Breast CancerSerenAppNCT07169539
Digital Tool for Psychological Support in Women With Breast Cancer
A study testing SerenApp Digital Psychological Intervention in people with Breast Cancer, run by Hospital Costa del Sol at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SerenApp Digital Psychological Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Hospital Universitario Costa del Sol
Marbella, Malaga, 29603
Esperanza Varela-Moreno, PhD, +34951978620, esperanza.varela@ibima.eu
Servicio Canario de la Salud
Santa Cruz de Tenerife, 38001
Lilisbeth Perestelo-Pérez, PhD, +34922478267, lilisbeth.peresteloperez@sescs.es
About this study
Official 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
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.
Read more
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?
Read the 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
- Being tested
- SerenApp Digital Psychological Intervention
- Keywords
- Breast cancer, Breast cancer survivors, Digital psychological intervention, eHealth, Mobile app, Co-creation, Effectiveness, Cost-effectiveness
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerenApp Digital Psychological InterventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline (T0) and 8 weeks (T1).
Secondary outcomes (3)
Change in Health-Related Quality of Life
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)
Measured: Baseline (T0) and 8 weeks (T1)
Usability of SerenApp
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)
Measured: 8 weeks (T1, post-intervention only).
Satisfaction with Care
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)
Measured: 8 weeks (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Costa del Sol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Zarcos-Pedrinaci, PhD, Principal investigator, Hospital Universitario Costa del Sol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169539
- Sponsor's protocol ID
- PI24/01193
- Acronym
- SerenApp
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset containing individual participant data underlying the primary and secondary outcome measures will be shared. Supporting documentation will include the study protocol and the statistical analysis plan. If feasible, analytic code will also be provided. No identifying information will be disclosed.
Publications
Zarcos-Pedrinaci I, Ramos-Garcia V, Padilla-Ruiz M, Rivas-Ruiz F, Baena A, Galan S, Duarte-Diaz A, Perestelo-Perez L, Alvarez Perez Y, Valcarcel-Nazco C, Redondo Bautista M, Varela-Moreno E. Cocreation of a Digital Psychological Intervention to Improve Mental Health Among Survivors of Breast Cancer (SerenApp): Protocol for a Usability and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Sep 30;15:e87151. doi: 10.2196/87151.
PubMed 42814999
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07169539
- Acronym / sponsor ID
- SerenApp / PI24/01193
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Breast cancer survivors, Digital psychological intervention, eHealth, Mobile app, Co-creation, Effectiveness, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Costa del SolUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SerenApp Intervention | Experimental | Device: SerenApp Digital Psychological InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerenApp Digital Psychological InterventionSerenApp 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. | Device | SerenApp Intervention |
Primary outcome
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.
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.
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
3 secondary outcomes
Change in Health-Related Quality of Life
Time frame: Baseline (T0) and 8 weeks (T1)
Usability of SerenApp
Time frame: 8 weeks (T1, post-intervention only).
Satisfaction with Care
Time frame: 8 weeks (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Derived from this study: PubMed 42814999Zarcos-Pedrinaci I, Ramos-Garcia V, Padilla-Ruiz M, Rivas-Ruiz F, Baena A, Galan S, Duarte-Diaz A, Perestelo-Perez L, Alvarez Perez Y, Valcarcel-Nazco C, Redondo Bautista M, Varela-Moreno E. Cocreation of a Digital Psychological Intervention to Improve Mental Health Among Survivors of Breast Cancer (SerenApp): Protocol for a Usability and Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Sep 30;15:e87151. doi: 10.2196/87151.
- Individual participant dataSharing planned: Yes. A de-identified dataset containing individual participant data underlying the primary and secondary outcome measures will be shared. Supporting documentation will include the study protocol and the statistical analysis plan. If feasible, analytic code will also be provided. No identifying information will be disclosed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irene Zarcos-Pedrinaci, PhD principal investigator
Hospital Universitario Costa del Sol
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SerenApp Digital Psychological Intervention in people with Breast Cancer, run by Hospital Costa del Sol at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esperanza Varela-Moreno, PhD (+34951986620, esperanza.varela@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress Coping Strategies (time frame: Baseline (T0) and 8 weeks (T1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.