At-home cognitive training and mindfulness for children after CAR-T, transplant, or chemotherapy
Randomized Controlled Clinical Trial of Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy. The PsyCARTkids Project
This program tests whether remote digital cognitive exercises combined with adapted mindfulness can help thinking, behavior, and brain function in children and teens treated for acute lymphoblastic leukemia after CAR‑T, chemotherapy, or transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, CAR T, Chimeric Antigen Receptor |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07479927 on ClinicalTrials.gov |
What this trial studies
This single-center randomized trial delivers a multimodal, telematic psychological intervention that pairs digital cognitive training with a pediatric-adapted mindfulness-based emotional regulation program. Participants are randomized to immediate intervention or a waitlist control, and those in the intervention arm receive the two components in counterbalanced order (cognitive training then mindfulness, or mindfulness then cognitive training). Outcomes include standardized neurocognitive tests, parent- and self-report measures of emotional and executive functioning, and EEG-based measures of functional brain connectivity measured at baseline, post-intervention, and 6-month follow-up. Most intervention sessions are remote, while cognitive testing and EEG recordings are performed in person at the recruiting center.
Who should consider this trial
Good fit: Children and adolescents aged 8–18 with B‑cell acute lymphoblastic leukemia who previously received CAR‑T therapy, chemotherapy, or hematopoietic stem cell transplant, who speak Spanish and have internet access are ideal candidates.
Not a fit: Patients with intellectual disability, autism spectrum disorder, acquired brain injury, or uncontrolled medical or psychiatric conditions unrelated to leukemia are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, participants may experience improved attention, memory, emotional regulation, and detectable improvements in brain connectivity that could translate to better daily functioning.
How similar studies have performed: Previous trials of cognitive training or mindfulness in pediatric cancer survivors have shown modest benefits, but the combined remote approach specifically in patients after CAR‑T or HSCT is relatively novel and less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madrid, Madrid
- Hospital Universitario La Paz — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Eduardo Fernandez Jimenes, Phd
- Email: eduferjim.psyc@gmail.com
- Phone: +34917277417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.