Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SerenApp Digital Psychological Intervention | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SerenApp Intervention
- description
- Participants in this group will receive access to SerenApp for 8 weeks. SerenApp is a co-designed digital mental health application for breast cancer survivors, aimed at reducing stress, anxiety, and depressive symptoms, and enhancing coping strategies and empowerment. Participants will be encouraged to engage with the app modules during the study period and will complete baseline and post-intervention assessments, including validated psychological and usability measures.
- interventionNames
- Device: SerenApp Digital Psychological Intervention
- type
- NO_INTERVENTION
- label
- Usual Oncological Follow-up
- description
- Participants in this group will continue to receive standard oncological follow-up care according to routine clinical practice, without access to SerenApp during the study period. They will complete the same baseline and post-intervention assessments as the intervention group, which will allow comparison of psychological, quality of life, and healthcare resource outcomes.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. \-
References
Publications (0)
Data not yet available