Feasibility Neurocognitive Outcome After Transplant

Stanford University17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Stem Cell Transplantation Pediatric Cancer Acute Lymphoblastic Leukemia

Interventions

Cognitive rehabilitation programBEHAVIORAL

Eligibility

Sex: ALLMin age: 6 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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: * 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.

Locations (1)

Stanford University, School of Medicine

Palo Alto, California, United States

Outcomes

Primary Outcomes

Number of participants who complete the post-transplant neurocognitive intervention program

Number of participants who enroll in and are able to complete the neurocognitive intervention program, measured at 3 months after enrollment.

Time frame: 3 months after enrollment

Secondary Outcomes

Number of participants who complete at least half of the neurocognitive intervention program

Number of participants who complete at least 50% of scheduled sessions in the neurocognitive intervention program.

Time frame: 3 months after enrollment

Change in WISC-IV or WAIS-IV scores

Change in intellectual functioning scores (Full Scale IQ, Verbal Comprehension, Perceptual Reasoning, Working Memory, and Processing Speed indices) from pre-treatment to 1 and 2 years post-treatment.

Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

Change in WRAML-2 scores

Change in verbal and visual memory scores from pre-treatment to 1 and 2 years post-treatment using the Wide Range Assessment of Memory and Learning, Second Edition (WRAML-2).

Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

Change in executive functioning scores (D-KEFS or NEPSY-II)

Change in executive functioning scores from pre-treatment to 1 and 2 years post-treatment, using Delis Kaplan Executive Function System (D-KEFS; ages 8-21) or NEPSY-II subtests (ages 6-7).

Time frame: Baseline, 1 year post-treatment, 2 years post-treatment

Change in CPT-II scores

Change in sustained attention/vigilance scores from pre-treatment to 1 and 2 years post-treatment using Conners' Continuous Performance Test, Second Edition (CPT-II).

Data from ClinicalTrials.gov

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