Multimodal Exercise and Education Program in Metastatic Breast CancerMostrar más líneas

NCT07693985 | Completed

• 1 other identifier: MBC_MME01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer-Related Fatigue; Metastatic Breast Cancer; Quality of Life

Keywords

Metastatic breast cancer; Quality of life; Supportive care; Physical exercise; Health education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Multimodal Exercise and Health Education Program

EXPERIMENTAL

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

Interventions

Multimodal Oncology-Based Intervention for Metastatic Breast Cancer OTHER

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.

Multimodal Exercise and Health Education Program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants were women diagnosed with metastatic breast cancer receiving active systemic treatment.Mostrar más líneas
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Carmen García Gomariz

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Health Education

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Sergio Pascual-Solaz

  a. Departament of Medical Oncology, Consorcio Hospital Provincial, Castellón 12005 Valencia, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: Single-group, longitudinal pre-post interventional study. All participants receive the same 12-week community-based multimodal intervention combining supervised physical exercise and health education. Outcomes are assessed before and after completion of the intervention.Mostrar más líneas

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 9, 2026
• Study Start: January 12, 2024
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)