Acute Lymphoblastic Leukemia, Pediatric Cancer, Stem Cell Transplantation
Conditions
Brief summary
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.
Interventions
BEHAVIORALCognitive rehabilitation program
Sponsors
Stanford University
Thrasher Research Fund
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete the post-transplant neurocognitive intervention program | 3 months after enrollment | Number of participants who enroll in and are able to complete the neurocognitive intervention program, measured at 3 months after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete at least half of the neurocognitive intervention program | 3 months after enrollment | Number of participants who complete at least 50% of scheduled sessions in the neurocognitive intervention program. |
| Change in WISC-IV or WAIS-IV scores | Baseline, 1 year post-treatment, 2 years post-treatment | 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. |
| Change in WRAML-2 scores | Baseline, 1 year post-treatment, 2 years post-treatment | 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). |
| Change in executive functioning scores (D-KEFS or NEPSY-II) | Baseline, 1 year post-treatment, 2 years post-treatment | 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). |
| Change in CPT-II scores | Baseline, 1 year post-treatment, 2 years post-treatment | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Hiniker, MD
Stanford University
Outcome results
None listed