Feasibility Neurocognitive Outcome After Transplant

NCT ID: NCT02300961

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-01

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Stem Cell Transplantation Pediatric Cancer Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cognitive rehabilitation arm

Cognitive rehabilitation program

Group Type EXPERIMENTAL

Cognitive rehabilitation program

Intervention Type BEHAVIORAL

Interventions

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Cognitive rehabilitation program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Hiniker, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University, School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2014-02434

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-31680

Identifier Type: -

Identifier Source: org_study_id

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