Solid Tumor, ChildhoodNCT03086421
Social Emotional Development in Young Children With Cancer
An observational study of Solid Tumor, Childhood and Brain Tumor, Pediatric, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Solid Tumor, Childhood, Brain Tumor, Pediatric
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Solid Tumor, Childhood, Brain Tumor, Pediatric
- Being tested
- Questionnaires
- Keywords
- Childhood cancer, Social functioning, Social development
- Medical subject headings
- Brain Neoplasms, Neoplasms, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Psychological Evaluation, Standardized Testing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaires | |
| 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. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: All measures will be completed at both the study enrollment and 24±3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start11 Jul 2017
- Primary completionDec 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, ChildhoodStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Heather Conklin, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086421
- Sponsor's protocol ID
- SEDYC
- Other IDs
- NCI-2021-05585
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2017
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No