肿瘤细胞治疗研究
英文原题：Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
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这是一项分期未标注的注册临床试验，评估细胞治疗用于急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 40 例。试验地点：欧洲 · 马德里（共 1 个中心）。登记号：NCT07479927。
不限性别 · ≥ 8 Years 且 ≤ 18 Years
纳入标准：确诊B细胞急性淋巴细胞白血病；既往接受CAR-T 治疗、化疗和/或造血干细胞移植；年龄8–18岁；西班牙语为母语或熟练掌握西班牙语，足以理解研究流程并完成评估工具；可使用联网电脑、平板或智能手机。 排除标准：确诊智力障碍、自闭症谱系障碍或获得性脑损伤；存在与白血病无关且未控制或不稳定的躯体或精神疾病。
Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury. * Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Symbol Digit Modalities Test (SDMT). · 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. · Baseline；Continuous Performance Test, third edition (CPT-3) · 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. · Baseline；Clinical Assessment of Memory (ECM) · 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. · Baseline；Verbal Fluency Test (VFT) · 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. · Baseline；Stroop. Test of Colors and Words. Revised edition. · 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. · Baseline；Symbol Digit Modalities Test (SDMT) · 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. · 6 months
次要终点：Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)；Behavior Assessment System for Children, third edition (BASC-3)；Brief Pain Inventory (BPI)；Adolescent Insomnia Questionnaire (AIQ)；Pediatric Sleep Disturbances Short Form (PROMIS)；Child and Adolescent Mindfulness Measure (CAMM).；Brain Functional Connectivity；Biomarkers
参与者先接受数字认知训练，随后在线接受正念干预。
参与者先在线接受正念干预，随后接受数字认知训练。
主要研究期间参与者不接受干预；研究结束后可获得完整项目。
以上邮箱 / 电话是登记库里的申办方联系方式，通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
这项随机对照临床试验评估既往接受CAR-T 细胞治疗、化疗和/或造血干细胞移植（HSCT）的急性淋巴细胞白血病儿童和青少年的神经认知、生物心理学及脑连接组结局。参与者接受多模式远程心理干预，结合数字认知训练和经调整的正念情绪调节项目；研究将其与候补名单对照组比较，干预顺序采用平衡设计：认知训练后接正念，或正念后接认知训练。在基线、干预后及6个月随访时评估神经认知表现、情绪行为、执行功能及基于脑电图的功能连接。
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.
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