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Recruiting NCT05709522

Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor and Blood Cancer Patients

Conditions: Brain Tumor, Pediatric, Blood Cancer

Sex: All
Ages: 5 Years – 21 Years
Enrollment: 80
Sponsor: Aga Khan University

Location: Pakistan

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.

Eligibility Criteria

Inclusion Criteria:5-21 years children with brain tumor, presenting with any stageChildren residing in Pakistan for at least 3 months.Children accompanied by both or either of the parentChildren with basic understanding of EnglishChildren and their parents who understand and speak in UrduChildren and their parents who will give assent / consent to participate in the studyExclusion Criteria:Children who have received any type of treatment for brain tumor and blood cancerChildren presenting with recurrenceChildren with metastatic brain tumor and blood cancerKnown 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.Children with physical comorbidities and debilitating diseaseChildren who will loss to follow-up-

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05709522). StuddyBuddy aggregates publicly available trial information.