RecruitingNot Applicable

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

Spain40 participantsStarted 2025-12-19

Plain-language 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.

Who can participate

Age range

8 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Symbol Digit Modalities Test (SDMT).

Timeframe: Baseline

Continuous Performance Test, third edition (CPT-3)

Timeframe: Baseline

Clinical Assessment of Memory (ECM)

Timeframe: Baseline

Verbal Fluency Test (VFT)

Timeframe: Baseline

Stroop. Test of Colors and Words. Revised edition.

Timeframe: Baseline

Symbol Digit Modalities Test (SDMT)

Timeframe: 6 months

Continuous Performance Test, third edition (CPT-3)

Timeframe: 6 months

Clinical Assessment of Memory (ECM)

Timeframe: 6 months

Trial details

NCT IDNCT07479927

SponsorHospital Universitario La Paz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-30

Contact for this trial

Eduardo Fernandez Jimenes, Phd

+34917277417 eduferjim.psyc@gmail.com

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials

Plain-language summary

Who can participate

Age range

8 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Symbol Digit Modalities Test (SDMT).

Timeframe: Baseline

Continuous Performance Test, third edition (CPT-3)

Timeframe: Baseline

Clinical Assessment of Memory (ECM)

Timeframe: Baseline

Verbal Fluency Test (VFT)

Timeframe: Baseline

Stroop. Test of Colors and Words. Revised edition.

Timeframe: Baseline

Symbol Digit Modalities Test (SDMT)

Timeframe: 6 months

Continuous Performance Test, third edition (CPT-3)

Timeframe: 6 months

Clinical Assessment of Memory (ECM)

Timeframe: 6 months