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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive Outcome	Descriptive statistics will be estimated.	Once at participant enrollment
Psychosocial Outcome	Descriptive statistics will be estimated.	Once at participant enrollment

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Lisa M. Jacola, 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): August 18, 2016
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Attention; Leukemia; Down Syndrome; Neurocognitive; Survivorship; Executive function; Late effects
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Leukemia; Down Syndrome
• Other Study ID Numbers: DSCOG

Drug and device information, study documents

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