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Neuropsychological and Biopsychosocial Evolution During Pediatric Transplantation: Pre/Post-stages and at 6 Months

NCT05441436 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-07-01

No results posted yet for this study

Summary

This pioneering prospective observational study aims to examine biopsychosocial and neuropsychological functioning, care needs and predictors of therapeutic adherence in children/adolescents in pre/post-surgical transplant (solid organ or allogeneic haematopoietic stem cell) phases. Hypothesis: H1. Differences in biopsychosocial and neuropsychological functioning and adherence will be observed between transplant types; H2. Executive functioning will mediate the relationship between anxiety, sleep disturbance and pain intensity/interference and adherence; H3. There will be a significant improvement in different neuropsychological indicators 6 months post-transplantation. Sample: patients (8-18 years) extracted by non-probabilistic sampling, estimating a sample size of 60 patients (30 for each type of transplant, organ and haematopoietic) from Hospital Universitario La Paz (Madrid). Individual pre/post-surgical assessments will be carried out (after 2 and 4 weeks), as well as at 6 months post-transplant, both in person (neurocognitive) and through the secure platform REDCap (completed by patients and their legal guardians). Finally, focus groups will be conducted among patients, their relatives and medical-surgical professionals to identify barriers to therapeutic adherence and unmet care needs during the pre-, peri- and post-surgical process.

Conditions

  • Transplant-Related Disorder

Interventions

PROCEDURE

Allogeneic hematopoietic stem cell transplantation

Allogeneic hematopoietic stem cell transplantation

PROCEDURE

Solid organ transplantation

Solid organ transplantation

Sponsors & Collaborators

  • University of Malaga

    collaborator OTHER

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Eduardo Fernández-Jiménez, PhD · Hospital Universitario La Paz

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2025-05-26
Completion
2025-05-26

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441436 on ClinicalTrials.gov