Feasibility Neurocognitive Outcome After Transplant

Not Applicable

Recruiting

• Conditions: Stem Cell Transplantation; Pediatric Cancer; Acute Lymphoblastic Leukemia
• Interventions: Behavioral: Cognitive rehabilitation program

• Registration Number: NCT02300961
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Study Start: 2014-12-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15
• Primary Completion: 2026-05
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive rehabilitation arm	Cognitive rehabilitation program	Cognitive rehabilitation program

Primary Outcome Measures

Name	Time	Method
Number of participants who complete the post-transplant neurocognitive intervention program	26 weeks after transplant

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States