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移动支持小组对乳腺癌幸存者的困扰和身体活动的影响:随机、平行组、开放标签、对照试验。

The Impact of a Mobile Support Group on Distress and Physical Activity in Breast Cancer Survivors: Randomized, Parallel-Group, Open-Label, Controlled Trial.

机构信息

Lee Business School, University of Nevada Las Vegas, Las Vegas, NV, United States.

Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.

出版信息

J Med Internet Res. 2023 Aug 7;25:e47158. doi: 10.2196/47158.

Abstract

BACKGROUND

While mobile health apps have demonstrated their potential in revolutionizing health behavior changes, the impact of a mobile community built on these apps on the level of physical activity and mental well-being in cancer survivors remains unexplored.

OBJECTIVE

In this randomized controlled trial, we examine the effects of participation in a mobile health community specifically designed for breast cancer survivors on their physical activity levels and mental distress.

METHODS

We performed a single-center, randomized, parallel-group, open-label, controlled trial. This trial enrolled women between 20 and 60 years of age with stage 0 to III breast cancer, an Eastern Cooperative Oncology Group performance status of 0, and the capability of using their own smartphone apps. From January 7, 2019, to April 17, 2020, a total of 2,616 patients were consecutively screened for eligibility after breast cancer surgery. Overall, 202 patients were enrolled in this trial, and 186 patients were randomly assigned (1:1) to either the intervention group (engagement in a mobile peer support community using an app for tracking steps; n=93) or the control group (using the app for step tracking only; n=93) with a block size of 10 without stratification. The mobile app provides a visual interface of daily step counts, while the community function also provides rankings among its members and regular notifications encouraging physical activity. The primary end point was the rate of moderate to severe distress for the 24-week study period, measured through an app-based survey using the Distress Thermometer. The secondary end point was the total weekly steps during the 24-week period.

RESULTS

After excluding dropouts, 85 patients in the intervention group and 90 patients in the control group were included in the analysis. Multivariate analyses showed that patients in the intervention group had a significantly lower degree of moderate to severe distress (B=-0.558; odds ratio 0.572; P<.001) and a higher number of total weekly step counts (B=0.125; rate ratio 1.132; P<.001) during the 24-week period.

CONCLUSIONS

Engagement in a mobile app-based patient community was effective in reducing mental distress and increasing physical activity in breast cancer survivors.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03783481; https://classic.clinicaltrials.gov/ct2/show/NCT03783481.

摘要

背景

移动健康应用程序在改变健康行为方面具有巨大潜力,但是由这些应用程序构建的移动社区对癌症幸存者的身体活动水平和心理健康的影响仍有待探索。

目的

在这项随机对照试验中,我们研究了专门为乳腺癌幸存者设计的移动健康社区对其身体活动水平和心理困扰的影响。

方法

我们进行了一项单中心、随机、平行组、开放性、对照试验。该试验纳入了年龄在 20 岁至 60 岁之间、东部肿瘤协作组体能状态为 0 级、有能力使用自己智能手机应用程序的 0 期至 III 期乳腺癌女性患者。2019 年 1 月 7 日至 2020 年 4 月 17 日,在乳腺癌手术后,共有 2616 例患者连续筛查入组条件。共有 202 例患者入组该试验,186 例患者随机分配(1:1)至干预组(使用应用程序跟踪步数的移动同伴支持社区参与;n=93)或对照组(仅使用应用程序跟踪步数;n=93),分组大小为 10,无分层。移动应用程序提供了日常步数的可视化界面,社区功能还提供了成员排名和定期通知,以鼓励身体活动。主要终点是 24 周研究期间中度至重度困扰的发生率,通过基于应用程序的调查使用困扰温度计进行测量。次要终点是 24 周期间每周的总步数。

结果

排除脱落患者后,干预组 85 例患者和对照组 90 例患者纳入分析。多变量分析显示,干预组患者的中度至重度困扰程度显著降低(B=-0.558;优势比 0.572;P<.001),每周总步数显著增加(B=0.125;率比 1.132;P<.001)。

结论

参与基于移动应用程序的患者社区可有效减轻乳腺癌幸存者的心理困扰,增加身体活动。

试验注册

ClinicalTrials.gov NCT03783481;https://classic.clinicaltrials.gov/ct2/show/NCT03783481.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f79c/10442738/2fd208790ed6/jmir_v25i1e47158_fig1.jpg

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