Back to resultsFeasibility Neurocognitive Outcome After Transplant
Primary Purpose
Stem Cell Transplantation, Pediatric Cancer, Acute Lymphoblastic Leukemia
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive rehabilitation program
Sponsored by
About this trial
This is an interventional supportive care trial for Stem Cell Transplantation
Eligibility 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.
Sites / Locations
- Stanford University, School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive rehabilitation arm
Arm Description
Cognitive rehabilitation program
Outcomes
Primary Outcome Measures
Number of participants who complete the post-transplant neurocognitive intervention program
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02300961
Brief Title
Feasibility Neurocognitive Outcome After Transplant
Official Title
A Risk Stratification Model for Neurocognitive Outcome After Transplant and Feasibility of an Early Cognitive Intervention Program
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Business decision
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplantation, Pediatric Cancer, Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive rehabilitation arm
Arm Type
Experimental
Arm Description
Cognitive rehabilitation program
Intervention Type
Behavioral
Intervention Name(s)
Cognitive rehabilitation program
Primary Outcome Measure Information:
Title
Number of participants who complete the post-transplant neurocognitive intervention program
Time Frame
26 weeks after transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Hiniker
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility Neurocognitive Outcome After Transplant
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