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

Sponsor
Hospital Universitario La Paz
Study ID
NCT07479927
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Digital cognitive training — BEHAVIORAL
    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.
  • Online Mindfulness-Based Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Mar 18, 2026
Start date
Dec 19, 2025
Status verified
Mar 2026
Primary completion
Jul 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Training → Mindfulness
    Participants receive digital cognitive training followed by a mindfulness-based intervention delivered online.
  • Experimental: Mindfulness → Cognitive Training
    Participants receive a mindfulness-based intervention delivered online followed by digital cognitive training.
  • No Intervention: Waitlist Control
    Participants do not receive the intervention during the main study period and are offered the full program after study completion.

Primary Outcome Measure

Symbol Digit Modalities Test (SDMT). [ Time Frame: Baseline ]

Central Contacts

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