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

NCT07165912 | Not Yet Recruiting

• 1 other identifier: ChemoSala
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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

Breast Cancer Females; Oncology

Keywords

Cognitive training; Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline; "4 months final"

• 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.

  Baseline; "4 months final"

Secondary Outcomes (5)

• Everyday Cognition

  Baseline; "4 months final"

• Anxiety

  Baseline; "4 months final"

• Functionality

  Baseline; "4 months final"

• Sleep Quality

  Baseline; "4 months final"

• Subjective Memory Failures

  Baseline; "4 months final"

Study Arms (3)

Group intervention

EXPERIMENTAL

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.

Behavioral: Health Education Program

Individual intervention group

EXPERIMENTAL

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).

Behavioral: Group training program

Health Education Program

ACTIVE COMPARATOR

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.

Behavioral: Individual Cognitive Training Program

Interventions

Health Education Program BEHAVIORAL

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.

Group intervention

Individual Cognitive Training Program 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.

Health Education Program

Group training program BEHAVIORAL

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.

Individual intervention group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (2)

Juan Luis

Salamanca, Salamanca, 37004, Spain

Location

Juan Luis

Salamanca, Salamanca, 37004, Spain

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Juan Luis Sánchez González, Phd

CONTACT

+34660738949; juanluissanchez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Access Criteria: The data will be available upon request in the GREDOS scientific repository of the University of Salamanca once the study is completed. Link: https://gredos.usal.es/handle/10366/3823.

Locations

ES (2)