Randomized Controlled Clinical Trial of Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy. The PsyCARTkids Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Symbol Digit Modalities Test (SDMT).
研究概览
简要总结
This randomized controlled clinical trial evaluates neurocognitive, biopsychological, and brain connectome outcomes in children and adolescents with acute lymphoblastic leukemia who have previously received Chimeric Antigen Receptor T-cell therapy (CAR T-cell therapy), chemotherapy, and/or hematopoietic stem cell transplantation (HSCT).
Participants will receive a multimodal, telematic psychological intervention combining digital cognitive training and an adapted mindfulness-based emotional regulation program. Outcomes will be compared with a waitlist control group and intervention sequences will be counterbalanced: (1) cognitive training followed by mindfulness; and (2) mindfulness followed by cognitive training.
Neurocognitive performance, emotional-behavioral functioning, executive functioning and EEG-based functional connectivity will be assessed at baseline, post-intervention and at 6 months follow-up.
详细描述
Children and adolescents treated for acute lymphoblastic leukemia are at increased risk of long-term neurocognitive, emotional, and psychosocial difficulties, particularly following intensive treatments such as CAR T-cell therapy, chemotherapy, and hematopoietic stem cell transplantation. Despite increasing survival rates, evidence-based psychological interventions targeting these sequelae remain limited.
This single-center randomized controlled clinical trial aims to evaluate the efficacy of a multimodal psychological intervention delivered remotely. The intervention combines digital cognitive training with a mindfulness-based stress reduction (MBSR) program adapted for pediatric populations.
Participants will be randomly assigned either to an immediate intervention group or to a waitlist control group. Within the intervention group, participants will be further allocated to one of two counterbalanced intervention sequences: (1) cognitive training followed by mindfulness or (2) mindfulness followed by cognitive training.
Assessments will include standardized neurocognitive tests administered in person, parent- and self-report questionnaires completed online via secure platforms, and electroencephalography (EEG) recordings to evaluate functional brain connectivity. Outcome measurements will be conducted at baseline, immediately following the intervention, and at a 6-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute B-cell lymphoblastic leukemia.
- •Previous treatment with CAR-T therapy, chemotherapy, and/or hematopoietic stem cell transplantation.
- •Age between 8 and 18 years.
- •Native Spanish speaker or high proficiency in Spanish sufficient to understand study procedures and complete assessment instruments.
- •Access to a computer, tablet, or smartphone with an Internet connection.
排除标准
- •Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
- •Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.
研究组 & 干预措施
Mindfulness → Cognitive Training
Participants receive a mindfulness-based intervention delivered online followed by digital cognitive training.
干预措施: Digital cognitive training (Behavioral)
Mindfulness → Cognitive Training
Participants receive a mindfulness-based intervention delivered online followed by digital cognitive training.
干预措施: Online Mindfulness-Based Intervention (Behavioral)
Waitlist Control
Participants do not receive the intervention during the main study period and are offered the full program after study completion.
Cognitive Training → Mindfulness
Participants receive digital cognitive training followed by a mindfulness-based intervention delivered online.
干预措施: Digital cognitive training (Behavioral)
Cognitive Training → Mindfulness
Participants receive digital cognitive training followed by a mindfulness-based intervention delivered online.
干预措施: Online Mindfulness-Based Intervention (Behavioral)
结局指标
主要结局
Symbol Digit Modalities Test (SDMT).
时间窗: Baseline
It assesses processing speed based on the total number of items completed in 90 seconds. Scores range from 0 to a maximum determined by the speed of task completion. Higher scores indicate better processing speed. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Symbol Digit Modalities Test (SDMT)
时间窗: 6 months
It assesses processing speed based on the total number of items completed in 90 seconds. Scores range from 0 to a maximum determined by the speed of task completion. Higher scores indicate better processing speed. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Continuous Performance Test, third edition (CPT-3)
时间窗: Baseline
It assesses sustained visual attention, impulsivity, and vigilance through continuous performance tasks that require responses to target stimuli and inhibition of non-target stimuli. Outcome measures include omission errors, commission errors, reaction time, and variability, which are expressed as standardized T-scores. Higher T-scores indicate poorer performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Clinical Assessment of Memory (ECM)
时间窗: Baseline
It assesses working memory and immediate memory in auditory-verbal and visuospatial modalities. Scores are expressed as standardized scores based on Spanish norms. Higher scores indicate better memory performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Verbal Fluency Test (VFT)
时间窗: Baseline
Assesses linguistic and executive functions, including phonological and semantic fluency. The score is the total number of correct words generated in 60 seconds. Higher scores indicate better performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Stroop. Test of Colors and Words. Revised edition.
时间窗: Baseline
It measures attention and executive functioning, specifically the ability to inhibit automatic responses and resist interference from established behavior patterns. Scores are based on the number of correct responses completed in 45 seconds, depending on the condition. Higher scores indicate better executive functioning. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Continuous Performance Test, third edition (CPT-3)
时间窗: 6 months
It assesses sustained visual attention, impulsivity, and vigilance through continuous performance tasks that require responses to target stimuli and inhibition of non-target stimuli. Outcome measures include omission errors, commission errors, reaction time, and variability, which are expressed as standardized T-scores. Higher T-scores indicate poorer performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Clinical Assessment of Memory (ECM)
时间窗: 6 months
It assesses working memory and immediate memory in auditory-verbal and visuospatial modalities. Scores are expressed as standardized scores based on Spanish norms. Higher scores indicate better memory performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Stroop. Test of Colors and Words. Revised edition
时间窗: 6 months
It measures attention and executive functioning, specifically the ability to inhibit automatic responses and resist interference from established behavior patterns. Scores are based on the number of correct responses completed in 45 seconds, depending on the condition. Higher scores indicate better executive functioning. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
Verbal Fluency Test (VFT)
时间窗: 6 months
Assesses linguistic and executive functions, including phonological and semantic fluency. The score is the total number of correct words generated in 60 seconds. Higher scores indicate better performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
次要结局
- Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)(Baseline)
- Behavior Assessment System for Children, third edition (BASC-3)(Baseline)
- Brief Pain Inventory (BPI)(Baseline)
- Adolescent Insomnia Questionnaire (AIQ)(Baseline)
- Pediatric Sleep Disturbances Short Form (PROMIS)(Baseline)
- Child and Adolescent Mindfulness Measure (CAMM).(Baseline)
- Brain Functional Connectivity(Baseline)
- Biomarkers(Baseline)
- Behavior Assessment System for Children, third edition (BASC-3)(3 months)
- Brief Pain Inventory (BPI)(3 months)
- Adolescent Insomnia Questionnaire (AIQ)(3 months)
- Pediatric Sleep Disturbances Short Form (PROMIS)(3 months)
- Child and Adolescent Mindfulness Measure (CAMM)(3 months)
- Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)(6 months)
- Behavior Assessment System for Children, third edition (BASC-3)(6 months)
- Brief Pain Inventory (BPI)(6 months)
- Adolescent Insomnia Questionnaire (AIQ)(6 months)
- Pediatric Sleep Disturbances Short Form (PROMIS)(6 months)
- Child and Adolescent Mindfulness Measure (CAMM)(6 months)
- Brain Functional Connectivity(6 months)
- Biomarkers(6 months)
研究者
Dr. Eduardo Fernández-Jiménez
Study Director
Hospital Universitario La Paz