NCT07479927 Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
| NCT ID | NCT07479927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario La Paz |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-12-19 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07479927 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07479927 currently recruiting?
Yes, NCT07479927 is actively recruiting participants. Contact the research team at eduferjim.psyc@gmail.com for enrollment information.
Where is the NCT07479927 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07479927 clinical trial?
NCT07479927 is sponsored by Hospital Universitario La Paz. The trial plans to enroll 40 participants.
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