Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, United States of America; Georgetown University School of Medicine, Washington, DC, United States of America.
Fred Hutchinson Cancer Center, Seattle, WA, United States of America; Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States of America; University of Washington, Seattle, WA, United States of America.
Contemp Clin Trials. 2024 Oct;145:107645. doi: 10.1016/j.cct.2024.107645. Epub 2024 Jul 28.
Interventions to increase physical activity are needed in adolescent and young adult survivors of childhood cancer who are largely inactive but at lifelong elevated risk of multiple chronic conditions improved by physical activity. The goals of the StepByStep study are to evaluate the effects of a 48-week distance-based, multi-component mobile health and social media behavioral intervention on physical activity, biomarkers of cardiometabolic health, and health-related quality of life.
This ongoing study is a two-arm, prospective, multi-site randomized controlled trial. 384 childhood cancer survivors age ≥ 15 years and < 21 years who were 3-36 months off therapy and not meeting physical activity guidelines were enrolled. The trial will test the efficacy of a 24-week intensive multi-component physical activity intervention combining a wearable physical activity tracker, social media peer support group, and individualized goal setting followed by a 24-week maintenance phase of the intervention to improve outcomes. The control group receives the wearable physical activity tracker only.
There is a growing need for novel, developmentally appropriate interventions to increase physical activity and improve the health trajectory of adolescent and young adult survivors of childhood cancer. If efficacious, this portable and scalable intervention would be a much-needed tool to reduce the morbidity from cancer treatment and improve quality of life among survivors after treatment ends.
ClinicalTrials.gov Identifier: NCT04089358; COG Identifier: ALTE2031.
儿童癌症幸存者在青少年和年轻成年期往往缺乏运动，但他们终身患有多种慢性疾病的风险增加，而运动可以改善这些疾病。StepByStep 研究的目的是评估一个为期 48 周的基于距离的、多组分移动健康和社交媒体行为干预对身体活动、心血管代谢健康生物标志物和健康相关生活质量的影响。
这是一项正在进行的、两臂、前瞻性、多地点随机对照试验。招募了 384 名年龄≥15 岁且<21 岁、治疗后 3-36 个月、不符合身体活动指南的儿童癌症幸存者。该试验将测试一种 24 周强化多组分身体活动干预的疗效，该干预结合可穿戴身体活动追踪器、社交媒体同伴支持小组和个性化目标设定，然后是 24 周的干预维持阶段，以改善结果。对照组仅接受可穿戴身体活动追踪器。
儿童癌症幸存者的青少年和年轻成年人需要新的、适合发展的干预措施来增加身体活动，改善健康轨迹。如果有效，这种便携且可扩展的干预措施将是一种急需的工具，可以减少癌症治疗的发病率，并在治疗结束后提高幸存者的生活质量。
ClinicalTrials.gov 标识符：NCT04089358；COG 标识符：ALTE2031。
