Clinical trial NCT06710639: 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
Official title: Effects of a Cognitive Training Program on Chemotherapy-induced Cognitive Impairment (Chemobrain) in Oncology Patients With Colon Cancer Undergoing Active Treatment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oncology
Cancer-related Cognitive Impairment
Cognitive Training
Everyday Cognition
Clinical Trials
Colon Cancer
Keywords: Oncology
Cancer-related cognitive impairment
Cognitive training
Everyday cognition
Clinical trials
Colon cancer
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive Function
timeFrame: Baseline; "4 months final";
measure: Subjective Perception of Cognitive Impairment in Oncology Patients
timeFrame: Baseline; "4 months final";
Secondary outcomes:
measure: Everyday Cognition
timeFrame: Baseline; "4 months final";
measure: Anxiety
timeFrame: Baseline; "4 months final";
measure: Functionality
timeFrame: Baseline; "4 months final";
measure: Sleep Quality
timeFrame: Baseline; "4 months final";
measure: Subjective Memory Failures
timeFrame: Baseline; "4 months final";
Other outcomes:
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