From Scientific Evidence to Practice: Developing a Comprehensive Exercise Service for Breast Cancer Process
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-C30
研究概览
简要总结
"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.
详细描述
"Moving Together" (Juntas en Movimiento) is an implementation research project that evaluates the integration of a comprehensive, free, and personalized exercise service into the clinical care of women with breast cancer. The service is embedded within the Breast Unit of Hospital Clínico San Carlos (Madrid, Spain) and is developed in collaboration with King Juan Carlos University and GO fit Vallehermoso.
The program is designed to be inclusive and adaptable, offering four participation modalities:
- Supervised in-person sessions at a fitness center.
- Supervised online sessions via video conferencing.
- Autonomous home-based training with structured guidelines.
- Autonomous training at a gym with tailored routines.
Patients can join the program at any stage of their cancer journey-before surgery, during chemotherapy or radiotherapy, or in the survivorship phase. The exercise protocols are adapted to each phase and personalized based on clinical status, physical capacity, preferences, and daily symptoms. Supervised sessions include real-time heart rate monitoring and are delivered in small groups to foster social support.
The implementation follows the CFIR model, analyzing internal and external factors that influence adoption, sustainability, and scalability. The program is supported by interdisciplinary collaboration among oncologists, gynecologists, exercise scientists, and clinical staff. Healthcare professionals receive specific training to promote exercise as part of cancer care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Autonomous Home-Based Exercise Group
Participants receive structured exercise guidelines to follow independently at home.
干预措施: Home-Based Autonomous Exercise Program (Other)
Supervised In-Person Exercise Group
Participants in this group engage in supervised, in-person exercise sessions at the GO fit Vallehermoso center.
干预措施: Supervised in-person exercise training (Other)
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.
干预措施: Supervised Online Exercise Training (Other)
Autonomous Gym-Based Exercise Group
Participants follow individualized exercise guidelines at gym, using gym equipment for strength and aerobic training.
干预措施: Gym-Based Autonomous Exercise Program (Other)
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.
干预措施: Usual Care Without Structured Exercise (Other)
结局指标
主要结局
Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-C30
时间窗: Baseline, 4 months, 8 months, and 12 months after enrollment
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.
Change in Health-Related Quality of Life (HRQoL) measured by the EORTC QLQ-BR42
时间窗: Baseline, 4 months, 8 months, and 12 months after enrollment
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.
次要结局
- 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.)
- Change in Musculoskeletal Mass(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 Body Fat Mass(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 Body Mass Index(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 Percentage of Body Fat (% Body Fat)(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 Visceral Fat Level(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 Extracellular Water(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 Phase Angle(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 Waist Circumference(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 Hip Circumference(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 Lower Body Functional Strength(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 Upper Body Strength(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 Functional Mobility, Dynamic balance and Risk of falls(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 Static Balance(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 Upper Body Flexibility(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 Squat Maximal Strength(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 Chest Press Maximal Strength(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 Incline Row Maximal Strength(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 Squat Power(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 Chess Press Power(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 Incline Row Power(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.)
- Number of exercise sessions attended per participant in each exercise program(Throughout the intervention period)
- Compliance With Prescribed Exercise Routines(Throughout the intervention period.)
- Number of participants who dropout participation in each exercise program(Throughout the intervention period.)
- Modification of the Prescribed Exercise Program(Throughout the intervention period)