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Feasibility Neurocognitive Outcome After Transplant

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ClinicalTrials.gov Identifier: NCT02300961
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stem Cell Transplantation Pediatric Cancer Acute Lymphoblastic Leukemia Behavioral: Cognitive rehabilitation program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program
Study Start Date : December 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Cognitive rehabilitation arm
Cognitive rehabilitation program
Behavioral: Cognitive rehabilitation program



Primary Outcome Measures :
  1. Number of participants who complete the post-transplant neurocognitive intervention program [ Time Frame: 26 weeks after transplant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300961


Contacts
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Contact: Susan Hiniker shiniker@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Susan Hiniker       shiniker@stanford.edu   
Principal Investigator: Susan Hiniker         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Susan Hiniker Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02300961     History of Changes
Other Study ID Numbers: IRB-31680
PEDSHEM0004 ( Other Identifier: OnCore )
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases