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

NCT ID: NCT06686823

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-01

Brief 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.

Detailed Description

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).

Ethical Considerations: The study will be conducted after obtaining approval from the Clinical Research Ethics Committee of the Salamanca Health Area. Informed consent will be obtained from all study participants, and data protection will be ensured.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Health Education Program

Instructions and recommendations will be provided in an informative leaflet to promote an active and healthy lifestyle, encouraging self-care and good practices. This leaflet will include the new WHO guidelines, which recommend specific measures to reduce the risk of cognitive decline. These measures are: Eating healthy foods, engaging in physical activity, maintaining social connections, playing challenging cognitive games, getting good sleep, managing stress, staying hydrated, and avoiding smoking and excessive alcohol consumption.

Group Type: ACTIVE_COMPARATOR

Health Education Program

Intervention Type: BEHAVIORAL

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.

Cognitive Training Program

The 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).

Group Type: EXPERIMENTAL

Cognitive Training Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Eduardo J Fernández Rodríguez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fernandez PhD Eduardo, Professor

Role: CONTACT

edujfr@usal.es

699244390

Other Identifiers

CHEMOBRAIN MAMA

Identifier Type: -

Identifier Source: org_study_id