Digital Tool for Psychological Support in Women With Breast Cancer

NCT07169539 | Not Yet Recruiting

• 1 other identifier: PI24/01193
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer

Keywords

Breast cancer; Breast cancer survivors; Digital psychological intervention; eHealth; Mobile app; Co-creation; Effectiveness; Cost-effectiveness

Outcome Measures

Primary Outcomes (3)

• Change in Stress Coping Strategies

  The CAEPO assesses cognitive and behavioral coping strategies used by oncology patients to manage stress related to their disease. It includes 40 items across seven subscales: Confrontation and Active Fighting, Self-Control and Emotional Control, Seeking Social Support, Anxiety and Anxious Worry, Passivity and Passive Resignation, Escape and Distancing, and Denial. Each item is rated on a 4-point Likert scale (0-3), with higher scores indicating greater use of each coping strategy.

  Baseline (T0) and 8 weeks (T1)

• Change in Anxiety Symptoms

  Measured using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A), this outcome evaluates changes in anxiety symptom severity in breast cancer survivors. The HADS-A consists of 7 items rated on a 0-3 Likert scale, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptoms.

  Baseline (T0, before intervention) and 8 weeks post-intervention (T1)

• Change in Depressive Symptoms

  Depressive symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item scale widely used in oncology and primary care. Higher scores indicate more severe depression. Total Score: 0-27

  Baseline (T0) and 8 weeks (T1).

Secondary Outcomes (3)

• Change in Health-Related Quality of Life

  Baseline (T0) and 8 weeks (T1)

• Usability of SerenApp

  8 weeks (T1, post-intervention only).

• Satisfaction with Care

  8 weeks (T1)

Other Outcomes (3)

• Healthcare Resource Use and Cost-effectiveness

  Baseline (T0) and 8 weeks (T1)

• Adherence to the Intervention

  Continuously during the 8-week intervention period

• Qualitative Experiences, Barriers, and Facilitators

  After 8 weeks (T1)

Study Arms (2)

SerenApp Intervention

EXPERIMENTAL

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.

Device: SerenApp Digital Psychological Intervention

Usual Oncological Follow-up

NO INTERVENTION

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.

Interventions

SerenApp Digital Psychological Intervention DEVICE

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.

SerenApp Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Costa del Sol: lead

Study Sites (2)

Hospital Universitario Costa del Sol

Marbella, Malaga, 29603, Spain

Location

Servicio Canario de la Salud

Santa Cruz de Tenerife, 38001, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Irene Zarcos-Pedrinaci, PhD

  Hospital Universitario Costa del Sol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esperanza Varela-Moreno, PhD

CONTACT

+34951986620; esperanza.varela@ibima.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot randomized controlled trial will assign participants in parallel to either the intervention group (access to SerenApp for 8 weeks) or the control group (usual oncological follow-up). The design allows comparison of psychological, usability, and health outcomes between groups to assess feasibility and potential effectiveness of the digital intervention.

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available 12 months after publication of primary results, for a minimum of 5 years
• Access Criteria: Researchers may request access by submitting a methodologically sound proposal to the study team. Approval will be required prior to data release

Locations

ES (2)