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

NCT07479927 | Recruiting

• 2 other identifiers: PI23/001792023.832
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Acute Lymphoblastic Leukemia

Keywords

Acute lymphoblastic leukemia; CAR T-cell therapy; Pediatric oncology; Neuropsychology; Mindfulness; Biopsychosocial outcomes

Outcome Measures

Primary Outcomes (10)

• Symbol Digit Modalities Test (SDMT).

  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)

  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)

  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)

  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.

  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)

  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)

  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)

  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

  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)

  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 Outcomes (21)

• Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)

  Baseline

• Behavior Assessment System for Children, third edition (BASC-3)

  Baseline

• Brief Pain Inventory (BPI)

  Baseline

• Adolescent Insomnia Questionnaire (AIQ)

  Baseline

• Pediatric Sleep Disturbances Short Form (PROMIS)

  Baseline

Study Arms (3)

Cognitive Training → Mindfulness

EXPERIMENTAL

Participants receive digital cognitive training followed by a mindfulness-based intervention delivered online.

Behavioral: Digital cognitive training; Behavioral: Online Mindfulness-Based Intervention

Mindfulness → Cognitive Training

EXPERIMENTAL

Participants receive a mindfulness-based intervention delivered online followed by digital cognitive training.

Behavioral: Digital cognitive training; Behavioral: Online Mindfulness-Based Intervention

Waitlist Control

NO INTERVENTION

Participants do not receive the intervention during the main study period and are offered the full program after study completion.

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.

Cognitive Training → Mindfulness; Mindfulness → Cognitive Training

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.

Cognitive Training → Mindfulness; Mindfulness → Cognitive Training

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
• Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• Instituto de Investigación Hospital Universitario La Paz: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 36140387 BACKGROUND

• 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.

  PMID: 33249502 BACKGROUND

• 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.

  PMID: 33965176 BACKGROUND

• 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.

  PMID: 31605820 BACKGROUND

• 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.

  PMID: 33890409 BACKGROUND

• 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.

  PMID: 35580732 BACKGROUND

• 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.

  PMID: 36208728 BACKGROUND

• 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.

  PMID: 33495553 BACKGROUND

• 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.

  PMID: 31980743 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Eduardo Fernandez Jimenes, Phd

CONTACT

+34917277417; eduferjim.psyc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Model Details: Randomized block design (based on the BRIEF-2 Emotional Regulation Index score), waitlist control group and counterbalanced intervention sequences.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 18, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

ES (1)