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 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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Childhood; Brain Tumor, Pediatric
• Intervention / Treatment: Behavioral: Questionnaires

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.

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Victoria W. Willard, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Victoria W. Willard, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
      • Principal Investigator: Victoria W. Willard, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brain Tumor Participants; 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.	Behavioral: Questionnaires; Participants, their parent/legal guardian, and if consented to another adult caregiver will be asked to complete several questionnaires evaluating the participant's social cognitive skills, social experience, neurocognitive functioning, and neurocognitive skills.; Other Names: Psychological Evaluation; Standardized Testing
Solid Tumor Participants; 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.	Behavioral: Questionnaires; Participants, their parent/legal guardian, and if consented to another adult caregiver will be asked to complete several questionnaires evaluating the participant's social cognitive skills, social experience, neurocognitive functioning, and neurocognitive skills.; Other Names: Psychological Evaluation; Standardized Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social functioning as assessed by parent-completed measures and child-completed measures	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 solid tumor).	All measures will be completed at both the study enrollment and 24±3 months later

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Victoria W. Willard, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Childhood cancer; Social development; Social functioning
• Other Study ID Numbers: SEDYC; NCI-2021-05585 (Registry Identifier: NCI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No