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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Cognitive Function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cognitive Function
时间窗: 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.
Subjective Perception of Cognitive Impairment in Oncology Patients
时间窗: 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.
次要结局
- 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";)
研究者
Prof. Dr. Eduardo J Fernández Rodríguez
Professor
University of Salamanca