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.
Study Type
OBSERVATIONAL
Enrollment
60
Allogeneic hematopoietic stem cell transplantation
Solid organ transplantation
Hospital Universitario La Paz. Hospital infantil
Madrid, Spain
RECRUITINGUniversity of Málaga
Málaga, Spain
ACTIVE_NOT_RECRUITINGInitial survey created ad hoc
Both sociodemographic variables (sex, age, patient's level of studies, parents' level of studies) and clinical variables (current pharmacological treatment - active ingredient and dose) will be collected.
Time frame: Baseline
Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)
A 63-item questionnaire that assesses 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).
Time frame: Baseline
Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)
A 63-item questionnaire that assesses 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).
Time frame: 6 months
Spanish version of the California Verbal Learning Test for children (TAVECI)
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements.
Time frame: Baseline
Spanish version of the California Verbal Learning Test (TAVEC)
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements.
Time frame: Baseline
Spanish version of the California Verbal Learning Test for children (TAVECI)
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements.
Time frame: 6 months
Spanish version of the California Verbal Learning Test (TAVEC)
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements.
Time frame: 6 months
Conners Continuous Auditory Test of Attention (CATA)
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Time frame: Baseline
Conners Continuous Auditory Test of Attention (CATA)
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Time frame: 4 weeks
Conners Continuous Auditory Test of Attention (CATA)
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Time frame: 6 months
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form A
It assesses intellectual functioning free of cultural influences by the total number of items achieved.
Time frame: Baseline
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form B
It assesses intellectual functioning free of cultural influences by the total number of items achieved.
Time frame: 6 months
Digit span subtests from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV): Forward, Backward and Sequencing subtests
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
Time frame: Baseline
Digit span subtests from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV): Forward, Backward and Sequencing subtests
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
Time frame: 4 weeks
Digit span subtests from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV): Forward, Backward and Sequencing subtests
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
Time frame: 6 months
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
It measures semantic memory by the total number of items achieved.
Time frame: Baseline
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
It measures semantic memory by the total number of items achieved.
Time frame: 6 months
Symbol Digit Modalities Test (SDMT)
It assesses processing speed by the total number of items achieved.
Time frame: Baseline
Symbol Digit Modalities Test (SDMT)
It assesses processing speed by the total number of items achieved.
Time frame: 4 weeks
Symbol Digit Modalities Test (SDMT)
It assesses processing speed by the total number of items achieved.
Time frame: 6 months
The Rey-Osterrieth Complex Figure (ROCF) test
It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced.
Time frame: Baseline
The Rey-Osterrieth Complex Figure (ROCF) test
It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced.
Time frame: 6 months
Fluency Verbal Test (TFV)
It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced.
Time frame: Baseline
Fluency Verbal Test (TFV)
It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced.
Time frame: 6 months
Behavioral Assessment System for Children - 3 (BASC-3)
It measures patients' emotional and behavioural problems, both in its version by the patient's legal guardians and self-reported by the patient. It is an 139-item report, rated on a 4-point frequency Likert scale. High scores indicate problematic levels of functioning. Spanish norms in T scores (Mean = 50; standard deviation = 10).
Time frame: Baseline
Behavioral Assessment System for Children - 3 (BASC-3)
It measures patients' emotional and behavioural problems, both in its version by the patient's legal guardians and self-reported by the patient. It is an 139-item report, rated on a 4-point frequency Likert scale. High scores indicate problematic levels of functioning. Spanish norms in T scores (Mean = 50; standard deviation = 10).
Time frame: 6 months
Brief Pain Inventory (BPI)
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain.
Time frame: Baseline
Brief Pain Inventory (BPI)
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain.
Time frame: 2 weeks
Brief Pain Inventory (BPI)
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain.
Time frame: 4 weeks
Brief Pain Inventory (BPI)
This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain.
Time frame: 6 months
Adolescent Insomnia Questionnaire (AIQ)
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia.
Time frame: Baseline
Adolescent Insomnia Questionnaire (AIQ)
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia.
Time frame: 2 weeks
Adolescent Insomnia Questionnaire (AIQ)
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia.
Time frame: 4 weeks
Adolescent Insomnia Questionnaire (AIQ)
It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia.
Time frame: 6 months
Pediatric Sleep Disturbances Short Form (PROMIS)
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep.
Time frame: Baseline
Pediatric Sleep Disturbances Short Form (PROMIS)
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep.
Time frame: 2 weeks
Pediatric Sleep Disturbances Short Form (PROMIS)
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep.
Time frame: 4 weeks
Pediatric Sleep Disturbances Short Form (PROMIS)
A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep.
Time frame: 6 months
Simplified Medication Adherence Questionnaire (SMAQ)
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient.
Time frame: Baseline
Simplified Medication Adherence Questionnaire (SMAQ)
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient.
Time frame: 2 weeks
Simplified Medication Adherence Questionnaire (SMAQ)
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient.
Time frame: 4 weeks
Simplified Medication Adherence Questionnaire (SMAQ)
A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.