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

NCT06710639 | Not Yet Recruiting DMC

• 1 other identifier: CHEMOBRAIN COLON
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Cognitive Function

  The Montreal Cognitive Assessment Test (MoCA test) Version 8.3" (17): This test allows the detection of mild cognitive impairment (MCI) by evaluating executive functions, attention, abstraction, memory, calculation, and orientation. The administration time is 10 minutes. The maximum score is 30 points, with scores below 26 indicating MCI.

  Baseline; "4 months final";

• Subjective Perception of Cognitive Impairment in Oncology Patients

  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, the tool includes two other subscales: "notability" (comments from others) and "impact of perceived cognitive impairment on quality of life." Respondents indicate the frequency of each occurrence during the 7 days prior to the test on a 5-point Likert scale ranging from 0, "never," to 4, "several times a day." The individual subscale scores are summed to determine the total FACT-Cog score, which ranges from 0 to 148, with higher scores indicating better cognitive functioning.

  Baseline; "4 months final";

Secondary Outcomes (5)

• Everyday Cognition

  Baseline; "4 months final";

• Anxiety

  Baseline; "4 months final";

• Functionality

  Baseline; "4 months final";

• Sleep Quality

  Baseline; "4 months final";

• Subjective Memory Failures

  Baseline; "4 months final";

Study Arms (2)

Health Education Program

ACTIVE COMPARATOR

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.

Behavioral: Health Education Program

Cognitive Training Program

EXPERIMENTAL

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).

Behavioral: Cognitive Training Program

Interventions

Health Education Program BEHAVIORAL

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.

Health Education Program

Cognitive Training Program BEHAVIORAL

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.

Cognitive Training Program

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Fernandez PhD Eduardo

CONTACT

699244390; edujfr@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 29, 2024
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Access Criteria: The data will be available upon request in the GREDOS scientific repository of the University of Salamanca once the study is completed. Link: https://gredos.usal.es/handle/10366/3823.