Brain Tumor, PediatricNCT03361033
Components of Social Functioning in Survivors of Pediatric Brain Tumors
An observational study of Brain Tumor, Pediatric and Medulloblastoma, Pediatric, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Brain Tumor, Pediatric, Medulloblastoma, Pediatric
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 17 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Brain Tumor, Pediatric, Medulloblastoma, Pediatric
- Keywords
- Survivorship, Social Functioning, Social Outcomes
- Medical subject headings
- Brain Neoplasms, Medulloblastoma, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through up to 7 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start30 Jan 2018
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PediatricStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Heather Conklin, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361033
- Sponsor's protocol ID
- SOCFUN
- Other IDs
- NCI-2021-05595
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2017
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Components of Social Functioning in Survivors of Pediatric Brain Tumors
- ClinicalTrials.gov ID
- NCT03361033
- Acronym / sponsor ID
- SOCFUN
- Conditions
- Brain Tumor, Pediatric, Medulloblastoma, Pediatric
- Keywords
- Survivorship, Social Functioning, Social Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Conklin, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, Pediatric and Medulloblastoma, Pediatric, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant predictors of social-cognitive and neurocognitive abilities on social functioning (time frame: From enrollment through up to 7 days later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.