SEDYC: Social and Emotional Development in Children with Cancer

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 (+/- 1 month) (Recently off-therapy strata) 
• More than 18 months post-therapy (Survivor strata)
• Chemotherapy was part of tumor treatment
• Able to speak and read English

Exclusion Criteria include:

• 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

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 (+/- 1 month) OR more than 18 months since therapy was completed
• Chemotherapy was part of tumor treatment
• Able to speak and read English