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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-26

Study Completion Date

2025-05-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Transplant-Related Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Allogeneic hematopoietic stem cell transplantation

Patients in waiting list for and after allogeneic hematopoietic stem cell transplantation.

Allogeneic hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Allogeneic hematopoietic stem cell transplantation

Solid organ transplantation

Patients in waiting list for and after solid organ transplantation.

Solid organ transplantation

Intervention Type PROCEDURE

Solid organ transplantation

Interventions

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Allogeneic hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Solid organ transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Spanish as mother tongue or a very high level of Spanish in order to understand their participation in the study, as well as to be able to complete the measurement instruments.

Exclusion Criteria

* Diagnosis of intellectual disability, autism spectrum disorder or acquired brain damage.
* Diagnosis of uncontrolled/stabilised comorbid disease, independent of the disease motivating the transplantation process.

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No