA无处不在 跟踪设备和应用程序，控制组将仅接收Fitbit，而不会将Fitbit数据集成到其他 活动。从农村、城市、社区和学术中心抽取的全国患者样本将是 从200家医院组成的儿童肿瘤学集团联盟招募。这个设计严谨的多站点 RCT将测试移动健康(MHealth)行为干预的效果，与对照组相比， 在12个月内在Aya幸存者中实现以下具体目标：目标1--增加PA；目标2-- 改善预测心脏代谢健康的生物标志物；以及目标3-提高与健康相关的生活质量。 AIMS 1-3的假设调解因素分析及试后定性访谈 无论有没有私人医疗保险，都将提供解释性知识，以帮助完善干预措施 在受益最大的患者群体中，为未来的随机对照试验制定程序和量身定制干预措施。如果显示 为了有效，这种改善Aya幸存者PA的mHealth干预措施具有高度的可扩展性，因为 智能手机和社交媒体普及，PA追踪器流行且价格实惠，设定目标可以 自动化和社交媒体活动不需要专门的工作人员。

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.