Social Emotional Development in Young Children With Cancer

St. Jude Children's Research Hospital

Status: Active, not recruiting

Conditions: Solid Tumor, Childhood; Brain Tumor, Pediatric

Treatments: Behavioral: Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT03086421

NCI-2021-05585 (Registry Identifier)

SEDYC

Details and patient eligibility

About

Many children with cancer are diagnosed in early childhood, and as such, will likely miss key social experiences such as participation in preschool or kindergarten, playing on playgrounds, and other normative experiences. In typically-developing children, it is known that these experiences - and the skills that are learned during them - are critical to later well-being. Very little is known about the psychological functioning of young children with cancer, as studies have predominantly focused on those who are older (at least 8 years of age). This study will explicitly assess social functioning in preschool-aged children with cancer and follow the development of their social functioning from the end of treatment into survivorship.

The goals of this pilot study are to begin to assess the impact of missed early childhood social experiences, as well as the interaction with developing neurocognitive problems.

PRIMARY OBJECTIVE: Explore the impact of cancer in the central nervous system on social functioning of young children (ages 4-6) after completion of therapy.

Full description

Participants will be evaluated using the same or similar questionnaires at two time points. The first assessment will take place when they are 6-12 months post the end of treatment. Participants and their parents/legal guardian will complete an assessment of social and cognitive functioning by completing questionnaires about social, emotional, behavioral, and executive functioning. If the study participant agrees, they will identify another adult (that is, teacher or daycare employee) who may be contacted to complete questionnaires about the participant's social and behavioral functioning. A follow-up study visit will occur about two years later.

Enrollment: 119 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Diagnosis of a brain or non-CNS solid tumor
• Between 4 and 6 years of age at enrollment
• Between 6 and 12 months post-therapy at the time of enrollment
• Treatment plan included chemotherapy
• English speaking
• Cognitive and language capacity to complete measures

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)
• Solid tumor patients who required CNS-directed therapy (e.g., radiation, intrathecal chemotherapy)
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Trial design

119 participants in 2 patient groups

Brain Tumor Participants

Description:

Participants with a diagnosis of brain tumor who are between the ages of 4 and 6 years old and are 6 to 12 months post-completion of treatment. They will complete several standard questionnaires.

Treatment:

Behavioral: Questionnaires

Solid Tumor Participants

Description:

Participants with a diagnosis of non-Central Nervous System (non-CNS) solid tumor who are between the ages of 4 and 6 years old and are 6 to 12 months post-completion of treatment. They will complete several standard questionnaires.

Treatment:

Behavioral: Questionnaires