Actively Recruiting
Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
Led by Hospital Universitario La Paz · Updated on 2026-03-18
40
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario La Paz
Lead Sponsor
I
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury
- Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
E
Eduardo Fernandez Jimenes, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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