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NCT03086421 · ClinicalTrials.gov registry record

Social Emotional Development in Young Children With Cancer

A clinical trial of Solid Tumor, Childhood and Brain Tumor, Pediatric, sponsored by St. Jude Children's Research Hospital.

Active
Registry status
119
Enrollment target
1
Study location

NCT03086421: Active study of Solid Tumor, Childhood and Brain Tumor, Pediatric, sponsored by St. Jude Children's Research Hospital.

NCT03086421 is a study of Solid Tumor, Childhood and Brain Tumor, Pediatric that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 119 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03086421, a study of Solid Tumor, Childhood and Brain Tumor, Pediatric, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.

ACTIVE NOT RECRUITING
Registry status
119 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Descriptive statistics will be provided. Parents will complete the Social Competence Inventory, Quality of Play Questionnaire, and the NIH Toolbox. Patients completed measures include the subtests from the NIH Toolbox, Challenging Situations Task, and Developmental Neuropsychological Assessment (2nd edition). Analyses will be completed to assess performance on these measures at each time point and to assess change over time. Analyses will be completed by diagnostic group (brain tumor versus soli

Interventions

  • BEHAVIORAL Questionnaires

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2017-07-11
Est. Completion 2028-06

What the registry record for NCT03086421 still lists

NCT03086421 is an observational study that tracks outcomes without assigning an intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap.

The record links to 2 conditions, with Solid Tumor, Childhood appearing as the primary indexed condition, and to 1 intervention - of which Questionnaires is the first listed.

NCT03086421 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT03086421 about?

NCT03086421 is a clinical study titled "Social Emotional Development in Young Children With Cancer". 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...

What is the current status of trial NCT03086421?

This trial is currently active not recruiting. The enrollment target is 119 participants. The study started on 2017-07-11. Estimated completion is 2028-06.

What conditions does trial NCT03086421 study?

This clinical trial studies the following conditions: Solid Tumor, Childhood, Brain Tumor, Pediatric.

What interventions are being tested in trial NCT03086421?

The interventions under investigation include: Questionnaires (BEHAVIORAL).

Who is sponsoring clinical trial NCT03086421?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03086421 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03086421, the US trial registry maintained by the National Library of Medicine. NCT03086421 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.