Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy (PsyCARTkids)
March 14, 2026 updated by: Dr. Eduardo Fernández-Jiménez, Hospital Universitario La Paz
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 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Children and adolescents treated for acute lymphoblastic leukemia are at increased risk of long-term neurocognitive, emotional, and psychosocial difficulties, particularly following intensive treatments such as CAR T-cell therapy, chemotherapy, and hematopoietic stem cell transplantation. Despite increasing survival rates, evidence-based psychological interventions targeting these sequelae remain limited.
This single-center randomized controlled clinical trial aims to evaluate the efficacy of a multimodal psychological intervention delivered remotely. The intervention combines digital cognitive training with a mindfulness-based stress reduction (MBSR) program adapted for pediatric populations.
Participants will be randomly assigned either to an immediate intervention group or to a waitlist control group. Within the intervention group, participants will be further allocated to one of two counterbalanced intervention sequences: (1) cognitive training followed by mindfulness or (2) mindfulness followed by cognitive training.
Assessments will include standardized neurocognitive tests administered in person, parent- and self-report questionnaires completed online via secure platforms, and electroencephalography (EEG) recordings to evaluate functional brain connectivity. Outcome measurements will be conducted at baseline, immediately following the intervention, and at a 6-month follow-up.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eduardo Fernandez Jimenes, Phd
- Phone Number: +34917277417
- Email: eduferjim.psyc@gmail.com
Study Locations
-
-
Madrid
-
Madrid, Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Contact:
- Eduardo Fernández-Jiménez, PhD
- Phone Number: +34917277417
- Email: eduferjim.psyc@gmail.com
-
Contact:
- Cristina Campoy Lacasa
- Phone Number: 2108965970
- Email: cristinacampoylacasa@gmail.com
-
Principal Investigator:
- Eduardo Fernández-Jiménez, PhD
-
Sub-Investigator:
- Cristina Campoy Lacasa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Training → Mindfulness
Participants receive digital cognitive training followed by a mindfulness-based intervention delivered online.
|
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.
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.
|
|
Experimental: Mindfulness → Cognitive Training
Participants receive a mindfulness-based intervention delivered online followed by 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.
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.
|
|
No Intervention: Waitlist Control
Participants do not receive the intervention during the main study period and are offered the full program after study completion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symbol Digit Modalities Test (SDMT).
Time Frame: Baseline
|
It assesses processing speed based on the total number of items completed in 90 seconds.
Scores range from 0 to a maximum determined by the speed of task completion.
Higher scores indicate better processing speed.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Continuous Performance Test, third edition (CPT-3)
Time Frame: Baseline
|
It assesses sustained visual attention, impulsivity, and vigilance through continuous performance tasks that require responses to target stimuli and inhibition of non-target stimuli.
Outcome measures include omission errors, commission errors, reaction time, and variability, which are expressed as standardized T-scores.
Higher T-scores indicate poorer performance.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Clinical Assessment of Memory (ECM)
Time Frame: Baseline
|
It assesses working memory and immediate memory in auditory-verbal and visuospatial modalities.
Scores are expressed as standardized scores based on Spanish norms.
Higher scores indicate better memory performance.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Verbal Fluency Test (VFT)
Time Frame: Baseline
|
Assesses linguistic and executive functions, including phonological and semantic fluency.
The score is the total number of correct words generated in 60 seconds.
Higher scores indicate better performance.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Stroop. Test of Colors and Words. Revised edition.
Time Frame: Baseline
|
It measures attention and executive functioning, specifically the ability to inhibit automatic responses and resist interference from established behavior patterns.
Scores are based on the number of correct responses completed in 45 seconds, depending on the condition.
Higher scores indicate better executive functioning.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Symbol Digit Modalities Test (SDMT)
Time Frame: 6 months
|
It assesses processing speed based on the total number of items completed in 90 seconds.
Scores range from 0 to a maximum determined by the speed of task completion.
Higher scores indicate better processing speed.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Continuous Performance Test, third edition (CPT-3)
Time Frame: 6 months
|
It assesses sustained visual attention, impulsivity, and vigilance through continuous performance tasks that require responses to target stimuli and inhibition of non-target stimuli.
Outcome measures include omission errors, commission errors, reaction time, and variability, which are expressed as standardized T-scores.
Higher T-scores indicate poorer performance.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Clinical Assessment of Memory (ECM)
Time Frame: 6 months
|
It assesses working memory and immediate memory in auditory-verbal and visuospatial modalities.
Scores are expressed as standardized scores based on Spanish norms.
Higher scores indicate better memory performance.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Stroop. Test of Colors and Words. Revised edition
Time Frame: 6 months
|
It measures attention and executive functioning, specifically the ability to inhibit automatic responses and resist interference from established behavior patterns.
Scores are based on the number of correct responses completed in 45 seconds, depending on the condition.
Higher scores indicate better executive functioning.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Verbal Fluency Test (VFT)
Time Frame: 6 months
|
Assesses linguistic and executive functions, including phonological and semantic fluency.
The score is the total number of correct words generated in 60 seconds.
Higher scores indicate better performance.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)
Time Frame: Baseline
|
63-item questionnaire that assesses the patient's executive functions (completed by parents).
Higher scores in each domain indicate a worse outcome.
Spanish norms in T scores (mean = 50; standard deviation = 10).
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Behavior Assessment System for Children, third edition (BASC-3)
Time Frame: Baseline
|
It measures patients' emotional and behavioral problems, both in the version completed by the patient's legal guardians and in the self-assessment carried out by the patient themselves.
It is a report of 139 items, scored on a 4-point Likert frequency scale.
High scores indicate problematic levels of functioning.
Scores are reported as T-scores (mean = 50; standard deviation = 10).
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Brief Pain Inventory (BPI)
Time Frame: Baseline
|
This 10-question questionnaire includes questions (from 0 to 10, referring to the last 7 days) covering two dimensions: pain intensity (the most intense and mildest pain of the week, average pain, and current pain) and pain interference (in general activity, mood, walking, school, sleep, and enjoyment of life).
Higher scores on a Likert scale of 0 to 10 indicate more pain.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Adolescent Insomnia Questionnaire (AIQ)
Time Frame: Baseline
|
This is a 13-item questionnaire, the original version of which is in English.
In this study, the questionnaire will be adapted and validated in Spanish.
Higher scores on a Likert scale of 0 to 4 indicate greater insomnia.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Pediatric Sleep Disturbances Short Form (PROMIS)
Time Frame: Baseline
|
A 4-question questionnaire that assesses problems falling asleep and staying asleep over the past 7 days.
Higher scores on a Likert scale of 1 to 5 indicate poorer sleep.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Child and Adolescent Mindfulness Measure (CAMM).
Time Frame: Baseline
|
Assesses mindfulness skills related to present moment awareness and nonjudgmental acceptance.
Total scores range from 0 to 40.
Higher scores indicate greater mindfulness ability.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
Baseline
|
|
Brain Functional Connectivity
Time Frame: Baseline
|
EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics.
|
Baseline
|
|
Biomarkers
Time Frame: Baseline
|
White blood cells, platelets, and C-reactive protein.
|
Baseline
|
|
Behavior Assessment System for Children, third edition (BASC-3)
Time Frame: 3 months
|
It measures patients' emotional and behavioral problems, both in the version completed by the patient's legal guardians and in the self-assessment carried out by the patient themselves.
It is a report of 139 items, scored on a 4-point Likert frequency scale.
High scores indicate problematic levels of functioning.
Scores are reported as T-scores (mean = 50; standard deviation = 10).
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
3 months
|
|
Brief Pain Inventory (BPI)
Time Frame: 3 months
|
This 10-question questionnaire includes questions (from 0 to 10, referring to the last 7 days) covering two dimensions: pain intensity (the most intense and mildest pain of the week, average pain, and current pain) and pain interference (in general activity, mood, walking, school, sleep, and enjoyment of life).
Higher scores on a Likert scale of 0 to 10 indicate more pain.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
3 months
|
|
Adolescent Insomnia Questionnaire (AIQ)
Time Frame: 3 months
|
This is a 13-item questionnaire, the original version of which is in English.
In this study, the questionnaire will be adapted and validated in Spanish.
Higher scores on a Likert scale of 0 to 4 indicate greater insomnia.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
3 months
|
|
Pediatric Sleep Disturbances Short Form (PROMIS)
Time Frame: 3 months
|
A 4-question questionnaire that assesses problems falling asleep and staying asleep over the past 7 days.
Higher scores on a Likert scale of 1 to 5 indicate poorer sleep.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
3 months
|
|
Child and Adolescent Mindfulness Measure (CAMM)
Time Frame: 3 months
|
Assesses mindfulness skills related to present moment awareness and nonjudgmental acceptance.
Total scores range from 0 to 40.
Higher scores indicate greater mindfulness ability.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
3 months
|
|
Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)
Time Frame: 6 months
|
63-item questionnaire that assesses the patient's executive functions (completed by parents).
Higher scores in each domain indicate a worse outcome.
Spanish norms in T scores (mean = 50; standard deviation = 10).
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Behavior Assessment System for Children, third edition (BASC-3)
Time Frame: 6 months
|
It measures patients' emotional and behavioral problems, both in the version completed by the patient's legal guardians and in the self-assessment carried out by the patient themselves.
It is a report of 139 items, scored on a 4-point Likert frequency scale.
High scores indicate problematic levels of functioning.
Scores are reported as T-scores (mean = 50; standard deviation = 10).
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Brief Pain Inventory (BPI)
Time Frame: 6 months
|
This 10-question questionnaire includes questions (from 0 to 10, referring to the last 7 days) covering two dimensions: pain intensity (the most intense and mildest pain of the week, average pain, and current pain) and pain interference (in general activity, mood, walking, school, sleep, and enjoyment of life).
Higher scores on a Likert scale of 0 to 10 indicate more pain.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Adolescent Insomnia Questionnaire (AIQ)
Time Frame: 6 months
|
This is a 13-item questionnaire, the original version of which is in English.
In this study, the questionnaire will be adapted and validated in Spanish.
Higher scores on a Likert scale of 0 to 4 indicate greater insomnia.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Pediatric Sleep Disturbances Short Form (PROMIS)
Time Frame: 6 months
|
A 4-question questionnaire that assesses problems falling asleep and staying asleep over the past 7 days.
Higher scores on a Likert scale of 1 to 5 indicate poorer sleep.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Child and Adolescent Mindfulness Measure (CAMM)
Time Frame: 6 months
|
Assesses mindfulness skills related to present moment awareness and nonjudgmental acceptance.
Total scores range from 0 to 40.
Higher scores indicate greater mindfulness ability.
The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement.
|
6 months
|
|
Brain Functional Connectivity
Time Frame: 6 months
|
EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics.
|
6 months
|
|
Biomarkers
Time Frame: 6 months
|
White blood cells, platelets, and C-reactive protein.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kamal M, Joseph J, Greenbaum U, Hicklen R, Kebriaei P, Srour SA, Wang XS. Patient-Reported Outcomes for Cancer Patients with Hematological Malignancies Undergoing Chimeric Antigen Receptor T Cell Therapy: A Systematic Review. Transplant Cell Ther. 2021 May;27(5):390.e1-390.e7. doi: 10.1016/j.jtct.2021.01.003. Epub 2021 Jan 7.
- Ragoonanan D, Sheikh IN, Gupta S, Khazal SJ, Tewari P, Petropoulos D, Li S, Mahadeo KM. The Evolution of Chimeric Antigen Receptor T-Cell Therapy in Children, Adolescents and Young Adults with Acute Lymphoblastic Leukemia. Biomedicines. 2022 Sep 14;10(9):2286. doi: 10.3390/biomedicines10092286.
- Caes L, Dick B, Duncan C, Allan J. The Cyclical Relation Between Chronic Pain, Executive Functioning, Emotional Regulation, and Self-Management. J Pediatr Psychol. 2021 Mar 18;46(3):286-292. doi: 10.1093/jpepsy/jsaa114.
- Ruark J, Mullane E, Cleary N, Cordeiro A, Bezerra ED, Wu V, Voutsinas J, Shaw BE, Flynn KE, Lee SJ, Turtle CJ, Maloney DG, Fann JR, Bar M. Patient-Reported Neuropsychiatric Outcomes of Long-Term Survivors after Chimeric Antigen Receptor T Cell Therapy. Biol Blood Marrow Transplant. 2020 Jan;26(1):34-43. doi: 10.1016/j.bbmt.2019.09.037. Epub 2019 Oct 9.
- Thompson J, Fisher B, Sung L, Dvorak C, Dang H, Lo T, Alexander S. Musculoskeletal impairments in children receiving intensive therapy for acute leukemia or undergoing hematopoietic stem cell transplant: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2021 Aug;68(8):e29053. doi: 10.1002/pbc.29053. Epub 2021 Apr 23.
- Barata A, Hoogland AI, Kommalapati A, Logue J, Welniak T, Hyland KA, Eisel SL, Small BJ, Jayani RV, Booth-Jones M, Oswald LB, Gonzalez BD, Kirtane KS, Jain MD, Mokhtari S, Chavez JC, Lazaryan A, Shah BD, Locke FL, Jim HSL. Change in Patients' Perceived Cognition Following Chimeric Antigen Receptor T-Cell Therapy for Lymphoma. Transplant Cell Ther. 2022 Jul;28(7):401.e1-401.e7. doi: 10.1016/j.jtct.2022.05.015. Epub 2022 May 14.
- Taylor MR, Steineck A, Lahijani S, Hall AG, Jim HSL, Phelan R, Knight JM. Biobehavioral Implications of Chimeric Antigen Receptor T-cell Therapy: Current State and Future Directions. Transplant Cell Ther. 2023 Jan;29(1):19-26. doi: 10.1016/j.jtct.2022.09.029. Epub 2022 Oct 5.
- Shalabi H, Gust J, Taraseviciute A, Wolters PL, Leahy AB, Sandi C, Laetsch TW, Wiener L, Gardner RA, Nussenblatt V, Hill JA, Curran KJ, Olson TS, Annesley C, Wang HW, Khan J, Pasquini MC, Duncan CN, Grupp SA, Pulsipher MA, Shah NN. Beyond the storm - subacute toxicities and late effects in children receiving CAR T cells. Nat Rev Clin Oncol. 2021 Jun;18(6):363-378. doi: 10.1038/s41571-020-00456-y. Epub 2021 Jan 25.
- Di Giuseppe G, Thacker N, Schechter T, Pole JD. Anxiety, depression, and mental health-related quality of life in survivors of pediatric allogeneic hematopoietic stem cell transplantation: a systematic review. Bone Marrow Transplant. 2020 Jul;55(7):1240-1254. doi: 10.1038/s41409-020-0782-z. Epub 2020 Jan 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2025
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
December 30, 2027
Study Registration Dates
First Submitted
February 17, 2026
First Submitted That Met QC Criteria
March 14, 2026
First Posted (Actual)
March 18, 2026
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 14, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI23/00179
- 2023.832 (Other Identifier: Hospital Universitario La Paz)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.