A Virtual Mind-Body Exercise Program During Breast Radiation: Results From a Randomized Controlled Basket Trial

IF 7.4 1区 医学 Q1 ONCOLOGY
Erin F. Gillespie MD, MPH , Sierra Silverwood MD , Kaitlyn Lapen MD , Nicholas P. Verdini MD , Karolina Bryl PhD , Raymond E. Baser PhD , Atif J. Khan MD , Jun J. Mao MD, MSCE
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引用次数: 0

Abstract

Purpose

National guidelines recommend fitness and mind-body exercise to reduce cancer-related fatigue, but substantial barriers to implementation exist. Virtual programs offer a scalable approach to address this gap. This study aims to evaluate the efficacy of a virtual fitness and mind-body exercise program (Integrative Medicine at Home [IM@Home]) in reducing fatigue in patients undergoing radiation therapy (RT) for breast cancer.

Methods and Materials

A prospective randomized controlled patient-reported outcome basket clinical trial was conducted. Patients undergoing breast RT who reported moderate or greater fatigue were randomly assigned 1:1 ratio to either IM@Home, which provided live virtual fitness and mind-body exercise classes, or enhanced usual care (EUC). The primary outcome, fatigue, was measured using the total Brief Fatigue Inventory, a composite score including severity and impact on daily functioning, weekly over 12 weeks. Secondary outcomes included the Insomnia Severity Index, Edmonton Symptom Assessment Scale, and Hospital Anxiety and Depression Scale collected every 4 weeks. Statistical analysis included linear mixed models to compare group differences over time using a statistical significance threshold of P < .05.

Results

Among 73 enrolled patients, 35 were randomly assigned to IM@Home and 38 to EUC. At week 12, patients in the IM@Home group had significantly less fatigue compared to those in the EUC group (2.06 vs 2.79, P = .009). Compared to EUC, patients in the IM@Home group showed greater reductions in insomnia (P = .005), symptom distress (P = .013), and depression (P = .04), but not anxiety (P = .14).

Conclusions

The IM@Home program significantly reduced fatigue and comorbid symptoms among women with breast cancer undergoing RT. Future research is needed to confirm these findings, explore mechanisms of the observed benefit, and evaluate scalability as well as barriers and facilitators to implementation.
乳房放疗期间的虚拟身心锻炼计划:来自随机对照篮子试验的结果。
背景:国家指南建议通过健身和身心锻炼来减少癌症相关的疲劳,但在实施方面存在实质性障碍。虚拟程序提供了一种可扩展的方法来解决这一差距。本研究旨在评估虚拟健身和身心锻炼计划(家庭综合医学,IM@Home)在减少乳腺癌放射治疗(RT)患者疲劳方面的功效。方法:采用前瞻性随机对照患者报告预后(PRO)篮子临床试验。接受乳房RT的患者报告有中度或更严重的疲劳,随机按1:1的比例分配到提供实时虚拟健身和身心锻炼课程的IM@Home或增强常规护理(EUC)。主要结果是疲劳,使用总短暂疲劳量表(BFI)来测量,BFI是一种综合评分,包括严重程度和对日常功能的影响,每周持续12周。次要结局包括每4周收集一次的失眠严重程度指数(ISI)、埃德蒙顿症状评估量表(ESAS)和医院焦虑抑郁量表(HADS)。统计学分析采用线性混合模型,采用p < 0.05的统计学显著性阈值比较组间时间差异。结果:在73名入组患者中,35名随机分配到IM@Home, 38名随机分配到EUC。在第12周,IM@Home组患者的疲劳程度明显低于EUC组(2.06 vs 2.79, p=0.009)。与EUC相比,IM@Home组患者在失眠(p=0.005)、症状困扰(p=0.013)和抑郁(p=0.04)方面表现出更大的减少,但没有焦虑(p=0.14)。结论:IM@Home项目显著减少了接受rt治疗的乳腺癌妇女的疲劳和共病症状。需要进一步的研究来证实这些发现,探索观察到的益处的机制,评估可扩展性以及实施的障碍和促进因素。临床试验:政府标识符:NCT05053230。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
11.00
自引率
7.10%
发文量
2538
审稿时长
6.6 weeks
期刊介绍: International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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