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Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy

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About this study

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.

Condition
Acute Lymphoblastic Leukemia
Tested
Digital cognitive training, Online Mindfulness-Based Intervention
Sponsor
Hospital Universitario La Paz

Who can join

Age
8 to 18 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 8 years
  • Maximum age: 18 years
  • Study condition: Acute Lymphoblastic Leukemia
  • 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 2

  • Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
  • Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.

Where

1 site, 1 recruiting

Hospital Universitario La Paz

Madrid, Madrid, Spain

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.