Clinical trial NCT03086421: Social Emotional Development in Young Children With Cancer
Official title: Social Emotional Development in Young Children With Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Solid Tumor, Childhood
Brain Tumor, Pediatric
Keywords: Childhood cancer
Social functioning
Social development
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-03-22
Enrollment: 119
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients at St. Jude Children's Research Hospital who meet the eligibility criteria, along with their parent/legal guardian, and another adult caregiver.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Social functioning as assessed by parent-completed measures and child-completed measures
timeFrame: All measures will be completed at both the study enrollment and 24±3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Heather Conklin, PhD
role: PRINCIPAL_INVESTIGATOR
References: