Clinical trial · Interventional
Effects of a Group Versus Individual Cognitive Training Program on Chemotherapy-induced Cognitive Impairment (Chemobrain) in Breast Cancer Patients Undergoing Active Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Introduction: The significant improvement in breast cancer survival, largely attributable to biomedical and technological progress, makes it increasingly necessary to investigate the secondary effects linked to this pathology. Among these, cancer-related cognitive impairment (CRCI) stands out as one of the most frequent yet frequently overlooked complications. Objective: To evaluate the impact of a structured cognitive training program on the management of CRCI in patients with breast cancer receiving active treatment. Methodology: A randomized controlled clinical trial will be conducted with two arms: an Intervention Group (IG) and a Control Group (CG). The study will include patients with a recent diagnosis of breast cancer. Based on sample size calculations, 50 participants will be recruited-25 per group-to detect a minimum difference of 2.95 points on the MoCA (Montreal Cognitive Assessment), a tool commonly used to assess cognitive performance. All participants will receive an informational leaflet aligned with the latest WHO recommendations for preventing cognitive decline. In addition, the IG will complete an individualized cognitive training (CT) program focused on everyday cognitive skills (EC). The program will provide a dossier with 80 training sessions, structured into four phases (P1-P4) of 20 activities each, to be implemented monthly. Baseline assessments and a follow-up four months after the intervention will be carried out in both groups. Variables collected will include sociodemographic and clinical data, as well as outcome measures for cognitive status (MoCA), everyday cognition (PECC), anxiety levels (Hamilton scale), functional capacity (LB), sleep quality (PSQI), quality of life (ECOG), and subjective memory complaints (FACT-COG). Impact: Findings from this study could support the development of targeted cognitive rehabilitation strategies and the implementation of clinical protocols for individuals undergoing breast cancer treatment. By addressing CRCI-an underrecognized but increasingly prevalent issue given rising survival rates-these interventions may contribute to improving patients' overall quality of life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Females | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group training program | Behavioral | — | UNRESOLVED |
| Health Education Program | Behavioral | — | UNRESOLVED |
| Individual Cognitive Training Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group intervention
- description
- The program is organized into four progressive months: (1) cognitive and emotional security, with activities focused on attention, basic memory, and group bonding; (2) flexibility and problem solving, where executive functions, language, and personal narrative are stimulated; (3) cognitive challenges and emotional control, which strengthen spatial memory, self-concept, and relaxation techniques; and (4) closure and consolidation of learning, dedicated to reinforcing achievements, promoting gratitude, and strengthening mutual support. In this way, ALMA not only seeks to train the mind, but also to provide a space for comprehensive support for the emotional and physical well-being of the participants.
- interventionNames
- Behavioral: Health Education Program
- type
- EXPERIMENTAL
- label
- Individual intervention group
- description
- The indiviudal cognitive training program (CT) focused on everyday cognition (EC) will be conducted individually. Each participant will receive a dossier specifically designed for the study. The intervention will consist of four training periods over a duration of 4 months (Period 1, P1; Period 2, P2; Period 3, P3; Period 4, P4), with 20 activities each. Each period will last one month (5 activities per week).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Being an adult (18 years or older). Having a recent histopathological diagnosis of newly diagnosed breast cancer and starting oncological treatment. Being fully capable of performing daily functions. Willingness to voluntarily participate in the study and signing the informed consent. Exclusion Criteria: Lack of literacy skills or significant language comprehension deficit. Diagnosis of a Central Nervous System tumor or participation in another cognitive stimulation program. Clinical diagnosis of a neurocognitive disorder as defined in the DSM-V. Withdrawal Criteria: Dropping out of the program or not completing the final evaluation
References
Publications (1)
- DERIVEDTeixeira de Sousa SR, Sanchez-Rodriguez JL, Sanchez-Gil A, Sanchez-Gomez C, Arroyo-Garrapucho N, Fonseca-Sanchez E, Figuero-Perez L, Sanchez-Gonzalez JL, Fernandez-Rodriguez EJ. Effectiveness of the ALMA Intervention on Cognitive Function in Women with Breast Cancer: Protocol for a Randomized Controlled Trial. J Clin Med. 2026 Jun 23;15(13):4876. doi: 10.3390/jcm15134876. PMID 42452339