Department of Nutrition, Gillings School of Global Public Health and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
School of Nursing, University of South Carolina, Columbia, SC, USA.
Contemp Clin Trials. 2021 Apr;103:106293. doi: 10.1016/j.cct.2021.106293. Epub 2021 Jan 27.
Despite the health benefits of physical activity for cancer survivors, nearly 60% of young adult cancer survivors (YACS) are physically inactive. Few physical activity interventions have been designed specifically for YACS.
To describe the rationale and design of the IMPACT (IMproving Physical Activity after Cancer Treatment) trial, which tests the efficacy of a theory-based, mobile physical activity intervention for YACS.
A total of 280 physically inactive YACS (diagnosed at ages 18-39) will be randomized to a self-help control or intervention condition. All participants will receive an activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group. Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques. The program includes: behavioral lessons; adaptive goal-setting in response to individuals' changing activity patterns; tailored feedback based on objective data and self-report measures; tailored text messages; and Facebook prompts encouraging peer support. Assessments occur at baseline, 3, 6, and 12 months. The primary outcome is total physical activity min/week at 6 months (assessed via accelerometry); secondary outcomes include total physical activity at 12 months, sedentary behavior, weight, and psychosocial measures.
IMPACT uniquely focuses on physical activity in YACS using an automated tailored mHealth program. Study findings could result in a high-reach, physical activity intervention for YACS that has potential to be adopted on a larger scale and reduce cancer-related morbidity. ClinicalTrials.gov Identifier: NCT03569605.
尽管身体活动对癌症幸存者有益健康，但近 60%的年轻成年癌症幸存者（YACS）身体活动不足。很少有专门针对 YACS 的身体活动干预措施。
描述基于理论的移动身体活动干预措施（IMPACT）试验的原理和设计，该试验测试了针对 YACS 的基于理论的移动身体活动干预措施的功效。
共有 280 名身体活动不足的 YACS（18-39 岁确诊）将被随机分为自助对照组或干预组。所有参与者都将获得一个活动追踪器和配套的移动应用程序、带蜂窝功能的秤、个人视频聊天会话以及访问 Facebook 群组的权限。干预组参与者还将获得基于社会认知理论的 6 个月的移动干预，该干预针对行为能力、自我调节、自我效能和社会支持的改善，同时结合自我调节策略和行为改变技术。该方案包括：行为课程；根据个人活动模式的变化进行适应性目标设定；根据客观数据和自我报告测量结果提供定制化反馈；定制化短信；以及鼓励同伴支持的 Facebook 提示。评估在基线、3、6 和 12 个月进行。主要结果是 6 个月时的总身体活动分钟/周（通过加速度计评估）；次要结果包括 12 个月时的总身体活动、久坐行为、体重和心理社会指标。
IMPACT 独特地通过自动化定制的移动健康计划关注 YACS 的身体活动。研究结果可能会为 YACS 提供一种高覆盖率的身体活动干预措施，该措施具有在更大范围内采用并降低癌症相关发病率的潜力。临床试验.gov 标识符：NCT03569605。
