EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors (NCT07676591) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors
Spain147 participantsStarted 2027-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 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 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.
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.