Multimodal Exercise and Education Program in Metastatic Breast CancerMostrar más líneas (NCT07693985) | Clinical Trial Compass
CompletedNot Applicable
Multimodal Exercise and Education Program in Metastatic Breast CancerMostrar más líneas
Spain37 participantsStarted 2024-01-12
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Global Health Status/Quality of LifeMostrar más líneas
Timeframe: Baseline and after completion of the 12-week interventionMostrar más líneas