Digital Tool for Psychological Support in Women With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SerenApp Digital Psychological Intervention.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SerenApp Project: Protocol for a Pilot Study and Co-Creation of a Digital Tool for Psychological Support in Women Under Follow-Up and Breast Cancer Survivors
Overview
This study will design, test, and evaluate SerenApp, a digital health tool created to support women after completing treatment for breast cancer. Many women live for many years after breast cancer, but a large number continue to experience emotional difficulties such as anxiety, sadness, stress, or fear of the cancer coming back. These problems can strongly affect quality of life and are often not addressed during routine medical visits. SerenApp is being developed as a safe, easy-to-use mobile application that provides psychological support and practical resources to help breast cancer survivors manage these challenges. What makes this project different is that the app will be created together with patients and healthcare professionals, to ensure that it responds to real needs and is adapted to the public health system in Spain. The main questions of the study are: Can SerenApp help women feel less anxious, depressed, or stressed and improve their overall quality of life? Will women and professionals find the app useful, acceptable, and easy to use? Could this digital tool reduce the need for additional healthcare resources and be cost-effective for the health system?
Detailed description
The project has two main parts:
Co-creation phase:
Women who have had breast cancer and healthcare providers (such as oncologists, nurses, and psychologists) will participate in workshops and group discussions.
They will share their experiences, identify needs, and help design the functions and content of the app.
This ensures that the final product is adapted to what patients and professionals really want and need.
Pilot clinical study:
Women who have finished their breast cancer treatment will be invited to join the study.
Participants will be randomly assigned to one of two groups:
Intervention group: Women will use SerenApp for 8 weeks. The app includes exercises, information, and resources to help manage emotions, improve coping strategies, and feel more in control of their health.
Control group: Women will continue with their usual follow-up care.
All participants will complete questionnaires at the beginning and end of the study to measure emotional well-being, quality of life, satisfaction with care, and use of healthcare services.
After the 8 weeks, some women will take part in group interviews to share their opinions and experiences using the app.
By combining patient and professional input with scientific evaluation, this project will test whether SerenApp is a feasible and effective way to provide psychological support to breast cancer survivors. If it works as expected, SerenApp could become a valuable tool for women, families, and health services, offering accessible, evidence-based support to improve emotional well-being after cancer.
Interventions
- Device SerenApp Digital Psychological Intervention
SerenApp is a co-created, personalized digital intervention designed to support the mental health of women in breast cancer follow-up or survivorship. The app includes modules targeting stress coping, anxiety, and depression, delivered via smartphone or computer. Content and functionalities were developed collaboratively with patients and healthcare professionals, ensuring usability, clinical relevance, and adherence to regulatory and ethical standards. The intervention is intended for self-guid
Primary outcome measures
- Change in Stress Coping Strategies [Time frame: Baseline (T0) and 8 weeks (T1)]
- Change in Anxiety Symptoms [Time frame: Baseline (T0, before intervention) and 8 weeks post-intervention (T1)]
- Change in Depressive Symptoms [Time frame: Baseline (T0) and 8 weeks (T1).]
Secondary outcome measures (3)
- Change in Health-Related Quality of Life [Time frame: Baseline (T0) and 8 weeks (T1)]
- Usability of SerenApp [Time frame: 8 weeks (T1, post-intervention only).]
- Satisfaction with Care [Time frame: 8 weeks (T1)]
Eligibility criteria
Inclusion criteria
Women aged ≥18 years.
History of breast cancer with completion of primary treatment (surgery, chemotherapy, and/or radiotherapy), currently in follow-up.
Access to a smartphone or tablet with internet connection.
Ability to understand and provide written informed consent.
Sufficient knowledge of Spanish to use the app and complete questionnaires.
Exclusion criteria
Current recurrence or metastatic breast cancer.
Severe cognitive impairment or psychiatric disorder that may interfere with participation (e.g., psychosis, severe dementia).
Concurrent participation in another psychosocial intervention study.
Lack of access to digital devices or inability to use mobile applications.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Spain · 2 centers
- Hospital Universitario Costa del Sol — Marbella
- Servicio Canario de la Salud — Santa Cruz de Tenerife
Identifiers
NCT: NCT07169539 · PI24/01193