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Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome

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ClinicalTrials.gov Identifier: NCT02859389
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:

Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits, reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive assessment is frequently implemented during therapy and continued into survivorship to monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at 10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are comparable to or lower than patients without DS, however, these patients are at greater risk for treatment-related toxicities. Children with preexisting neurodevelopmental conditions, including DS, are systematically excluded from neurocognitive assessment on clinical trials, contributing to a gap in the investigators understanding of outcomes in these patients with preexisting neurocognitive vulnerability. The investigators propose a novel preliminary investigation of functional outcomes in children with DS and childhood leukemia. This study has implications for future treatment of leukemia patients with DS, and may generalize to leukemia patients with other predispositions or preexisting neurodevelopmental conditions (e.g., genetic disorders, acquired brain injury, autism, and epilepsy).

Primary Objective:

  • To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia with Down Syndrome using a novel assessment approach.

Condition or disease
Leukemia Down Syndrome

Detailed Description:
The investigators will recruit survivors of childhood leukemia with DS to participate in a one-time assessment of neurocognitive and psychosocial functioning. Potentially eligible families will be identified via medical record review at St. Jude Children's Research Hospital (SJCRH) and contacted to discuss study objectives, assess interest, and confirm eligibility. Eligible families will be scheduled for one study visit, estimated to last about 2.5 hours. Participants will provide informed consent prior to the start of any study procedures. Survivors who are ≥ 5 years old will complete performance-based neurocognitive measures. Caregivers (i.e., parents or legal guardians) of all participants, regardless of age, will complete ratings of executive function, behavior, and adaptive skills. Participants will be asked to identify and provide written permission to contact a secondary informant (e.g., teacher or work supervisor). Identified informants will be contacted by study team members and asked to complete behavior rating scales.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome
Actual Study Start Date : August 18, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Neurocognitive Outcome [ Time Frame: Once at participant enrollment ]
    Descriptive statistics will be estimated.

  2. Psychosocial Outcome [ Time Frame: Once at participant enrollment ]
    Descriptive statistics will be estimated.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will have Down Syndrome and will have been treated for childhood leukemia at St. Jude Children's Research Hospital (SJCRH).
Criteria

Inclusion Criteria:

  • Patient is an SJCRH patient with a diagnosis of leukemia.
  • Diagnosis of Trisomy 21 DS as documented in the medical record
  • Completed all cancer-directed therapy at SJCRH, since 1980, and at least 6 months prior to the study visit
  • English as the primary language

Exclusion Criteria:

  • Documented history of central nervous system (CNS) injury or disease that occurred after completing cancer-directed therapy
  • History of or current substance use or abuse

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): NCT02859389


Contacts
Contact: Lisa M. Jacola, PhD 866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Lisa M. Jacola, PhD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Lisa M. Jacola, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Lisa M. Jacola, PhD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02859389     History of Changes
Other Study ID Numbers: DSCOG
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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:
Leukemia
Down Syndrome
Neurocognitive
Survivorship
Attention
Executive function
Late effects

Additional relevant MeSH terms:
Intellectual Disability
Syndrome
Leukemia
Down Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn