Effects of a Group Versus Individual Cognitive Training Program on Chemotherapy-induced Cognitive Impairment (Chemobrain) in Breast Cancer Patients Undergoing Active Treatment

Обзор

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.

Вмешательства

• Поведенческое Health Education Program
  An informative leaflet will promote a healthy lifestyle with WHO guidelines to reduce cognitive decline, recommending a balanced diet, physical activity, social engagement, cognitive games, good sleep, stress management, hydration, and avoiding smoking and excessive alcohol.
• Поведенческое Individual Cognitive Training Program
  The cognitive training program (CT) on everyday cognition (EC) will be individualized, with each participant receiving a tailored dossier. The intervention includes four 1-month training periods (P1-P4), each featuring 20 activities, conducted at a rate of 5 activities per week over 4 months.
• Поведенческое Group training program
  The group cognitive training program (CT) on everyday cognition (EC) will be individualized, with each participant receiving a tailored dossier. The intervention includes four 1-month training periods (P1-P4), each featuring 20 activities, conducted at a rate of 5 activities per week over 4 months.

Первичные конечные точки

• Cognitive Function [Срок оценки: Baseline; "4 months final"]
• Subjective Perception of Cognitive Impairment in Cancer Patients [Срок оценки: Baseline; "4 months final"]

Вторичные конечные точки (5)

• Everyday Cognition [Срок оценки: Baseline; "4 months final"]
• Anxiety [Срок оценки: Baseline; "4 months final"]
• Functionality [Срок оценки: Baseline; "4 months final"]
• Sleep Quality [Срок оценки: Baseline; "4 months final"]
• Subjective Memory Failures [Срок оценки: Baseline; "4 months final"]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 2 центра

• Juan Luis — Salamanca
• Juan Luis — Salamanca

Публикации

• Teixeira 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

Идентификаторы

NCT: NCT07165912 · ChemoSala

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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