Components of Social Functioning in Survivors of Pediatric Brain Tumors

Brain Tumor, Pediatric Clinical Trial

Official title:

Components of Social Functioning in Survivors of Pediatric Brain Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03361033
• Other study ID #: SOCFUN
• Secondary ID: NCI-2021-05595
• Status: Active, not recruiting
• Start date: January 30, 2018
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 2025
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Pediatric
• Medulloblastoma
• Medulloblastoma, Pediatric

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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