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.

IF 3 3区医学 Q2 ONCOLOGY

Breast Cancer Research and Treatment Pub Date : 2024-11-01 Epub Date: 2024-07-16 DOI:10.1007/s10549-024-07432-5

Siobhan M Phillips, Julia Starikovsky, Payton Solk, Ria Desai, Jean M Reading, Kristina Hasanaj, Shirlene D Wang, Erin Cullather, Jungwha Lee, Jing Song, Bonnie Spring, William Gradishar

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引用次数: 0

Abstract

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.

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Fit2ThriveMB 试点体育锻炼促进干预对转移性乳腺癌患者的体育锻炼和患者报告结果的可行性和初步效果。

目的：针对转移性乳腺癌（MBC）患者的体育锻炼研究十分有限。本研究考察了 Fit2ThriveMB 这种量身定制的移动医疗干预措施的可行性和潜在益处：将运动量不足的 MBC 患者（n = 49）按 1:1 随机分配到 Fit2ThriveMB（Fit2ThriveMB 应用程序、Fitbit 和每周辅导电话）或健康生活方式关注对照组（Cancer.Net 应用程序和每周电话），为期 12 周。Fit2ThriveMB旨在通过一种根据每日症状评级和步数目标实现情况量身定制的算法来增加每日步数。主要结果是可行性，即完成率≥ 80%。次要可行性指标包括达到每日步数目标和佩戴 Fitbit ≥ 70% 的研究天数、保真度、对干预特征的坚持度和安全性。次要结果包括体力活动、久坐时间、患者报告结果（PROs）、与健康相关的生活质量（QOL）和社会认知理论结构。一个子样本（n = 25）通过视频会议完成了功能表现测试：结果：完成率为 98%（n = 1 例死亡）。无相关不良事件报告。Fit2ThriveMB 参与者（n = 24）佩戴 Fitbit 的比例为 92.7%，达到步数目标的比例为 53.1%，设定步数目标的比例为 84.6%，在 84 个研究日中使用应用程序的比例为 94.1%。意向治疗分析表明，Fit2ThriveMB 组在活动量、QOL 和一些 PROs、社会认知理论构建和功能表现测试方面均有改善趋势。在自我效能和目标设定方面，观察到了有利于 Fit2ThriveMB 的显著效果。然而，对照组在某些 PROs 和功能表现改善方面更有优势（P 值 > 0.05）：结论：Fit2ThriveMB 对乳腺增生症患者是可行且安全的，值得在样本量更大的随机对照试验中进行进一步评估。注册 Clinicaltrials.gov NCT04129346，https://clinicaltrials.gov/ct2/show/NCT04129346。

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来源期刊

Breast Cancer Research and Treatment 医学-肿瘤学

CiteScore

6.80

自引率

2.60%

发文量

342

审稿时长

1 months

期刊介绍： Breast Cancer Research and Treatment provides the surgeon, radiotherapist, medical oncologist, endocrinologist, epidemiologist, immunologist or cell biologist investigating problems in breast cancer a single forum for communication. The journal creates a "market place" for breast cancer topics which cuts across all the usual lines of disciplines, providing a site for presenting pertinent investigations, and for discussing critical questions relevant to the entire field. It seeks to develop a new focus and new perspectives for all those concerned with breast cancer.