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OpenTrials
Completed

NCT Number: NCT03361033

Components of Social Functioning in Survivors of Pediatric Brain Tumors

Children with brain tumors are at risk for a number of psychological late effects, including neurocognitive and social deficits. This observational study focuses on assessment of social functioning, including social-cognitive and neurocognitive abilities, in survivors of pediatric brain tumors. This study will also assess the influence of medical factors, including diagnosis and age at diagnosis, on social functioning.

PRIMARY OBJECTIVE: Examine the impact of social-cognitive and neurocognitive abilities on social functioning in survivors of pediatric brain tumors.

SECONDARY OBJECTIVE: Assess the influence of medical factors such as diagnosis and age at diagnosis on the social functioning of survivors of pediatric brain tumors.

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Key information

About this study

Assessment of social and neurocognitive functioning in survivors of pediatric brain tumors who are least two years post-therapy and between 8 and 12 years of age will be included. Participants will be recruited from two tumor types: 1) medulloblastoma, and 2) other brain tumors that were not treated with craniospinal irradiation. Upon enrollment, participants will complete standard psychological questionnaires used to evaluate both performance-based and self-report measures of social and neurocognitive functioning. Parents will complete questionnaires. Families will be asked for permission to contact teachers to complete additional questionnaires. Children will identify their best friend as part of their questionnaires and will be asked permission to contact this friend to complete two questionnaires. Finally, children will be asked to complete an online daily diary of social interactions for seven days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of medulloblastoma or other brain tumor
  • Current age between 8 and 12 years, inclusive
  • At least 2 years post-completion of therapy
  • Enrolled in school full-time
  • English speaking
  • Cognitive and language capacity to complete measures
  • Teacher inclusion: Consent received from survivor and parent to contact.
  • Best Friends inclusion: (1) Consent received from survivor and parent to contact, (2) English-speaking, (3) Cognitive capacity to complete questionnaires as judged by the parent during the consent process.

Exclusion criteria

  • Diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., autism, Neurofibromatosis Type 1 (NF1), Down syndrome
  • Homeschooled or full-time special education
  • IQ less than 70 as documented in the medical record
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  • Other tumor cohort exclusion: (1) diagnosis of craniopharyngioma, (2) treatment history includes craniospinal irradiation (CSI).

Treatment and study plan

Primary outcomes

  1. Significant predictors of social-cognitive and neurocognitive abilities on social functioning

    Time frame: From enrollment through up to 7 days later

    The primary outcome is social interaction which will be assessed via a Daily Diary that documents an individual's positive and negative social interactions, averaged over 7 days. All participants will be evaluated for the primary outcome, and descriptive statistics will be estimated to characterize the sample across all measures.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2017
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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