Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07169539

Digital Tool for Psychological Support in Women With Breast Cancer

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?

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Costa del Sol, Marbella, Malaga, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

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.

Primary outcomes

  1. Change in Stress Coping Strategies

    Time frame: Baseline (T0) and 8 weeks (T1)

    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.

  2. Change in Anxiety Symptoms

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

    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.

  3. Change in Depressive Symptoms

    Time frame: Baseline (T0) and 8 weeks (T1).

    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

Secondary outcomes

  1. Change in Health-Related Quality of Life

    Time frame: Baseline (T0) and 8 weeks (T1)

    Measured with the EQ-5D-5L, a standardized instrument for assessing health status across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression Scale: Each of 5 dimensions rated from 1 (no problems) to 5 (extreme problems) Interpretation: Higher scores indicate better health-related quality of life (better outcome)

  2. Usability of SerenApp

    Time frame: 8 weeks (T1, post-intervention only).

    Measured with the System Usability Scale (SUS), a validated 10-item scale assessing usability and acceptability of digital interventions. Scale: 0-100 Interpretation: Higher scores indicate better usability and acceptability (better outcome)

  3. Satisfaction with Care

    Time frame: 8 weeks (T1)

    Measured with the Client Satisfaction Questionnaire-8 (CSQ-8), a validated tool assessing satisfaction with the intervention and overall care.

    Scale: 1-4 per item across 8 items Total Score: 8-32 Interpretation: Higher scores indicate greater satisfaction with care and the intervention (better outcome)

Other outcomes

  1. Healthcare Resource Use and Cost-effectiveness

    Time frame: Baseline (T0) and 8 weeks (T1)

    Resource use will be collected with the Client Service Receipt Inventory (CSRI), complemented with economic evaluation measures, to estimate cost-effectiveness of SerenApp compared to usual follow-up.

    Scale: Not standardized; costs reported in monetary units Interpretation: Lower costs with equivalent or improved outcomes indicate better cost-effectiveness

  2. Adherence to the Intervention

    Time frame: Continuously during the 8-week intervention period

    Measured with the Mobile Application Rating Scale (MARS) and app usage metrics (logins, time spent, module completion rates).

    MARS Scale: Typically 1-5 per item Usage Metrics: Number of logins, time spent, module completion rates Interpretation: Higher scores and greater engagement indicate better adherence (better outcome)

  3. Qualitative Experiences, Barriers, and Facilitators

    Time frame: After 8 weeks (T1)

    Explored through post-intervention focus groups with participants and healthcare professionals, analyzed using qualitative methods to identify barriers, facilitators, and perceived benefits.

    Scale: Not applicable (qualitative analysis) Interpretation: Themes are identified through focus group discussions; no numerical scoring

Study contacts

Contact information is provided by the study sponsor or research team.

Esperanza Varela-Moreno, PhD

CONTACT

[email protected]

+34951986620

Sponsors and collaborators

Lead sponsor

Hospital Costa del Sol

Other

Registry information

Official study 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

Acronym: SerenApp

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.