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

November 26, 2024 updated by: Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fernandez PhD Eduardo
  • Phone Number: 699244390
  • Email: edujfr@usal.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function
Time Frame: Baseline; "4 months final";
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
Time Frame: Baseline; "4 months final";
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Everyday Cognition
Time Frame: Baseline; "4 months final";
Test for the Evaluation of Everyday Cognition (PECC)" (18): This test measures individuals' ability to solve 12 real-life situations grouped into the following areas: medication management, administrative management, financial management, meal preparation, transportation, and shopping. It helps assess functional capacity in daily life. The administration time is 35 minutes.
Baseline; "4 months final";
Anxiety
Time Frame: Baseline; "4 months final";
Hamilton Anxiety Rating Scale" (19): A clinical assessment tool used to evaluate the level of anxiety experienced by a person. It consists of 14 items, each with five response options ranging from "not present" to "very severe," with a score assigned to each response. A total score of 17 or less indicates mild anxiety; 18 to 24 indicates moderate anxiety; and 25 to 30 indicates severe anxiety.
Baseline; "4 months final";
Functionality
Time Frame: Baseline; "4 months final";
Lawton and Brody Instrumental Activities of Daily Living Scale" (20): Designed to assess autonomy in instrumental activities in the elderly population. The administration time is 4 minutes, and each item is scored as 0 or 1, with a total score of 8.
Baseline; "4 months final";
Sleep Quality
Time Frame: Baseline; "4 months final";
Pittsburgh Sleep Quality Index (PSQI)" (21): Developed to measure sleep quality in individuals aged 24 to 83 years. The administration time is 5-10 minutes. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Baseline; "4 months final";
Subjective Memory Failures
Time Frame: Baseline; "4 months final";
Everyday Memory Failures Questionnaire" (23): This questionnaire includes categories of forgetfulness such as "speaking, reading, and writing," "names and faces," "actions," and "learning new things." Responses are given on a Likert scale with nine response options for each question, ranging from "Never in the past 3 months" to "More than once a day." However, due to the difficulty of the nine options, other authors have used fewer response choices.
Baseline; "4 months final";

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEMOBRAIN COLON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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