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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Valencia, España, 46010
- Carmen García Gomariz
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Global Health Status/Quality of LifeMostrar más líneas
Periodo de tiempo: Baseline and after completion of the 12-week interventionMostrar más líneas
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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
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Baseline and after completion of the 12-week interventionMostrar más líneas
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Physical FunctioningMostrar más líneas
Periodo de tiempo: Baseline and after completion of the 12-week interventionMostrar más líneas
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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
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Baseline and after completion of the 12-week interventionMostrar más líneas
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Change in Role FunctioningMostrar más líneas
Periodo de tiempo: Baseline and after completion of the 12-week interventionMostrar más líneas
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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
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Baseline and after completion of the 12-week interventionMostrar más líneas
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Change in Emotional FunctioningMostrar más líneas
Periodo de tiempo: Baseline and after completion of the 12-week interventionMostrar más líneas
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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.
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Baseline and after completion of the 12-week interventionMostrar más líneas
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Change in Cancer-Related FatigueMostrar más líneas
Periodo de tiempo: Baseline and after completion of the 12-week interventionMostrar más líneas
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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
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Baseline and after completion of the 12-week interventionMostrar más líneas
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Change in Multidimensional FatigueMostrar más líneas
Periodo de tiempo: Baseline and after completion of the 12-week intervention
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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
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Baseline and after completion of the 12-week intervention
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Change in Breast Cancer-Specific Quality of LifeMostrar más líneas
Periodo de tiempo: Baseline and after completion of the 12-week interventionMostrar más líneas
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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
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Baseline and after completion of the 12-week interventionMostrar más líneas
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sergio Pascual-Solaz, a. Departament of Medical Oncology, Consorcio Hospital Provincial, Castellón 12005 Valencia, Spain
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Comportamiento
- Enfermedades de la piel y del tejido conectivo
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Intervenciones de adherencia
- Adherencia a la medicación
- Neoplasias de mama
- Actividad del motor
- Educación para la salud
Otros números de identificación del estudio
- MBC_MME01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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