Overview
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.
Description
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.
Eligibility
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.
