Components of Social Functioning in Survivors of Pediatric Brain Tumors

NCT ID: NCT03361033

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-30

Study Completion Date

2022-10-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Tumor, Pediatric Medulloblastoma, Pediatric

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Conklin, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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NCI-2021-05595

Identifier Type: REGISTRY

Identifier Source: secondary_id

SOCFUN

Identifier Type: -

Identifier Source: org_study_id

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