Metastatic Breast CancerMBC_MMENCT07693985
Multimodal Exercise and Education Program in Metastatic Breast CancerMostrar más líneas
A study testing Multimodal Oncology-Based Intervention for Metastatic Breast Cancer in people with Metastatic Breast Cancer and Cancer-Related Fatigue, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, Cancer-Related Fatigue, Quality of Life
- What is being tested?
- Multimodal Oncology-Based Intervention for Metastatic Breast Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2024to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Multimodal Oncology-Based Intervention for Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer, Quality of life, Supportive care, Physical exercise, Health education
- Medical subject headings
- Breast Neoplasms, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Oncology-Based Intervention for Metastatic Breast CancerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multimodal Oncology-Based Intervention for Metastatic Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and after completion of the 12-week interventionMostrar más líneas
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and after completion of the 12-week interventionMostrar más líneas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start12 Jan 2024
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARMEN GARCÍA GOMARIZ, University of Valencia
- Investigators
- Sergio Pascual-Solaz, Principal investigator, a. Departament of Medical Oncology, Consorcio Hospital Provincial, Castellón 12005 Valencia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693985
- Sponsor's protocol ID
- MBC_MME01
- Acronym
- MBC_MME
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07693985
- Acronym / sponsor ID
- MBC_MME / MBC_MME01
- Keywords
- Metastatic breast cancer, Quality of life, Supportive care, Physical exercise, Health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Multimodal Exercise and Health Education Program | Experimental | Other: Multimodal Oncology-Based Intervention for Metastatic Breast CancerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Oncology-Based Intervention for Metastatic Breast CancerParticipants 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. | Other | Multimodal Exercise and Health Education Program |
Primary outcome
Change in Global Health Status/Quality of LifeMostrar más líneas
Time frame: 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
6 secondary outcomes
Change in Physical FunctioningMostrar más líneas
Time frame: Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Role FunctioningMostrar más líneas
Time frame: Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Emotional FunctioningMostrar más líneas
Time frame: Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Cancer-Related FatigueMostrar más líneas
Time frame: Baseline and after completion of the 12-week interventionMostrar más líneas
Change in Multidimensional FatigueMostrar más líneas
Time frame: Baseline and after completion of the 12-week intervention
Change in Breast Cancer-Specific Quality of LifeMostrar más líneas
Time frame: Baseline and after completion of the 12-week interventionMostrar más líneas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Pascual-Solaz principal investigator
a. Departament of Medical Oncology, Consorcio Hospital Provincial, Castellón 12005 Valencia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Oncology-Based Intervention for Metastatic Breast Cancer in people with Metastatic Breast Cancer and Cancer-Related Fatigue, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Health Status/Quality of LifeMostrar más líneas (time frame: Baseline and after completion of the 12-week interventionMostrar más líneas). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.