Feasibility Neurocognitive Outcome After Transplant

Trial ID or NCT#

NCT02300961

Status

recruiting iconRECRUITING

Purpose

This pilot study will primarily be evaluated by feasibility and adherence to an iPad-based neurocognitive intervention program. It will secondarily be evaluated by performance on the neurocognitive testing post-transplant and change in performance in subsequent years.

Official Title

A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program

Eligibility Criteria

Ages Eligible for Study: 6 Years to 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - All patients must have a histologic or cytological diagnosis of ALL treated with stem cell transplantation. There are no restrictions on prior therapy. - Patients must be between the ages of 6 years and 21 years of age (inclusive), but there will be no discrimination based on gender, race, creed, or ethnic background. The age limits are set at 6 years of age in order to ensure that patients will be able to participate in these specific cognitive rehabilitation tasks. ECOG/KPS will not be employed. - Patient and/or parents/guardians as appropriate must sign an informed consent, be mentally responsible, able to understand and willing to sign a written informed consent.
Exclusion Criteria:
  1. - Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial. There are no therapy restrictions or restrictions regarding the use of other Investigational Agents. - Pregnant patients will be excluded.
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Investigator(s)

Susan Hiniker
Susan Hiniker
Radiation oncologist
Associate Professor of Radiation Oncology (Radiation Therapy)
Sarah S. Donaldson, MD

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Contact

Claire Baniel

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View on ClinicalTrials.gov