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
NCT ID: NCT06710639
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-03-01
2026-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Health Education Program
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.
Health Education Program
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.
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 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).
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.
Interventions
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Health Education Program
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.
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.
Eligibility Criteria
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Inclusion Criteria
Being fully capable of performing daily functions. Willingness to voluntarily participate in the study and signing the informed consent.
Exclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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University of Salamanca
OTHER
Responsible Party
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Prof. Dr. Eduardo J Fernández RodrÃguez
Professor
Central Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CHEMOBRAIN COLON
Identifier Type: -
Identifier Source: org_study_id