Developing a Comprehensive Exercise Service for Breast Cancer Process
From Scientific Evidence to Practice: Developing a Comprehensive Exercise Service for Breast Cancer Process
1 other identifier
observational
200
1 country
1
Brief Summary
"Moving Together" (Juntas en Movimiento) is a hospital-based, comprehensive, and personalized exercise service designed for women diagnosed with breast cancer. This implementation study aims to evaluate the feasibility, safety, and impact of integrating a free, tailored exercise program into routine clinical care at Hospital Clínico San Carlos in Madrid, Spain. The program offers multiple participation options-supervised in-person, supervised online, autonomous at home, or autonomous at a fitness center-allowing patients to choose based on their preferences, limitations, and treatment phase (pre-surgery, during chemotherapy/radiotherapy, or survivorship). All exercise options are adapted to individual needs and include aerobic and resistance training components. The study uses a real-world implementation science approach, guided by the Consolidated Framework for Implementation Research (CFIR), to assess clinical, physical, and psychological outcomes such as quality of life, cardiorespiratory fitness, muscle strength, body composition, and adherence to physical activity. Data are collected through clinical records, physical assessments, validated questionnaires, and wearable technology. This pioneering initiative in Spain seeks to establish exercise as a standard complementary therapy in oncology care, bridging the gap between scientific evidence and clinical practice, and promoting long-term health and well-being in breast cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2025
CompletedFirst Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
February 2, 2026
January 1, 2026
3 years
November 17, 2025
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-C30
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This instrument includes functional scales, symptom scales, and a global health status scale, all scored from 0 to 100. Higher scores on functional and global health scales indicate better quality of life, whereas higher scores on symptom scales indicate greater symptom burden. The outcome is the change in QLQ-C30 scores from baseline to 4, 8, and 12 months.
Baseline, 4 months, 8 months, and 12 months after enrollment
Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-BR42
HRQoL specific to breast cancer will be assessed using the EORTC Breast Cancer-Specific Module (QLQ-BR42). This questionnaire produces scores ranging from 0 to 100. Higher symptom scores indicate worse symptom burden.
Baseline, 4 months, 8 months, and 12 months after enrollment
Secondary Outcomes (29)
Change in VO2 peak during the cardiorespiratory fitness test
Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.
Change in heart rate response during the cardiorrespiaroty test
Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.
Change in blood lactate concentration during the cardiorespiratory fitness test
Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.
Change in physical activity levels
Continuous monitoring; summarized at baseline, 6 and 12 months
Change in Weight
Baseline, 1 month after surgery, 1 week before chemotherapy start, 1 week after chemotherapy completion, 6 months after surgery, and 5 months after initiation of endocrine/hormonal therapy.
- +24 more secondary outcomes
Study Arms (5)
Supervised In-Person Exercise Group
Participants in this group engage in supervised, in-person exercise sessions at the GO fit Vallehermoso center.
Supervised Online Exercise Group
Participants in this group follow the same structured exercise program as the in-person group but attend sessions via live video conferencing.
Autonomous Home-Based Exercise Group
Participants receive structured exercise guidelines to follow independently at home.
Autonomous Gym-Based Exercise Group
Participants follow individualized exercise guidelines at gym, using gym equipment for strength and aerobic training.
Control Group (Usual Care)
Participants in this group do not engage in any of the structured exercise programs but continue with their standard medical care and follow-up.
Interventions
Participants attend 60-minute, twice-weekly exercise sessions at GO fit Vallehermoso. Sessions include warm-up, aerobic and resistance training, and cool-down. Exercises are tailored to the patient's treatment phase (pre-surgery, during chemotherapy/radiotherapy, or survivorship) and adjusted based on symptoms like fatigue or pain. Heart rate is monitored in real time. Groups are formed by treatment phase and physical capacity to ensure safety and personalization.
Participants follow the same structure as the in-person group but attend sessions via live video conferencing. They receive equipment and training on using the MYZONE app for heart rate monitoring. Sessions are interactive, allowing real-time feedback and social support. This option is designed for patients with mobility, time, or travel limitations.
Participants receive structured exercise guidelines to follow independently at home. Programs include aerobic and strength exercises using bodyweight or household items, with three levels of progression. Training is recommended 1-3 times per week. Participants track activity using a diary and smartphone accelerometer. Programs are adapted to treatment phase and personal capacity.
Participants follow individualized exercise guidelines at the gym, using gym equipment for strength and aerobic training. The program is self-directed but based on the same structure and progression as supervised programs. Activity is tracked via accelerometers and exercise logs. Participants choose this option based on preference and access to gym facilities.
Participants in this group do not receive any structured exercise intervention. They continue with standard medical care and follow-up as prescribed by their oncology team. They undergo the same clinical, physical, and psychological assessments as the intervention groups to allow for comparison of outcomes.
Eligibility Criteria
Women aged 18 years or older diagnosed with any type and stage of breast cancer, receiving care at Hospital Clínico San Carlos (Madrid, Spain). Participants may be at any phase of treatment (pre-surgery, during chemotherapy or radiotherapy, or in the survivorship phase). The study includes a diverse population with varying clinical profiles, physical capacities, and personal circumstances. The exercise program is inclusive and personalized, allowing participation regardless of treatment type or modality, as long as there are no medical contraindications to physical activity.
You may qualify if:
- Women aged 18 years or older.
- Diagnosed with any type and stage of breast cancer.
- Receiving care at Hospital Clínico San Carlos (Madrid, Spain).
- Willing and able to provide informed consent.
- Eligible to participate in physical activity based on clinical evaluation.
You may not qualify if:
- Medical contraindications to physical exercise.
- Severe uncontrolled conditions (whether related to cancer treatment or not).
- Diagnosis of recurrent breast cancer.
- Refusal or inability to sign the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GOfit Vallerhermoso
Madrid, Madrid, 28003, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
February 2, 2026
Study Start
June 6, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
December 1, 2030
Last Updated
February 2, 2026
Record last verified: 2026-01