Effects of Cognitive Training on Chemotherapy-Induced Cognitive Impairment in Colon Cancer Patients Undergoing Treatment(Chemobrain) in Oncology Patients With Colon Cancer Undergoing Active Treatment

University of Salamanca

Status: Not yet enrolling

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

Treatments: Behavioral: Health Education Program; Behavioral: Cognitive Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06710639

CHEMOBRAIN COLON

Details and patient eligibility

About

Introduction: With the increasing survival rate in colon cancer, as a result of technological and biomedical advancements, it is essential to thoroughly study the secondary symptoms related to the oncological disease process. One of the most common and underestimated symptoms is cancer-related cognitive impairment (CRCI).

Objective: To evaluate the efficacy of a cognitive training program in controlling CRCI in individuals with colon cancer undergoing active treatment.

Methodology: A randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will include individuals newly diagnosed with colon cancer. A sample size of 50 participants has been estimated, with 25 in each group, to detect a difference of 2.95 points or more in the MoCA cognitive impairment questionnaire. All participants will receive an educational leaflet based on the new WHO guidelines, which recommend specific measures to reduce the risk of cognitive impairment. In addition to receiving this informational leaflet, the IG will participate in a cognitive training program (CT) focused on everyday cognition (EC) individually. Each participant will receive a dossier with 80 intervention sessions divided into four training periods (P1-P4), each containing 20 activities. Each period will last for one month. Baseline and 4-month post-intervention evaluations will be conducted for both groups, measuring sociodemographic and clinical variables, as well as study-related cognitive impairment variables: 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 colon cancer patients undergoing active treatment, helping them manage one of the most underestimated symptoms in this patient population-CRCI-whose incidence is increasing due to the improved survival rates in this disease.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Being an adult (18 years or older). Having a recent pathological diagnosis of newly diagnosed colon 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 deficits. Having a diagnosis of a Central Nervous System tumor or participating in another cognitive stimulation program.

Having a 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Health Education Program

Active Comparator group

Description:

Instructions and recommendations will be provided in an informational leaflet to encourage an active and healthy lifestyle, promoting self-care and good health practices. This leaflet will include the new WHO guidelines recommending specific measures to reduce the risk of cognitive impairment. These measures are: eating healthy foods, engaging in physical activity, maintaining social contact, doing challenging cognitive games, getting good sleep, managing stress, staying hydrated, and avoiding smoking and excessive alcohol consumption.

Treatment:

Behavioral: Health Education Program

Cognitive Training Program

Experimental group

Description:

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 4 months (Period 1, P1; Period 2, P2; Period 3, P3; Period 4, P4), with 20 activities in each period. Each period will last one month (with 5 activities per week). To ensure compliance and therapeutic adherence, two types of follow-up will be carried out: in-person or via telematic (video call).

Treatment:

Behavioral: Cognitive Training Program