A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol.

A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol.
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对乳腺癌和子宫内膜癌幸存者进行电子健康综合体力活动促进干预的多中心试验:MyActivity 研究方案。

DOI:
10.1016/j.cct.2023.107187
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发表时间:
2023
影响因子:
2.2
通讯作者:
Barber,Emma
Barber,Emma
中科院分区:
医学4区
文献类型:
--
作者:
Cadmus-Bertram,Lisa;Solk,Payton;Agnew,Megan;Starikovsky,Julia;Schmidt,Christian;Morelli,WhitneyA;Hodgson,Vanessa;Freeman,Hannah;Muller,Laura;Mishory,Abby;Naxi,Sondra;Carden,Lillian;Tevaarwerk,AmyeJ;Wolter,Melanie;Barber,Emma

文献摘要

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尽管中等到剧烈的体力活动(MVPA)对乳腺癌和子宫内膜癌幸存者有已知的好处,但大多数人活动不足,干预措施反应不一,MVPA规划整合到癌症护理中的情况有限。循序渐进的护理方法是加强体力活动规划的一项战略,这种方法首先提供资源密集度最低的干预措施,然后根据个人反应增加其他组成部分。然而,最有效的干预强化策略尚不清楚。在这项针对治疗后、不活跃的乳腺癌和子宫内膜癌幸存者(n=9323)的单一随机试验中,参与者接受最低限度的干预,包括与他们诊所的患者门户链接的Fitbit,进而接受每周通过该门户提供反馈的电子健康记录(EHR)。MVPA的进展摘要通过电子病历发送给参与者的肿瘤学团队。在4周、8周、12周、16周和20周对MVPA的遵从性进行评估;在每个时间点,无响应者(那些在前4周达到MVPA目标的≤80%的人)在24周的剩余干预中随机进行一次,以获得两种“升压”条件之一:(1)在线健身房或(2)教练电话,而响应者继续进行最低限度的FITBIT+EHR干预。主要结果是24周和48周时活动仪测量的MVPA。次要结果包括24周和48周的症状负担和功能表现。这项试验将通过确定无反应者并为他们提供必要的干预增强来增加MVPA和改善健康结果,从而为幸存者提供有效、可扩展和量身定制的干预措施。临床试验注册编号NCT04262180
Despite the known benefits of moderate-to-vigorous physical activity (MVPA) for breast and endometrial cancer survivors, most are insufficiently active, interventions response is heterogeneous, and MVPA programming integration into cancer care is limited. A stepped care approach, in which the least resource-intensive intervention is delivered first and additional components are added based on individual response, is one strategy to enhance uptake of physical activity programming. However, the most effective intervention augmentation strategies are unknown. In this singly randomized trial of post-treatment, inactive breast and endometrial cancer survivors (n= 323), participants receive a minimal intervention including a Fitbit linked with their clinic's patient portal and, in turn, the electronic health record (EHR) with weekly feedback delivered via the portal. MVPA progress summaries are sent to participants' oncology team via the EHR. MVPA adherence is evaluated at 4, 8, 12, 16 and 20 weeks; non-responders (those meeting ≤80% of the MVPA goal over previous 4 weeks) at each timepoint are randomized once for the remainder of the 24-week intervention to one of two “step-up” conditions: (1) online gym or (2) coaching calls, while responders continue with the minimal Fitbit+EHR intervention. The primary outcome is ActiGraph-measured MVPA at 24 and 48 weeks. Secondary outcomes include symptom burden and functional performance at 24 and 48 weeks. This trial will inform development of an effective, scalable, and tailored intervention for survivors by identifying non-responders and providing them with the intervention augmentations necessary to increase MVPA and improve health outcomes.Clinical Trials Registration # NCT04262180