NCT07169539

Digital Tool for Psychological Support in Women With Breast Cancer

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Hospital Costa del Sol · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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-guided use over eight weeks, with monitoring of engagement, completion, and user satisfaction.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-03-31
• Completion: 2027-12-31
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

2 sites across 1 country: Spain