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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Global Health Status/Quality of LifeMostrar más líneas
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was applied. Due to the nature of the community-based physical exercise and health education intervention, participants and intervention providers could not be blinded to group assignment. Outcome assessments were performed before and after the intervention.Mostrar más líneas
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with metastatic breast cancer.
- •Receiving active systemic treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Able to ambulate independently.
- •Able and willing to participate in the multimodal intervention program.
- •Provided written informed consent.
排除标准
- •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.
结局指标
主要结局
Change in Global Health Status/Quality of LifeMostrar más líneas
时间窗: 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
次要结局
- Change in Physical FunctioningMostrar más líneas(Baseline and after completion of the 12-week interventionMostrar más líneas)
- Change in Role FunctioningMostrar más líneas(Baseline and after completion of the 12-week interventionMostrar más líneas)
- Change in Emotional FunctioningMostrar más líneas(Baseline and after completion of the 12-week interventionMostrar más líneas)
- Change in Cancer-Related FatigueMostrar más líneas(Baseline and after completion of the 12-week interventionMostrar más líneas)
- Change in Multidimensional FatigueMostrar más líneas(Baseline and after completion of the 12-week intervention)
- Change in Breast Cancer-Specific Quality of LifeMostrar más líneas(Baseline and after completion of the 12-week interventionMostrar más líneas)
研究者
CARMEN GARCÍA GOMARIZ
Clinical professor
University of Valencia