JMIR Publications

ABSTRACT

Background:

Breast cancer survivors frequently experience persistent psychological symptoms such as anxiety, stress, and depression, particularly during the follow-up and survivorship phases. Although psychological interventions have proven effective, their implementation in routine clinical practice remains limited. Digital mental health interventions offer a promising alternative but often lack personalization and adherence, partly due to limited patient involvement in their design.

Objective:

The aim of the SerenApp project is to develop and pilot-test a co-created digital psychological intervention designed to improve the well-being of women during oncological follow-up and breast cancer survivorship, integrating the perspectives of both patients and healthcare professionals.

Methods:

This mixed-methods study follows a participatory co-creation design structured in three phases. Phase 1 will identify unmet psychological needs and co-design the app’s content and functionalities through workshops with breast cancer survivors and healthcare professionals, applying Design Thinking and the Co-Cre-Ar-E model. Phase 2 will focus on the technical development of the digital solution using an agile Scrum methodology, followed by usability and technical validation (Alpha Testing). Phase 3 will consist of a pilot randomized controlled trial (n=90; 45 intervention, 45 control) conducted in Málaga and the Canary Islands. The pilot will evaluate acceptability, usability, adherence, psychological impact, and cost-effectiveness of SerenApp compared with usual care. Validated instruments include the CAEPO, PHQ-9, HADS, EQ-5D-5L, SUS, CSQ-8, CSRI, and MARS. Quantitative analyses (ANOVA, multilevel regression, ICER/ICUR) and qualitative analyses (thematic analysis using NVivo) will be performed.

Results:

At the time of manuscript submission, the co-creation phase (Phase 1) had been completed, and the development of the digital tool (Phase 2) was in progress. Results from the pilot study (Phase 3) are expected to provide evidence regarding the intervention’s feasibility, usability, preliminary effectiveness, and cost-effectiveness. Findings will be used to optimize the digital tool before conducting a large-scale randomized controlled trial.

Conclusions:

This protocol outlines the development and pilot evaluation of SerenApp, a co-created digital intervention to promote psychological well-being in women with breast cancer. The co-creation approach is expected to improve usability, adherence, and clinical impact, addressing key barriers that have limited the success of previous digital interventions. The project represents an important step toward integrating user-centered digital mental health solutions into routine oncology care. Clinical Trial: ClinicalTrials.gov Identifier: NCT07169539