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术前新辅助化疗期间对乳腺癌女性进行康复治疗的可行性随机对照试验:混合方法研究。

A Feasibility Randomized Controlled Trial of Prehabilitation During Neoadjuvant Chemotherapy for Women with Breast Cancer: A Mixed Methods Study.

机构信息

Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.

Department of Anesthesia and Pain Management, University Health Network, Toronto, ON, Canada.

出版信息

Ann Surg Oncol. 2024 Apr;31(4):2261-2271. doi: 10.1245/s10434-023-14851-z. Epub 2024 Jan 13.

Abstract

BACKGROUND

Limited data exist regarding the role of multimodal prehabilitation during neoadjuvant chemotherapy (NACT) for breast cancer. Determining large trial feasibility and identifying signals of prehabilitation benefit are needed.

PATIENTS AND METHODS

We conducted a randomized controlled feasibility trial of multimodal prehabilitation versus usual care during NACT among women diagnosed with non-metastatic breast cancer. Intervention participants received an individualized exercise program, dietetic support, and stress management counseling during NACT. The trial assessed feasibility via rates of recruitment, attrition, adherence, and study-related adverse events. Physical fitness (Six Minute Walk Test, grip strength, anthropometrics) and patient-reported outcomes were assessed at baseline, after NACT completion, and 6 months after surgery as exploratory outcomes, and analyzed using linear mixed effects models. Qualitative data were collected from a subsample to understand feasibility and acceptability of prehabilitation.

RESULTS

A total of 72 participants were enrolled from the 123 eligible patients (recruitment rate of 53%). There was a 13% attrition rate and no intervention-related adverse events. Participants in the prehabilitation group had better 6-min walk distance at the post-chemotherapy timepoint [between group difference of 49.43 m, 95% confidence interval (CI) - 118.1, 19.2] and at the post-surgery timepoint (27.3, 95% CI -96.8, 42.2) compared with the control group. Prehabilitation participants reported better quality of life, less fatigue, and improved physical activity levels compared with usual care participants. Interviews revealed that the intervention had a positive impact on the treatment experience.

CONCLUSIONS

This study demonstrated feasibility and improvement in physical and psychosocial outcomes. Larger trials assessing intervention efficacy to confirm indications of prehabilitation benefit are warranted.

摘要

背景

关于新辅助化疗(NACT)期间多模式预康复在乳腺癌中的作用,相关数据有限。需要确定大型试验的可行性并确定预康复益处的信号。

患者和方法

我们对接受非转移性乳腺癌诊断的女性进行了一项 NACT 期间多模式预康复与常规护理的随机对照可行性试验。干预组在 NACT 期间接受个体化运动方案、饮食支持和压力管理咨询。该试验通过招募率、失访率、依从性和与研究相关的不良事件评估可行性。在基线、NACT 完成后和手术后 6 个月评估身体机能(六分钟步行测试、握力、人体测量学)和患者报告的结果作为探索性结果,并使用线性混合效应模型进行分析。从亚组收集定性数据,以了解预康复的可行性和可接受性。

结果

从 123 名符合条件的患者中共有 72 名患者入组(招募率为 53%)。失访率为 13%,无干预相关不良事件。预康复组在化疗后时间点的 6 分钟步行距离更好[组间差异 49.43 米,95%置信区间(CI)-118.1,19.2]和手术后时间点(27.3,95%CI-96.8,42.2),与对照组相比。与常规护理组相比,预康复组患者报告的生活质量更高、疲劳感更低、体力活动水平更高。访谈显示,该干预对治疗体验产生了积极影响。

结论

本研究表明可行性和身体和心理社会结果的改善。需要更大规模的试验评估干预效果,以确认预康复益处的指征。

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