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

NCT07479927 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-18

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Digital cognitive training

Adaptive exercises targeting attention, processing speed, memory and executive functions. Twelve-week intervention via Sincrolab online platform (4 practices per week, 15 minutes each), with a weekly online group session to encourage adherence.

BEHAVIORAL

Online Mindfulness-Based Intervention

Adapted Mindfulness-Based Stress Reduction (MBSR) program for children and adolescents. Twelve weekly online group sessions with guided home practice (4 practices, 15 minutes each) using audio materials.

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    collaborator OTHER

  • Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2027-07-30
Completion
2027-12-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07479927 on ClinicalTrials.gov