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Multimodal Exercise and Education Program in Metastatic Breast CancerMostrar más líneas (MBC_MME)

2026年7月6日 更新者：CARMEN GARCÍA GOMARIZ、University of Valencia

Effects of a Multimodal Community-based Intervention Combining Physical Exercise and Health Education Workshops on Quality of Life in Women With Metastatic Breast Cancer: a Longitudinal Pre-post Study.

This longitudinal pre-post study evaluates the effects of a 12-week community-based multimodal intervention combining supervised physical exercise and health education in women with metastatic breast cancer receiving active systemic treatment. The intervention includes Nordic walking, Tai Chi, and structured health education workshops. The main outcomes are changes in health-related quality of life and cancer-related fatigue, assessed before and after the intervention using validated EORTC questionnaires.Mostrar más líneas

研究概览

地位

完全的

条件

干预/治疗

详细说明

Women with metastatic breast cancer receiving active systemic treatment frequently experience impaired health-related quality of life, cancer-related fatigue, and limitations in daily functioning. Supportive care strategies that combine physical exercise, education, and symptom self-management may help improve these outcomes, although evidence in women living with metastatic breast cancer remains limited.

This study is a longitudinal pre-post intervention study conducted in women with metastatic breast cancer receiving active systemic treatment. Eligible participants are women with metastatic breast cancer, preserved functional status, and the ability to ambulate independently. Participants are assessed at baseline and after completion of the intervention.

The intervention lasts 12 weeks and consists of a community-based multimodal program combining supervised physical exercise and health education. The exercise component includes two 60-minute supervised sessions per week: one session of Nordic walking and one session of Tai Chi. Nordic walking sessions are supervised by a physiotherapist, and Tai Chi sessions are led by a trained instructor. Exercise sessions are adapted to participants' physical capacity and clinical condition.

In addition to the exercise component, participants attend structured health education workshops throughout the program. These sessions address topics relevant to women with metastatic breast cancer, including general aspects of metastatic breast cancer, systemic treatments and toxicity management, the benefits of physical exercise, nutrition and supplementation, sleep hygiene, emotional regulation, communication with the social environment, and aesthetic care during cancer treatment.

Health-related quality of life is assessed using the EORTC QLQ-C30 and the breast cancer-specific EORTC QLQ-BR45 questionnaires. Cancer-related fatigue is assessed using the EORTC QLQ-FA12 questionnaire. The study evaluates changes in global health status, functional domains, fatigue dimensions, and selected breast cancer-specific symptom and functional domains before and after the intervention.

The aim of the study is to determine whether a supervised, community-based multimodal program combining physical exercise and health education is associated with improvements in quality of life, functioning, and fatigue-related outcomes in women with metastatic breast cancer receiving active systemic treatment.

研究类型

介入性

注册 (实际的)

37

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
      • Valencia、西班牙、46010
        • Carmen García Gomariz

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Women diagnosed with metastatic breast cancer.
  • Receiving active systemic treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Able to ambulate independently.
  • Able and willing to participate in the multimodal intervention program.
  • Provided written informed consent.

Exclusion Criteria:

  • Moderate or severe cognitive impairment.
  • Severe psychiatric illness.
  • Sensory impairment preventing participation in the intervention or assessments.
  • Chronic disabling conditions limiting participation in the planned activities.
  • Unstable bone metastases, according to medical judgment, associated with risk of fragility fracture.
  • Cardiac or respiratory disease limiting the capacity to perform physical activity.
  • Any other medical condition that, in the opinion of the treating oncologist, contraindicated participation in the program.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Multimodal Exercise and Health Education Program
Participants receive a 12-week community-based multimodal intervention combining supervised physical exercise and health education. The exercise component includes one weekly Nordic walking session and one weekly Tai Chi session, each lasting 60 minutes. In addition, participants attend structured health education workshops addressing topics related to metastatic breast cancer, systemic treatment and toxicity management, physical exercise, nutrition, sleep hygiene, emotional regulation, communication, and aesthetic care during cancer treatment.
其他：Multimodal Oncology-Based Intervention for Metastatic Breast Cancer
Participants receive a 12-week community-based multimodal oncology intervention combining supervised physical exercise and health education. The exercise component consists of one weekly Nordic walking session and one weekly Tai Chi session, each lasting 60 minutes. In addition, participants attend structured health education workshops covering metastatic breast cancer, systemic treatment and toxicity management, safe physical exercise, nutrition, sleep hygiene, emotional regulation, communication, and aesthetic care during cancer treatment. The intervention aims to promote physical and emotional well-being, support self-management, and improve quality of life.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Global Health Status/Quality of LifeMostrar más líneas
大体时间：Baseline and after completion of the 12-week interventionMostrar más líneas
Change in global health status/quality of life assessed using the EORTC QLQ-C30 global health status scale. Scores are transformed to a 0-100 scale, with higher scores indicating better global health status and quality of life.Mostrar más líneas
Baseline and after completion of the 12-week interventionMostrar más líneas

次要结果测量

结果测量
措施说明
大体时间
Change in Physical FunctioningMostrar más líneas
大体时间：Baseline and after completion of the 12-week interventionMostrar más líneas
Change in physical functioning assessed using the EORTC QLQ-C30 physical functioning scale. Scores are transformed to a 0-100 scale, with higher scores indicating better physical functioning.Mostrar más líneas
Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Role FunctioningMostrar más líneas
大体时间：Baseline and after completion of the 12-week interventionMostrar más líneas
Change in role functioning assessed using the EORTC QLQ-C30 role functioning scale. Scores are transformed to a 0-100 scale, with higher scores indicating better role functioning.Mostrar más líneas
Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Emotional FunctioningMostrar más líneas
大体时间：Baseline and after completion of the 12-week interventionMostrar más líneas
Change in emotional functioning assessed using the EORTC QLQ-C30 emotional functioning scale. Scores are transformed to a 0-100 scale, with higher scores indicating better emotional functioning.
Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Cancer-Related FatigueMostrar más líneas
大体时间：Baseline and after completion of the 12-week interventionMostrar más líneas
Change in fatigue assessed using the fatigue symptom scale of the EORTC QLQ-C30. Scores are transformed to a 0-100 scale, with higher scores indicating greater fatigue symptom burden.Mostrar más líneas
Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Multidimensional FatigueMostrar más líneas
大体时间：Baseline and after completion of the 12-week intervention
Change in multidimensional cancer-related fatigue assessed using the EORTC QLQ-FA12 questionnaire, including physical fatigue, emotional fatigue, cognitive fatigue, interference with daily life, and social dimension. Scores are transformed to a 0-100 scale, with higher scores indicating greater fatigue or impairment.Mostrar más líneas
Baseline and after completion of the 12-week intervention
Change in Breast Cancer-Specific Quality of LifeMostrar más líneas
大体时间：Baseline and after completion of the 12-week interventionMostrar más líneas
Change in breast cancer-specific quality of life assessed using selected domains of the EORTC QLQ-BR45 questionnaire, including body image, future perspective, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, and skin and mucosal symptoms. Scores are transformed to a 0-100 scale. Higher scores indicate better functioning in functional scales and greater symptom burden in symptom scales.Mostrar más líneas
Baseline and after completion of the 12-week interventionMostrar más líneas

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Valencia

调查人员

  • 首席研究员：Sergio Pascual-Solaz、a. Departament of Medical Oncology, Consorcio Hospital Provincial, Castellón 12005 Valencia, Spain

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月12日

初级完成 (实际的)

2025年12月17日

研究完成 (实际的)

2025年12月17日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MBC_MME01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data supporting the findings of this study may be made available to qualified researchers upon reasonable request to the corresponding author. Shared data may include baseline sociodemographic and clinical variables, intervention attendance, and EORTC QLQ-C30, QLQ-BR45, and QLQ-FA12 scores at baseline and post-intervention. Data sharing will be subject to ethical and data protection requirements and will require approval of a research proposal and a data access agreement.Mostrar más líneas

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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