Effectiveness of the ALMA Intervention on Cognitive Function in Women with Breast Cancer: Protocol for a Randomized Controlled Trial

Background: Cancer-related cognitive impairment is a frequent and clinically relevant concern among women with breast cancer, particularly during active oncological treatment, with potential consequences for memory, attention, executive functioning, daily autonomy, emotional well-being, and quality of life. This study aims to evaluate the effectiveness of the Playful Attention and Active Memory intervention (ALMA) on cognitive functioning in women with breast cancer undergoing active oncological treatment. Methods: This single-centre, three-arm, parallel-group randomized controlled trial at the University Healthcare Complex of Salamanca (Spain) will evaluate 63 women with breast cancer undergoing active oncological treatment. Participants will be randomized (1:1:1) into a health education control group, an individual non-tailored cognitive training group, or the ALMA multidimensional group intervention (two 120 min face-to-face sessions/week for four months, combining psychoeducation, targeted cognitive stimulation, and group feedback). Assessments will occur at baseline and post-intervention. The primary outcome is objective global cognitive performance (Montreal Cognitive Assessment). Secondary outcomes include perceived cognitive function, everyday cognition, functional autonomy, anxiety, sleep quality, performance status, and everyday memory failures. Intention-to-treat analysis using linear mixed models will perform prespecified comparisons of ALMA versus both other groups. Expected results: This study is designed to provide evidence on the potential value of a structured, multidimensional cognitive intervention delivered during active breast cancer treatment. By comparing ALMA with both health education and individual cognitive training, the trial may clarify whether the integration of psychoeducation, ecological cognitive stimulation, and group-based support offers additional benefits beyond cognitive practice alone. The inclusion of objective, subjective, and functionally oriented outcomes strengthens the clinical relevance of the protocol and may contribute to the development of more comprehensive supportive care strategies for cancer-related cognitive impairment. Trial registration: This protocol is registered at ClinicalTrials.gov under the identifier NCT07165912.