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.
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Health Education Program
BehavioralAn 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.
Individual Cognitive Training Program
BehavioralThe 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.
Group training program
BehavioralThe 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.
Cognitive Function
The Montreal Cognitive Assessment Test (MoCA Test) Version 8.3. This test detects mild cognitive impairment (MCI) by assessing executive functions, attention, abstraction, memory, calculation, and orientation. It takes about 10 minutes to administer. The maximum score is 30 points, with scores below 26 indicating MCI
Subjective Perception of Cognitive Impairment in Cancer Patients
FACT-COG (Version 3) (24): This 37-item questionnaire is divided into six cognitive domains: memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. Additionally, it includes two subscales: "notability" (comments from others) and "perceived impact of cognitive impairment on quality of life." Respondents indicate the frequency of each occurrence over the past 7 days on a 5-point Likert scale, from 0 ("never") to 4 ("several times a day"). The scores from the individual subscales are summed to determine the total FACT-Cog score, ranging from 0 to 148, with higher scores indicating better cognitive functioning.
Everyday Cognition
Test for the Evaluation of Everyday Cognition (PECC) (18): This test measures an individual's ability to solve 12 real-life situations in areas such as medication management, administrative tasks, financial management, meal preparation, transportation, and shopping, thus assessing functional capacity in daily life. The administration time is 35 minutes.
Anxiety
Hamilton Anxiety Rating Scale (19): A clinical assessment tool used to measure the level of anxiety experienced by a person. It consists of 14 items, each with five response options ranging from "not present" to "very severe." The final score can be 17 or less (mild anxiety), between 18 and 24 (moderate anxiety), and between 25 and 30 (severe anxiety).
Functionality
Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale (20): Designed to evaluate autonomy in instrumental activities in older adults. It takes about 4 minutes to administer, scoring each item as 0 or 1, with a total score of 8.
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) (21): Designed to measure sleep quality in individuals aged 24 to 83 years. It takes 5-10 minutes to administer. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
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