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: 9895223
• 负责人: NINA S KADAN-LOTTICK
• 金额: $ 75.27万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9895223
• 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 青少年和年轻成人儿童癌症患者迫切需要增加体力活动（PA）的干预措施 幸存者（AYA幸存者），他们基本上不活动，但终身心肌病风险升高，胰岛素 抵抗和其他心脏代谢紊乱。为了接触AYA幸存者，他们对同龄人联系的渴望， 几乎无处不在的智能手机和社交媒体的使用，以及在家中锻炼的强烈偏好， 必须利用社区和社会活动的一部分。干预措施还必须是可获得的， 没有私人医疗保险的患者负担得起，因为他们不太可能接受生存护理， 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试点研究 在AYA幸存者中，通过证明 干预措施是可行的，有很高的吸收率和坚持率，并且似乎有希望增加 宾夕法尼亚州拟议的多中心随机对照试验（RCT）将招募384名目前年龄为15.0岁的AYA幸存者， 20.9 3-36个月未接受治疗且不符合PA指南的患者。为期12个月的试验将测试 结合可穿戴Fitbit PA跟踪器（个人内）的6个月强化多水平PA干预的疗效 水平）与活动数据的整合，导致通过文本（自我层次）和 私人Instagram账户，作为幸存者的虚拟同伴支持小组（人际和社区 水平），然后是6个月的维持阶段，以改善AYA幸存者的PA。鉴于PA的普遍性， 跟踪设备和应用程序，对照组将只收到Fitbit，而不会将Fitbit数据集成到其他设备和应用程序中。 活动将从全国农村、城市、社区和学术中心抽取患者样本， 招募使用儿童肿瘤组联盟>200家医院。这个设计严谨的多站点 RCT将测试移动的健康（mHealth）行为干预的有效性，与对照组相比， 在12个月以上的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;目标3 -改善健康相关的生活质量。 目标1-3的假设中介因素分析和参与者的试验后定性访谈 有和没有私人健康保险将提供解释性知识，以帮助完善干预措施 程序和定制干预措施，为未来的随机对照试验中的患者亚组谁将受益最大。如果示出 为了有效，这种改善AYA幸存者PA的mHealth干预措施具有高度可扩展性， 智能手机和社交媒体很普遍，PA跟踪器很受欢迎，价格实惠，目标设定可以 自动化和社交媒体活动不需要专门的工作人员。