Feasibility Neurocognitive Outcome After Transplant

NCT02300961 | Completed

• 2 other identifiers: IRB-31680NCI-2014-02434
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation; Pediatric Cancer; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after enrollment

Secondary Outcomes (5)

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

  3 months after enrollment

• Change in WISC-IV or WAIS-IV scores

  Baseline, 1 year post-treatment, 2 years post-treatment

• Change in WRAML-2 scores

  Baseline, 1 year post-treatment, 2 years post-treatment

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

  Baseline, 1 year post-treatment, 2 years post-treatment

• Change in CPT-II scores

  Baseline, 1 year post-treatment, 2 years post-treatment

Study Arms (1)

Cognitive rehabilitation arm

EXPERIMENTAL

Cognitive rehabilitation program

Behavioral: Cognitive rehabilitation program

Interventions

Cognitive rehabilitation program BEHAVIORAL

Cognitive rehabilitation arm

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Susan Hiniker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: February 3, 2024
• Study Completion: February 3, 2024
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)