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

对乳腺癌和子宫内膜癌幸存者进行基于技术、电子病历整合的体力活动干预的多地点适应性试验

• 批准号: 10524163
• 负责人: Lisa Anne CadmusBertram
• 金额: $ 1.55万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10524163
• 关键词: Accelerometer; Accountability; Address; American Cancer Society; Breast; Cancer Prognosis; Cancer Survivor; Cancer Survivorship; Caring; Characteristics; Chronic Disease; Clinic; Clinic Visits; Data; Development; Disease; Disease Outcome; Dose; Electronic Health Record; Electronic Mail; Endometrial Carcinoma; Ensure; Exercise; Failure; Fatigue; Feedback; Goals; Health; Human; Individual; Intervention; Knowledge; Malignant Neoplasms; Measures; Morbidity - disease rate; Participant; Patients; Performance; Persons; Physical activity; Physical activity scale; Population; Quality of life; Randomized; Recommendation; Resources; Self Efficacy; Site; Supervision; Survivors; Symptoms; Technology; Testing; Text Messaging; Time; Translating; Transportation; Treatment Side Effects; Visit; Woman; adaptive intervention; base; behavior change; burden of illness; cancer care; cancer recurrence; cost; design; disorder risk; exercise intervention; fitbit; follow-up; functional status; improved; innovation; intervention effect; mHealth; malignant breast neoplasm; mortality; novel; patient health information; patient portal; personalized approach; physical inactivity; primary outcome; programs; responders and non-responders; response; smartphone Application; standard care; success; survivorship; symptomatic improvement; telephone coaching; therapy design; tool; translational barrier; vigorous intensity

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.

项目总结/摘要 增加中度至剧烈强度的体力活动（MVPA）与治疗减少相关- 乳腺癌和子宫内膜癌患者的相关副作用、癌症复发和死亡率以及生活质量增加 幸存者然而，大多数（约70%）的幸存者不符合癌症特异性MVPA的建议 (i.e., 150分钟/周）。MVPA支持不是标准护理的一部分，导致很少有幸存者能够获得 有效的MVPA计划。大多数干预措施都未能将MVPA计划转化为护理 是紧张的，现场程序，同时提供多个组件给所有参与者。这个“一个- “一刀切”的做法没有考虑到个人的需要，也不可能实际地落实到 生存护理。移动健康工具（即智能手机应用程序，Fitbit，短信）价格低廉， 在其他人群中证明了增加MVPA的有效性。因此，它们可能是更可扩展、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 监测数据到电子健康记录（EHR）进一步提高了技术支持的潜力， MVPA干预将被纳入癌症护理。然而，对这些工具的反应各不相同 并且可以作为逐渐进展的（就每周目标分钟数而言）MVPA计划的一部分而变化， 对发病率指标的影响尚不清楚。虽然最小的干预，包括Fitbit集成到 EHR（Fitbit+EHR）可能足以让一些癌症幸存者增加他们的MVPA，其他人则需要更多 支持.此外，一些幸存者可能需要这种额外的支持早期，而其他人可能成功早期， 但是当MVPA目标增加时，稍后失败。没有证据可以确定：a）最好的 增加无应答者MVPA的增强策略是提供另一个移动健康组件（即在线 锻炼视频）单独或与更传统的组件（即，电话辅导）和B）什么是最好的 适应性干预是改善发病率指标。因此，我们建议利用一种新的自适应 干预设计，以确定最佳：1）解决无应答问题的强化组成部分， 2)改善发病率指标的适应性干预（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）将获得集成到EHR中的Fitbit （Fitbit+EHR）。那些对Fitbit+EHR干预没有反应的人，如未能充分 增加他们MVPA将被重新随机分配到两个随后的增强策略之一，或者：（1）在线 健身房或（2）在线健身房和教练电话。响应者将继续使用Fitbit+EHR 6个月。的 该项目意义重大，因为它旨在开发一种有效且可扩展的MVPA癌症干预措施 幸存者将从一刀切的方法转向动态的，量身定制的MVPA推广方法 通过在正确的时间识别无反应者，并为他们提供额外的干预成分， 增加MVPA和改善健康和疾病结果是必要的。