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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Emotional Development in Young Children With Cancer
- ClinicalTrials.gov ID
- NCT03086421
- Acronym / sponsor ID
- SEDYC
- Conditions
- Solid Tumor, Childhood, Brain Tumor, Pediatric
- Keywords
- Childhood cancer, Social functioning, Social development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Tumor Participants | – | Behavioral: QuestionnairesParticipants 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. |
| Solid Tumor Participants | – | Behavioral: QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: Psychological Evaluation, Standardized TestingParticipants, 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. | Behavioural | Brain Tumor Participants, Solid Tumor Participants |
Primary outcome
Social functioning as assessed by parent-completed measures and child-completed measures
Time frame: All measures will be completed at both the study enrollment and 24±3 months later
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Conklin, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social functioning as assessed by parent-completed measures and child-completed measures (time frame: All measures will be completed at both the study enrollment and 24±3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.