Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: 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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fernandez PhD Eduardo

CONTACT

[email protected]

699244390

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.