Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05709522 |
| Other study ID # |
2021-4859-18168. |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 20, 2020 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Aga Khan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
