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Social Emotional Development in Young Children With Cancer

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ClinicalTrials.gov Identifier: NCT03086421
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.


Condition or disease Intervention/treatment
Solid Tumor, Childhood Brain Tumor, Pediatric 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.

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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Social Emotional Development in Young Children With Cancer
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

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




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086421


Contacts
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Contact: Victoria W. Willard, PhD 866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Victoria W. Willard, PhD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Victoria W. Willard, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
American Cancer Society, Inc.
Investigators
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Principal Investigator: Victoria W. Willard, PhD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03086421     History of Changes
Other Study ID Numbers: SEDYC
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Childhood cancer
Social functioning
Social development