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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06686823
• Lead Sponsor: University of Salamanca

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Study Start: 2024-12-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive Function	Baseline; "4 months final";	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	Baseline; "4 months final";	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.

Secondary Outcome Measures

Name	Time	Method
Everyday Cognition	Baseline; "4 months final";	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	Baseline; "4 months final";	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	Baseline; "4 months final";	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	Baseline; "4 months final";	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.
Subjective Memory Failures	Baseline; "4 months final";	Everyday Memory Failures Questionnaire (23): It includes categories such as "talking, reading, and writing," "names and faces," "actions," and "learning new things." Responses are given on a 9-point Likert scale, ranging from "Not at all in the last 3 months" to "More than once a day." Due to the complexity of the nine options, some authors use fewer response options.