The goal of this clinical trial is to learn if a 12-week hybrid exercise and education program (EmpowerHer) works to improve health-related quality of life in breast cancer survivors aged 35 to 65.
The main questions it aims to answer are:
* Does the EmpowerHer program improve the everyday quality of life of participants? * Does the program lower fatigue, anxiety, and depression while raising physical fitness?
Researchers will compare the EmpowerHer program to usual medical care to see if the program works better to help survivors recover.
Participants will:
* Use a mobile application at home at least twice a week for structured exercise. * Read short educational modules on the mobile application about health after cancer. * Attend weekly in-person motivational group sessions with a program facilitator. * Complete health and physical tests at the start, at 12 weeks, and 3 months later.
Women aged 18-65 years.
History of breast cancer.
Completed primary treatment (surgery, chemotherapy, and/or radiotherapy; adjuvant hormone therapy is permitted).
No evidence of active or metastatic disease at enrolment.
Cognitive impairment preventing safe participation or questionnaire completion.
Uncontrolled medical conditions that contraindicate exercise (e.g., unstable cardiac disease).
Concurrently enrolled in another structured exercise or survivorship study.
Pregnant or breastfeeding.
Parallel
EmpowerHer Hybrid Program
BehavioralA 12-week hybrid physical exercise and health education program. It consists of home-based structured exercise sessions delivered via a dedicated mobile application (minimum of 2 sessions per week) combined with weekly, in-person group motivational and educational sessions led by a trained local facilitator in community settings.
Health-Related Quality of Life (HRQoL)
Evaluated using the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its breast cancer-specific module (EORTC QLQ-BR23). The EORTC QLQ-C30 incorporates a Global Health Status/QoL scale, functional scales, and symptom scales. The QLQ-BR23 incorporates functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss). All scores are linearly transformed to a 0-100 scale. For the Global Health Status and functional scales, a higher score represents a higher/better level of functioning and quality of life. For the symptom scales, a higher score represents a higher/worse level of symptomatology or problems.
Physical Activity Levels
Measured using the International Physical Activity Questionnaire (IPAQ). The primary metric will be weekly minutes of moderate-to-vigorous physical activity (MVPA). Total MET-minutes/week will also be calculated. Higher values indicate greater physical activity engagement.
Lower-Body Muscular Strength (30-second Sit-to-Stand Test)
Assessed using the 30-second Sit-to-Stand test. This test measures the number of times a participant can fully stand up from a seated position on a standard chair (44 cm seat height) and sit down again within a 30-second time limit, keeping their arms folded across their chest. Higher repetitions indicate greater lower-body muscular strength and functional mobility.
Upper-Body Muscular Strength (30-second Arm Curl Test)
Assessed using the 30-second Arm Curl test. Participants are required to perform as many biceps curls as possible in 30 seconds while sitting on a chair, using a 2 kg dumbbell in their dominant hand (with the arm moving through a full range of motion from complete extension to complete flexion). Higher repetitions indicate greater upper-body muscular strength and muscular endurance.
Transitional Mobility and Core Strength (30-second Lie-to-Sit Test)
Assessed using the 30-second Lie-to-Sit test, a functional assessment task designed to evaluate transitional mobility. The test measures the maximum number of repetitions a participant can complete within 30 seconds moving from a fully supine position (lying on a flat treatment table or mat) to a fully upright seated position. Higher repetitions reflect better transitional mobility, trunk control, and core strength.
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University of Valencia
Lead sponsor
European Platform for Sport Innovation (EPSI)
Collaborator
Surpass Sport Systems
Collaborator
Olympiacos SFP
Collaborator
Cluster Sports and Technology (CST)
Collaborator
European Platform for Sport Innovation
Collaborator
Poznań Supercomputing and Networking Center (PCSS)
Collaborator
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