Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Leukemia |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/13/2018 |
| Start Date: | August 18, 2016 |
| End Date: | August 2019 |
| Contact: | Lisa M. Jacola, PhD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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.
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.
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.
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.
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
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Lisa M. Jacola, PhD
Phone: 866-278-5833
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