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

Summary

Introduction: Given the increase in breast cancer survival rates, resulting from technological and biomedical advancements, it is essential to conduct an exhaustive study of the secondary symptoms associated with the oncological disease process. One of the most common and often underestimated symptoms is cancer-related cognitive impairment (CRCI).

Objective: To assess the effectiveness of a cognitive training program in managing CRCI in individuals with breast cancer undergoing active treatment.

Methodology: This is a randomized controlled clinical trial with two parallel groups: an Intervention Group (IG) and a Control Group (CG). The study population will consist of individuals with a new diagnosis of breast cancer. A required sample size of 50 participants has been estimated, with 25 in each group, to detect a difference equal to or greater than 2.95 points on the MoCA (Montreal Cognitive Assessment) questionnaire for cognitive impairment. All participants will receive an educational leaflet based on the new WHO guidelines, which recommend specific measures to reduce the risk of cognitive decline. In addition to this informative leaflet, the IG will receive a personalized cognitive training program (CT) focused on everyday cognition (EC). Each participant will be provided with a dossier containing 80 intervention sessions. The program will be divided into four training periods (P1-P4), each consisting of 20 activities, and each period will be conducted over one month. A baseline evaluation and a follow-up at 4 months post-intervention will be conducted for both groups. The assessments will measure sociodemographic and clinical variables, as well as study-related change variables related to cognitive impairment: Cognitive function (MoCA test), Everyday Cognition (PECC), Anxiety (Hamilton), Functionality (LB), Sleep quality (PSQI), Quality of life (ECOG), and Subjective memory complaints (FACT-COG).

Impact: The results of this study could lead to the design of specific cognitive interventions and the establishment of protocols for breast cancer patients undergoing active treatment. These interventions may help manage one of the most underestimated symptoms in this patient population, CRCI, whose incidence is increasing due to the higher survival rates in this disease.

Conditions

• Cancer-related Cognitive Impairment
• Oncology
• Breast Cancer
• Cognitive Training
• Everyday Cognition
• Clinical Trials

Interventions

BEHAVIORAL

Health Education Program

n 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.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Salamanca

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2025-10-01

Completion

2025-10-01

Countries

• Spain

Study Locations