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Digital Tool for Psychological Support in Women With Breast Cancer

NCT07169539 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-11

No results posted yet for this study

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?

Conditions

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

Sponsors & Collaborators

  • Hospital Costa del Sol

    lead OTHER

Principal Investigators

  • Irene Zarcos-Pedrinaci, PhD · Hospital Universitario Costa del Sol

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-03-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07169539 on ClinicalTrials.gov