在内分泌治疗的转移性乳腺癌超重患者中运动项目的可行性:FEMA研究方案。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
May Wissing, Pernille Skovlund, Susanne Drysdale, Ali Amidi, Robert Zachariae, Tinne Laurberg, Signe Borgquist
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引用次数: 0

摘要

背景:许多转移性乳腺癌患者可以活得相对较长,但面临治疗和癌症相关副作用的挑战,如体重增加、身体状况下降和生活质量下降,可能影响生存。特别是,内分泌治疗与体重增加和不良代谢影响的风险增加有关。有必要采取干预措施,以防止播散性乳腺癌患者的副作用。研究发现,运动在改善治疗性患者的生活质量、代谢健康和身体成分方面是有效的,但在转移性患者身上的证据却很少。本研究的目的是评估12周运动干预对接受内分泌治疗的转移性乳腺癌超重患者的可行性,并探讨其对代谢健康、身体成分、身体表现、肥胖相关生物标志物和患者报告结果的潜在影响。方法:FEMA研究是一项随机对照可行性试验,其中21名内分泌治疗的转移性乳腺癌和超重患者将按2:1的比例随机分配到12周的训练计划中,每周进行三次训练(干预),或常规护理(对照组),其中包括标准的临床随访和无结构运动的支持性护理。将根据招聘率、坚持、保留和可接受性评估可行性,采用定量和定性方法收集数据。参与者的经历将通过访谈的方式进行探索,并基于内容分析进行分析。数据收集自血样、生物电阻抗分析、体能测试、血压测量,以及与健康相关的生活质量、应对癌症的自我效能和睡眠质量的有效问卷,以进行探索性分析。讨论:计划中的研究将允许我们确定这种为期12周的运动干预对内分泌治疗的转移性乳腺癌超重患者是否可行,并探索其对代谢健康、身体成分、身体表现、肥胖相关生物标志物和患者报告结果的潜在影响。可行性结果的信息将为未来确定的随机对照试验的设计提供信息。试验注册:回顾性注册于2024年3月6日,ClinicalTrials.gov (NCT06343987)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Feasibility of an exercise program in endocrine-treated metastatic breast cancer patients with overweight: protocol for the FEMA study.

Feasibility of an exercise program in endocrine-treated metastatic breast cancer patients with overweight: protocol for the FEMA study.

Feasibility of an exercise program in endocrine-treated metastatic breast cancer patients with overweight: protocol for the FEMA study.

Background: Many patients with metastatic breast cancer can live relatively long lives but are challenged by treatment- and cancer-related side effects such as weight gain, physical deconditioning, and reduced quality of life, possibly affecting survival. In particular, endocrine treatments are associated with an increased risk of weight gain and adverse metabolic effects. There is a need for interventions to prevent side effects among patients with disseminated breast cancer. Exercise is found to be effective in improving quality of life, metabolic health, and body composition in the curative setting, yet evidence in the metastatic setting is sparse. The aim of this study is to assess feasibility of a 12-week exercise intervention for metastatic breast cancer patients with overweight receiving endocrine therapy and to explore potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers, and patient-reported outcomes.

Methods: The FEMA study is a randomized controlled feasibility trial in which 21 endocrine-treated patients with metastatic breast cancer and overweight will be randomly assigned in a 2:1 ratio to either a 12-week training program with three weekly training sessions (intervention), or usual care (control), which includes standard clinical follow-up and supportive care without structured exercise. Feasibility will be assessed based on recruitment rate, adherence, retention, and acceptability, employing both quantitative and qualitative approaches for data collection. Participants' experiences will be explored by interviews and analyzed based on content analysis. Data are collected from blood samples, bioelectrical impedance analysis, physical performance tests, blood pressure measurements, and validated questionnaires on health-related quality of life, self-efficacy for coping with cancer, and sleep quality for explorative analyses.

Discussion: The planned study will allow us to determine whether this 12-week exercise intervention is feasible in endocrine-treated metastatic breast cancer patients with overweight and explore potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers, and patient-reported outcomes. Information from feasibility outcomes will inform the design of a future definitive randomized controlled trial.

Trial registration: Retrospectively registered on March 6, 2024, at ClinicalTrials.gov (NCT06343987).

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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