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Components of Social Functioning in Survivors of Pediatric Brain Tumors

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ClinicalTrials.gov Identifier: NCT03361033
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.


Condition or disease
Brain Tumor, Pediatric Medulloblastoma, Pediatric

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Components of Social Functioning in Survivors of Pediatric Brain Tumors
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361033


Contacts
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Contact: Victoria W. Willard, PhD 866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Victoria W. Willard, PhD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Victoria W. Willard, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
American Cancer Society, Inc.
Investigators
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Principal Investigator: Victoria W. Willard, PhD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03361033     History of Changes
Other Study ID Numbers: SOCFUN
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Survivorship
Social Functioning
Social Outcomes

Additional relevant MeSH terms:
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Brain Neoplasms
Medulloblastoma
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