Multi-site adaptive trial of a technology-based, EHR-integrated physical activity intervention in breast and endometrial cancer survivors

项目摘要/摘要 中等到剧烈的体力活动(MVPA)的增加与治疗的减少有关- 乳腺癌和子宫内膜癌的相关副作用、癌症复发和死亡率以及生活质量的提高 幸存者。然而，大多数幸存者(~70%)不符合针对癌症的MVPA建议 (即每周150分钟)。MVPA支持不是标准护理的一部分，因此很少有幸存者能够获得 有效的MVPA计划。未能将MVPA计划转化为医疗保健是大多数干预措施的结果 是密集的现场计划，同时向所有参与者提供多个组件。这个“一个-- “放之四海而皆准”的方法既没有考虑到个人的需要，也不能实际地在 生还者护理。移动健康工具(即智能手机应用程序、Fitbit、文本消息)价格低廉， 已经证明在其他人群中增加MVPA是有效的。因此，它们可能是可伸缩性更强、更少 资源密集型战略，以增加更多幸存者的MVPA。集成可穿戴MVPA的能力 将监测数据写入电子健康记录(EHR)进一步增强了技术支持的潜力 将MVPA干预整合到癌症治疗中。然而，对这些工具的反应各不相同 并可能作为逐步进展的MVPA计划的一部分而有所不同(根据每周目标分钟)和他们的 对发病率指标的影响尚不清楚。虽然包括Fitbit在内的最小干预集成到 EHR(Fitbit+EHR)可能足以让一些癌症幸存者增加他们的MVPA，其他人需要更多 支持。此外，一些幸存者可能会在早期需要这种额外的支持，而另一些人可能会提前成功， 但后来当MVPA目标增加时，这一计划就失败了。缺乏证据来确定：a)最好的 在非应答者中增加MVPA的增强策略是提供另一个mHealth组件(即在线 练习视频)单独或使用更传统的组件(例如，电话辅导)，以及b)最好的 适应性干预是为了改善发病率指标。因此，我们建议利用一种新颖的自适应 干预设计，以确定最佳：1)增强成分(S)，以解决无反应和 2)适应性干预，以改善发病率指标(即症状负担和功能表现)。 非活动性乳腺癌和子宫内膜癌幸存者(n=320)将获得整合到EHR中的Fitbit (Fitbit+EHR)。那些没有对Fitbit+EHR干预措施做出反应的人，这证明他们没有充分 增加他们的MVPA将被重新随机到随后的两种增强策略之一：(1)在线 健身房或(2)在线健身房和教练电话。应答者将继续使用Fitbit+EHR 6个月。这个 该项目意义重大，因为它的目标是开发一种有效的、可扩展的MVPA癌症干预 幸存者将从一刀切的方式转变为动态的、量身定做的MVPA推广方式 通过在正确的时间确定无响应者并为他们提供额外的干预组件 增加MVPA并改善健康和疾病结果是必要的。

PROJECT SUMMARY/ABSTRACT Increased moderate-to-vigorous intensity physical activity (MVPA) is associated with reductions in treatment- related side effects, cancer recurrence and mortality, and increased QOL in breast and endometrial cancer survivors. However, the majority (~70%) of survivors do not meet cancer-specific MVPA recommendations (i.e., 150 mins/week). MVPA support is not part of standard care, resulting in few survivors having access to efficacious MVPA programs. Failure to translate MVPA programs into care is a result of most interventions being intense, on-site programs that deliver multiple components simultaneously to all participants. This “one- size-fits-all” approach does not account for individual needs, nor can it realistically be implemented into survivorship care. mHealth tools (i.e. smartphone applications, Fitbits, text messages), are inexpensive and have demonstrated efficacy for increasing MVPA in other populations. Thus, they may be a more scalable, less resource-intensive strategy to increase MVPA in more survivors. The ability to integrate wearable MVPA monitor data into the electronic health record (EHR) further enhances the potential for a technology-supported MVPA intervention to be integrated into cancer care. However, responses to these tools are heterogeneous and may vary as part of a gradually progressing (in terms of weekly goal mins) MVPA program and their effects on morbidity indicators is unknown. While a minimal intervention including the Fitbit integrated into the EHR (Fitbit+EHR) may be sufficient for some cancer survivors to increase their MVPA, others will need more support. Further, some survivors may need this additional support early on, while others may succeed early, but fail later when the MVPA goal increases. Evidence is lacking to determine: a) whether the best augmentation tactic for increasing MVPA in non-responders is to offer another mHealth component (i.e. online exercise videos) alone or with a more traditional component (i.e., telephone coaching) and b) what the best adaptive intervention is to improve morbidity indicators. Thus, we propose to utilize a novel adaptive intervention design to determine the optimal: 1) augmentation component(s) to address non-response and 2) adaptive intervention for improving morbidity indicators (i.e., symptom burden and functional performance). Inactive breast and endometrial cancer survivors (n=320) will receive a Fitbit integrated into the EHR (Fitbit+EHR). Those who do not respond to the Fitbit+EHR intervention as evidenced by failure to sufficiently increase their MVPA will be re-randomized to one of two subsequent augmentation tactics, either: (1) online gym or (2) online gym and coaching calls. Responders will continue with the Fitbit+EHR for 6 months. The project is significant because it aims to develop an effective and scalable MVPA intervention for cancer survivors that will move from a one-size-fits-all approach to a dynamic, tailored approach for MVPA promotion by identifying non-responders at the right time and providing them with the additional intervention components necessary to increase MVPA and improve health and disease outcomes.