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Feasibility Neurocognitive Outcome After Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02300961
Recruitment Status : Suspended (Covid-19)
First Posted : November 25, 2014
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE November 21, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date September 28, 2020
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
Number of participants who complete the post-transplant neurocognitive intervention program [ Time Frame: 26 weeks after transplant ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Neurocognitive Outcome After Transplant
Official Title  ICMJE A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Stem Cell Transplantation
  • Pediatric Cancer
  • Acute Lymphoblastic Leukemia
Intervention  ICMJE Behavioral: Cognitive rehabilitation program
Study Arms  ICMJE Experimental: Cognitive rehabilitation arm
Cognitive rehabilitation program
Intervention: Behavioral: Cognitive rehabilitation program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 21, 2014)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300961
Other Study ID Numbers  ICMJE IRB-31680
PEDSHEM0004 ( Other Identifier: OnCore )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan Hiniker Stanford University
PRS Account Stanford University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP