Trials / Not Yet Recruiting
Not Yet RecruitingNCT06710639
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
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- University of Salamanca · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Oncology
- Cancer-related Cognitive Impairment
- Cognitive Training
- Everyday Cognition
- Clinical Trials
- Colon Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2025-12-31
- Completion
- 2026-01-31
- First posted
- 2024-11-29
- Last updated
- 2024-11-29
Source: ClinicalTrials.gov record NCT06710639. Inclusion in this directory is not an endorsement.