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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Metastatic Breast Cancer; Cancer-Related Fatigue
• Intervention / Treatment: Other: Multimodal Oncology-Based Intervention for Metastatic Breast Cancer

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Carmen García Gomariz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Health Status/Quality of LifeMostrar 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical FunctioningMostrar 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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Sergio Pascual-Solaz, a. Departament of Medical Oncology, Consorcio Hospital Provincial, Castellón 12005 Valencia, Spain

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Actual): December 17, 2025
• Study Completion (Actual): December 17, 2025

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Metastatic breast cancer; Physical exercise; Health education; Supportive care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Breast Neoplasms; Motor Activity; Health Education
• Other Study ID Numbers: MBC_MME01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No