Breast CancerCancer SurvivorsQuality of LifeExercise TherapySocial SupportMobile Applications
Investigational drug(s) / intervention(s)
EmpowerHer Hybrid Program
EmpowerHer Hybrid Program: A 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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Able to provide informed consent and communicate in the local language.
* Own and are able to use a smartphone.
* Willing to engage in the exercise program.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Health-Related Quality of Life (HRQoL) — Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24) 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.
Trial sites (1)
Facility
City
Region
Status
Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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