Trial Title:
Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients
NCT ID:
NCT05709522
Condition:
Brain Tumor, Pediatric
Blood Cancer
Conditions: Official terms:
Brain Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
Pediatric Brain tumor
Blood Cancer
Neurocognition
Psychosocial outcomes
Quality of life
depression
socioeconomic burden
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Neurocognitive tools
Description:
Neurocognitve and psychological tools
Arm group label:
Blood cancer children
Arm group label:
Pediatric brain tumor patients
Other name:
Psychosocial tools
Summary:
This will be the first in-depth study to evaluate pretreatment and 12 months
post-treatment, neurocognitive and psychological outcomes of children with brain tumor
and blood cancer in Pakistan. The investigators will also determine the socioeconomic
burden of pediatric brain tumors in low middle-income region and the association of micro
RNA and protein markers with neurocognitive outcomes in PBT and blood cancer children. A
prospective cohort study with a follow-up of 12 months at the Aga Khan University
Hospital, Karachi, Pakistan and Jinnah postgraduate Medical Centre , Karachi, Pakistan
will be conducted. After taking consent/ assent the investigators will recruit 80, 5-21
years old children with newly diagnosed brain tumors presenting with any stage, who have
not undergone any treatment. Trained psychologist will assess the neurocognitive outcomes
by the Slosson scale, Raven's progressive matrices and Wechsler Intelligence Scale for
children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV) tools. The Quality of
life and depression of the children will be determined by PedQL and Revised Children's
Anxiety and Depression Scale (RCADS) and hospital anxiety and depression scale (HADs)
respectively . The financial burden of the disease on the family will be measured on a
visual analog scale ranging from no burden (0) to very large burden (100) and the parents
QoL and disrupted schedule, financial problems, lack of family support, health problems
and the impact of caregiving on caregiver's self-esteem will be assessed by Pediatric
Quality of Life Inventory PedQl (family module) and Caregiver Reaction Assessment (CRA)
tools respectively. The serum micro RNA (mi-21, mi-10b and mi-210) and protein markers
(GFAP, NSE and S100β) will be assessed by qRT-PCR and ELISA.
Detailed description:
Rationale: The synergy between poverty, socio-cultural, psychosocial and biological risk
factors influences neurocognitive outcomes in children. In a LMIC like ours where
children are growing up at a disadvantage, it is important the child's future potential
and productivity. To the best of the investigators knowledge limited information, there
is no data in this area from Pakistan. Data to assess the neurocognitive and
psychological outcomes of children during this vulnerable period and to design
interventions which may help to improve from this study will be enable the assessment of
direction and magnitude of effects, identify high risk children whom would benefit from
individual treatment and, with this knowledge, enhance family support Study Design and
Site A prospective cohort study with a follow-up of 12 months. The study will be
conducted at the Aga Khan University Hospital (AKUH) and Jinnah post graduate Medical
Centre (JPMC). The participants will be recruited from the neurosurgery/oncology clinics.
Study Participants The study participants will be 5 to 21 years old children with newly
diagnosed brain tumors and blood cancer presenting with any stage, who have not undergone
any treatment
Sampling strategy Purposive sampling technique will be used for selecting the
participants. The target population, that is, brain tumor and blood cancer children who
have not received cancer treatment, will be approached by trained psychologist.
Sample size: With a mean difference of neurocognitive outcome ranging from 15 to 23 and
difference of standard deviation ranging from 14 to 27, from pretreatment to 12 months
post treatment .And with a mean difference of Quality of life ranging from 9 to 16 and
difference of standard deviation ranging from 18 to 19 . With a power of 80% and level of
significance of 5%. However, the investigators calculated the sample size using two
population mean in order to compare the mean neurocognitive and psychological scores of
the two groups. With an anticipated mean difference of 6, a standard deviation of 15 for
the two groups, a level of significance of 5%, and power of 80%. Therefore the final
sample size will be 80 patients ( 40 pediatric brain tumor patients and 40 blood cancer
patients), with a 10% inflation for loss to follow-up
Data collection The children with brain tumor and blood cancer will be recruited from the
surgery/ pediatric oncology clinics AKUH. Screening tool will be administered for
eligibility of the study participant for the study. The Pediatric Quality of Life
Inventory , PedsQL family information form will be completed by the parents that contains
demographic information required to calculate Hollingshead socioeconomic status (SES).
Information will also be collected on; tumor and treatment related factors,
histopathology, family history, nutritional status, consanguinity and perinatal risk
factors and molecular expression analysis chart on a structured questionnaire for
pediatric brain tumor patients and blood cancer patients
The neurocognitive outcomes of the eligible children will be assessed by a psychologist
at baseline i.e., before treatment and 12 months post-treatment. It will be assessed by
the Slosson Intelligence tool Revised 3rd edition (SIT-R3) and Raven's Progressive
Matrices (RPM).The progressing speed will be assessed by Wechsler Intelligence Scale for
children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV)
Plan of Analysis Data will be analyzed using STATA version 15. Results will be presented
as mean and standard error/ median , interquartile range (IQR) for cognitive outcomes,
quality of life (QoL) scores and financial burden scores. Pretreatment and 12 months post
treatment scores will be assessed by paired t test/ wilcoxon sign rank test as
appropriate. Categorical variables will be reported as frequency and percentages and will
be assessed by chi-square/ fisher exact test. Correlation analysis will be preformed to
assess relationship of child's neurocognitive outcome scores with QoL scores and child's
QoL scores with the parents QoL scores. Unadjusted and adjusted beta coefficient with 95%
CI will be reported by using Linear mixed effects models (LMEMs) to determine the
association of various independent factors such as child factors (demographic factors),
parental factors (educational status, socioeconomic status, prenatal exposure/
infections) , tumor and treatment related factors with the neurocognitive outcomes and
QoL. We will adjust for the independent variables and determine the association of
factors causing a greater decline in outcomes by multivariable Linear mixed effects
models (LMEMs) . Plausible interactions will also be assessed. A p value of < 0.05 will
be considered as significant throughout the study
Criteria for eligibility:
Study pop:
5-21 years old pediatric brain tumor and blood cancer patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. 5-21 years children with brain tumor, presenting with any stage
2. Children residing in Pakistan for at least 3 months.
3. Children accompanied by both or either of the parent
4. Children with basic understanding of English
5. Children and their parents who understand and speak in Urdu
6. Children and their parents who will give assent / consent to participate in the
study
Exclusion Criteria:
1. Children who have received any type of treatment for brain tumor and blood cancer
2. Children presenting with recurrence
3. Children with metastatic brain tumor and blood cancer
4. Known cases of any illness leading to psychiatric/neurological illness (e.g. ADHD,
autism, schizophrenia) as confirmed by medical records, will be excluded from the
study as they may be on medications that might distort the results.
5. Children with physical comorbidities and debilitating disease
6. Children who will loss to follow-up
-
Gender:
All
Minimum age:
5 Years
Maximum age:
21 Years
Locations:
Facility:
Name:
Nida Zahid
Address:
City:
Karachi
Zip:
74800
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Nida Zahid
Phone:
03002331924
Email:
nida.zahid@aku.edu
Investigator:
Last name:
Andreas Martensson
Email:
Sub-Investigator
Investigator:
Last name:
Nick Brown
Email:
Sub-Investigator
Investigator:
Last name:
Syed Ather Enam
Email:
Sub-Investigator
Investigator:
Last name:
Naureen Mushtaque
Email:
Sub-Investigator
Investigator:
Last name:
Muhammad Nouman Mughal
Email:
Sub-Investigator
Investigator:
Last name:
Mariya Moochaala
Email:
Sub-Investigator
Investigator:
Last name:
Sadaf Altaf
Email:
Sub-Investigator
Investigator:
Last name:
Salman Kiramani
Email:
Sub-Investigator
Investigator:
Last name:
Lal Rehman
Email:
Sub-Investigator
Investigator:
Last name:
Farrukh Javed
Email:
Sub-Investigator
Start date:
November 20, 2020
Completion date:
November 30, 2023
Lead sponsor:
Agency:
Aga Khan University
Agency class:
Other
Collaborator:
Agency:
Jinnah Postgraduate Medical Centre
Agency class:
Other
Source:
Aga Khan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05709522
