Acute Lymphoblastic LeukemiaPsyCARTkidsNCT07479927
Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
A study testing Digital cognitive training and Online Mindfulness-Based Intervention in people with Acute Lymphoblastic Leukemia, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Digital cognitive training and Online Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 19 Dec 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
- Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Eduardo Fernández-Jiménez, PhD, +34917277417, eduferjim.psyc@gmail.com
Cristina Campoy Lacasa, 2108965970, cristinacampoylacasa@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Digital cognitive training, Online Mindfulness-Based Intervention
- Keywords
- Acute lymphoblastic leukemia, CAR T-cell therapy, Pediatric oncology, Neuropsychology, Mindfulness, Biopsychosocial outcomes
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cognitive trainingBehavioural
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 InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Cognitive Training → Mindfulness | Experimental | Participants receive digital cognitive training followed by a mindfulness-based intervention delivered online. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (21)
Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)
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.
Measured: Baseline
Behavior Assessment System for Children, third edition (BASC-3)
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.
Measured: Baseline
Brief Pain Inventory (BPI)
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.
Measured: Baseline
Adolescent Insomnia Questionnaire (AIQ)
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.
Measured: Baseline
Pediatric Sleep Disturbances Short Form (PROMIS)
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.
Measured: Baseline
Child and Adolescent Mindfulness Measure (CAMM).
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.
Measured: Baseline
Brain Functional Connectivity
EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics.
Measured: Baseline
Biomarkers
White blood cells, platelets, and C-reactive protein.
Measured: Baseline
Behavior Assessment System for Children, third edition (BASC-3)
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.
Measured: 3 months
Brief Pain Inventory (BPI)
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.
Measured: 3 months
Adolescent Insomnia Questionnaire (AIQ)
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.
Measured: 3 months
Pediatric Sleep Disturbances Short Form (PROMIS)
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.
Measured: 3 months
Child and Adolescent Mindfulness Measure (CAMM)
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.
Measured: 3 months
Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)
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.
Measured: 6 months
Behavior Assessment System for Children, third edition (BASC-3)
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.
Measured: 6 months
Brief Pain Inventory (BPI)
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.
Measured: 6 months
Adolescent Insomnia Questionnaire (AIQ)
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.
Measured: 6 months
Pediatric Sleep Disturbances Short Form (PROMIS)
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.
Measured: 6 months
Child and Adolescent Mindfulness Measure (CAMM)
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.
Measured: 6 months
Brain Functional Connectivity
EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics.
Measured: 6 months
Biomarkers
White blood cells, platelets, and C-reactive protein.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start19 Dec 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized block design (based on the BRIEF-2 Emotional Regulation Index score), waitlist control group and counterbalanced intervention sequences.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz
- Responsible party
- Principal investigator, Dr. Eduardo Fernández-Jiménez, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479927
- Sponsor's protocol ID
- PI23/00179
- Other IDs
- 2023.832
- Acronym
- PsyCARTkids
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36140387Caes 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.
PubMed 33249502Kamal 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.
PubMed 33965176Ruark 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.
PubMed 31605820Thompson 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.
PubMed 33890409Barata 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.
PubMed 35580732Taylor 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.
PubMed 36208728Shalabi 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.
PubMed 33495553Di 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.
PubMed 31980743
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07479927
- Acronym / sponsor ID
- PsyCARTkids / PI23/00179
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute lymphoblastic leukemia, CAR T-cell therapy, Pediatric oncology, Neuropsychology, Mindfulness, Biopsychosocial outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Instituto de Investigación Hospital Universitario La Paz
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized block design (based on the BRIEF-2 Emotional Regulation Index score), waitlist control group and counterbalanced intervention sequences.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training → Mindfulness | Experimental | Behavioral: Digital cognitive training, Behavioral: Online Mindfulness-Based InterventionParticipants receive digital cognitive training followed by a mindfulness-based intervention delivered online. |
| Mindfulness → Cognitive Training | Experimental | Behavioral: Digital cognitive training, Behavioral: Online Mindfulness-Based InterventionParticipants receive a mindfulness-based intervention delivered online followed by digital cognitive training. |
| Waitlist Control | No intervention | –Participants do not receive the intervention during the main study period and are offered the full program after study completion. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
- Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital cognitive trainingAdaptive 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. | Behavioural | Cognitive Training → Mindfulness, Mindfulness → Cognitive Training |
| Online Mindfulness-Based InterventionAdapted 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. | Behavioural | Cognitive Training → Mindfulness, Mindfulness → Cognitive Training |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
21 secondary outcomes
Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)
Time frame: Baseline
Behavior Assessment System for Children, third edition (BASC-3)
Time frame: Baseline
Brief Pain Inventory (BPI)
Time frame: Baseline
Adolescent Insomnia Questionnaire (AIQ)
Time frame: Baseline
Pediatric Sleep Disturbances Short Form (PROMIS)
Time frame: Baseline
Child and Adolescent Mindfulness Measure (CAMM).
Time frame: Baseline
Brain Functional Connectivity
Time frame: Baseline
Biomarkers
Time frame: Baseline
Behavior Assessment System for Children, third edition (BASC-3)
Time frame: 3 months
Brief Pain Inventory (BPI)
Time frame: 3 months
Adolescent Insomnia Questionnaire (AIQ)
Time frame: 3 months
Pediatric Sleep Disturbances Short Form (PROMIS)
Time frame: 3 months
Child and Adolescent Mindfulness Measure (CAMM)
Time frame: 3 months
Behavior Rating Inventory of Executive Function, second edition (BRIEF-2)
Time frame: 6 months
Behavior Assessment System for Children, third edition (BASC-3)
Time frame: 6 months
Brief Pain Inventory (BPI)
Time frame: 6 months
Adolescent Insomnia Questionnaire (AIQ)
Time frame: 6 months
Pediatric Sleep Disturbances Short Form (PROMIS)
Time frame: 6 months
Child and Adolescent Mindfulness Measure (CAMM)
Time frame: 6 months
Brain Functional Connectivity
Time frame: 6 months
Biomarkers
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 36140387Ragoonanan 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.
- Background: PubMed 33249502Caes 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.
- Background: PubMed 33965176Kamal 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.
- Background: PubMed 31605820Ruark 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.
- Background: PubMed 33890409Thompson 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.
- Background: PubMed 35580732Barata 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.
- Background: PubMed 36208728Taylor 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.
- Background: PubMed 33495553Shalabi 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.
- Background: PubMed 31980743Di 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital cognitive training and Online Mindfulness-Based Intervention in people with Acute Lymphoblastic Leukemia, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Fernandez Jimenes, Phd (+34917277417, eduferjim.psyc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symbol Digit Modalities Test (SDMT). (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07479927, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.