Clinical trial NCT03361033: Components of Social Functioning in Survivors of Pediatric Brain Tumors
Official title: Components of Social Functioning in Survivors of Pediatric Brain Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor, Pediatric
Medulloblastoma, Pediatric
Keywords: Survivorship
Social Functioning
Social Outcomes
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-12-04
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Significant predictors of social-cognitive and neurocognitive abilities on social functioning
timeFrame: From enrollment through up to 7 days later
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Heather Conklin, PhD
role: PRINCIPAL_INVESTIGATOR
References: