SEDYC: Social and Emotional Development in Children with Cancer

Category:

Psychology

Diseases Treated:

Non-therapeutic

Eligibility Overview:

This is a non-therapeutic research study open only to St. Jude patients, their parents and patients' teachers.

  • Patient between 4 and 6 years old
  • Primary diagnosis of brain tumor or non-CNS solid tumor
  • 6 to 12 months since therapy was completed
  • Chemotherapy was part of tumor treatment
  • Able to speak and read English
  1. Brief Summary

    Children with brain tumors are at risk for a number of psychological late effects, including neurocognitive and social deficits. A key risk factor for the development of these deficits is young age at diagnosis. In typically-developing children, the early childhood and preschool years are critical for the development of social skills like problem solving and emotion regulation. These skills are typically learned and practiced with other same-aged peers in social environments, such as playgrounds and preschool classrooms. It is unknown how and when these skills may develop in children who are not exposed to these environments.

    This study will use questionnaires and other activities to assess the impact of missed early childhood social experiences, as well as the relationship with developing neurocognitive problems in children with brain tumors. Through the use of a comparison group of children with solid tumors, we will attempt to begin to isolate the impact of missed experiences versus neurocognitive concerns.

    Primary Objective

    • To explore the impact of cancer in the central nervous system on social functioning of young children (ages 4 to 6) after completion of therapy

    Secondary Objective:

    • To explore the impact of cancer in the central nervous system on social functioning of young children (ages 4 to 6) over time

    Eligibility Criteria

    Inclusion criteria include:

    • Between 4 and 6 years old at enrollment
    • Primary diagnosis of brain tumor or non-CNS solid tumor
    • 6 to 12 months since therapy was completed
    • Chemotherapy was part of tumor treatment
    • Able to speak and read English

    Exclusion Criteria include:

    • Diagnosis of advanced disease, defined as M+ status in children with brain tumors and Stage 4 in children with solid tumors
    • Diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., autism, neurofibromatosis Type 1, Down syndrome)
    • Solid tumor patients who required CNS-directed therapy (e.g., radiation, intrathecal chemotherapy)

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    Young children who are treated for brain tumors may develop social, emotional and thinking problems as they grow older. Researchers want to learn as much as possible about these changes and how cancer treatment may affect these children later in life. This knowledge may help doctors improve care for children undergoing cancer treatment in the future.

    Researchers in this study will survey social, thinking and reasoning skills of young children who completed treatment for cancer at St. Jude Children’s Research Hospital. Young patients, their parents and a teacher will be asked to participate. In two years, researchers will ask each participant to complete a second study visit to again study social skills as well as thinking and reasoning.

    Purpose of this clinical trial

    The main goal of this study is to help researchers understand the social and emotional development of young children undergoing cancer treatment.

    Eligibility overview

    • Between 4 and 6 years old at enrollment
    • Primary diagnosis of brain tumor or non-CNS solid tumor
    • 6 to 12 months since therapy was completed
    • Chemotherapy was part of tumor treatment
    • Able to speak and read English
  3. SEDYC Quick View
    Sponsors St. Jude Children's Research Hospital
    ClinicalTrials.gov identifier NCT03086421
    Trial Start Date March 2017
    Estimated Enrollment 64
    Study Type Observational
    Study Phase N/A
    Conditions Solid tumor, brain tumor
    Ages 4 to 6 years old
    Principal investigator Victoria Willard, PhD
    Study Sites St. Jude Children's Research Hospital 
    For a consultation or to discuss SEDYC St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.