适形抗癌体能促进试验物理活动推广干预对转移性乳腺癌患者身体活动和患者报告结果的可行性和初步效果。
Feasibility and preliminary effects of the Fit2ThriveMB pilot physical activity promotion intervention on physical activity and patient reported outcomes in individuals with metastatic breast cancer.
机构信息
Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, 680 N Lake Shore Drive, Suite 1400, Chicago, IL, 60611, USA.
Department of Medicine, Hematology and Oncology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
出版信息
Breast Cancer Res Treat. 2024 Nov;208(2):391-403. doi: 10.1007/s10549-024-07432-5. Epub 2024 Jul 16.
PURPOSE
Physical activity research among patients with metastatic breast cancer (MBC) is limited. This study examined the feasibility and potential benefits of Fit2ThriveMB, a tailored mHealth intervention.
METHODS
Insufficiently active individuals with MBC (n = 49) were randomized 1:1 to Fit2ThriveMB (Fit2ThriveMB app, Fitbit, and weekly coaching calls) or Healthy Lifestyle attention control (Cancer.Net app and weekly calls) for 12 weeks. Fit2ThriveMB aimed to increase daily steps via an algorithm tailored to daily symptom rating and step goal attainment. The primary outcome was feasibility defined as ≥ 80% completion rate. Secondary feasibility metrics included meeting daily step goal and wearing the Fitbit ≥ 70% of study days, fidelity, adherence to intervention features and safety. Secondary outcomes included physical activity, sedentary time, patient reported outcomes (PROs), health-related quality of life (QOL) and social cognitive theory constructs. A subsample (n = 25) completed functional performance tests via video conferencing.
RESULTS
The completion rate was 98% (n = 1 died). No related adverse events were reported. Fit2ThriveMB participants (n = 24) wore the Fitbit 92.7%, met their step goal 53.1%, set a step goal 84.6% and used the app 94.1% of 84 study days. Intent-to-treat analyses indicated trends toward improvements in activity, QOL, and some PROs, social cognitive theory constructs, and functional performance tests favoring the Fit2ThriveMB group. Significant effects favoring Fit2ThriveMB were observed for self-efficacy and goal-setting. However, some PROs and functional performance improvements favored the control group (p-values > 0.05).
CONCLUSIONS
Fit2ThriveMB is feasible and safe for patients with MBC and warrants further evaluation in randomized controlled trials with larger sample sizes. Registration Clinicaltrials.gov NCT04129346, https://clinicaltrials.gov/ct2/show/NCT04129346.
目的
转移性乳腺癌（MBC）患者的身体活动研究有限。本研究检验了 Fit2ThriveMB 这一经过定制的移动医疗干预措施的可行性和潜在益处，Fit2ThriveMB 是一种针对 MBC 患者的定制化 mHealth 干预措施。
方法
将 49 名活动量不足的 MBC 患者随机分为 Fit2ThriveMB 组（Fit2ThriveMB 应用程序、Fitbit 和每周辅导电话）和健康生活方式对照组（Cancer.Net 应用程序和每周电话），每组各 24 名患者，干预时长为 12 周。Fit2ThriveMB 的目的是通过根据日常症状评分和目标达成情况量身定制的算法来增加每日步数。主要结局指标为≥80%的完成率，次要可行性指标包括达到日常目标步数、每天佩戴 Fitbit 设备≥70%的研究天数、忠实度、对干预措施的依从性以及安全性。次要结局指标包括身体活动、久坐时间、患者报告的结局（PRO）、健康相关生活质量（QOL）和社会认知理论构念。一个子样本（n=25）通过视频会议完成了功能性能测试。
结果
完成率为 98%（n=1 例死亡）。没有与治疗相关的不良事件报告。Fit2ThriveMB 组的 24 名患者佩戴 Fitbit 的比例为 92.7%，达到目标步数的比例为 53.1%，设定目标步数的比例为 84.6%，在 84 个研究日中使用应用程序的比例为 94.1%。意向性治疗分析显示，活动、QOL 和某些 PRO、社会认知理论构念以及功能性能测试的改善趋势有利于 Fit2ThriveMB 组，而自我效能感和目标设定方面也观察到有利于 Fit2ThriveMB 组的显著效果。然而，一些 PRO 和功能性能的改善有利于对照组（p 值>0.05）。
结论
Fit2ThriveMB 对 MBC 患者是可行且安全的，值得进一步在更大样本量的随机对照试验中进行评估。临床试验注册Clinicaltrials.gov NCT04129346，https://clinicaltrials.gov/ct2/show/NCT04129346。
Zotero 插件