Components of Social Functioning in Survivors of Pediatric Brain Tumors

NCT03361033 | Completed

• 2 other identifiers: SOCFUNNCI-2021-05595
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor, Pediatric; Medulloblastoma, Pediatric

Keywords

Survivorship; Social Functioning; Social Outcomes

Outcome Measures

Primary Outcomes (1)

• Significant predictors of social-cognitive and neurocognitive abilities on social functioning

  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.

  From enrollment through up to 7 days later

Study Arms (2)

Medulloblastoma

Participants who are survivors of pediatric medulloblastoma and who meet eligibility criteria will be approached for their consent to participate in this study. Observational data will be collected through the administration of standard psychological questionnaires. If the participant consents, their parents, teachers and best friends will also be asked to complete questionnaires. In addition, participants will complete an online daily diary assessment of their social interactions for seven days.

Other Brain Tumors

Participants who are survivors of other pediatric brain tumors (excluding medulloblastoma and craniopharyngioma), who have not been treated with craniospinal irradiation (CSI), and who meet eligibility criteria will be approached for their consent to participate in this study. Observational data will be collected through the administration of standard psychological questionnaires. If the participant consents, their parents, teachers and best friends will also be asked to complete questionnaires. In addition, participants will complete an online daily diary assessment of their social interactions for seven days.

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be recruited from the outpatient Neuro-Oncology, Radiation Oncology, and After Completion of Therapy Clinics at St. Jude Children's Research Hospital. Children diagnosed with either a medulloblastoma or other brain tumor, between the ages of 8 and 12 years, and at least 2 years off-therapy will be eligible for participation.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Brain Neoplasms; Medulloblastoma; Social Adjustment

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Social Behavior; Behavior

Study Officials

• Heather Conklin, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: January 30, 2018
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)