Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498719
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2020-12-31
First Post:
2007-07-09
Brief Title:
Cognitive Training in Attenuating Attention DeficitsChild Treatment for Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study of the Effectiveness of Cognitive Training in Preventing Attention Deficits Among Children in Treatment for Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1 To evaluate the feasibility of enrolling children and adolescents with newly diagnosed brain tumors leukemia or lymphoma in a program designed to prevent the academic and cognitive declines that commonly result following central nervous system CNS disease and treatment
Hypothesis 1 Despite the rigors of disease and treatment children and adolescents will be able to participate in the CTP while they are receiving treatment for cancer The high participation of our patients in routine school activities during treatment suggests that they will have the energy and interest required to participate in cognitive training
2 To evaluate whether a Cognitive Training Program CTP might be helpful to patients in preventing attention deficits that commonly result following CNS disease and therapy
Hypothesis 2 Patients in the CTP arm of the study will show fewer declines in neurocognitive performance at the end of training and again six months later as compared with the control group who will receive the usual services provided by the Education Program in Pediatrics
3 To explore the relationship between CTP treatment compliance and stabilitydecline in cognitive and academic performance in children and adolescents who are being treated for brain tumors leukemia and lymphoma
Hypothesis 3 Level of compliance with CTP treatment will be predictive of a patients performance on neurocognitive measures
1 To evaluate the feasibility of enrolling children and adolescents with newly diagnosed brain tumors leukemia or lymphoma in a program designed to prevent the academic and cognitive declines that commonly result following central nervous system CNS disease and treatment
Hypothesis 1 Despite the rigors of disease and treatment children and adolescents will be able to participate in the CTP while they are receiving treatment for cancer The high participation of our patients in routine school activities during treatment suggests that they will have the energy and interest required to participate in cognitive training
2 To evaluate whether a Cognitive Training Program CTP might be helpful to patients in preventing attention deficits that commonly result following CNS disease and therapy
Hypothesis 2 Patients in the CTP arm of the study will show fewer declines in neurocognitive performance at the end of training and again six months later as compared with the control group who will receive the usual services provided by the Education Program in Pediatrics
3 To explore the relationship between CTP treatment compliance and stabilitydecline in cognitive and academic performance in children and adolescents who are being treated for brain tumors leukemia and lymphoma
Hypothesis 3 Level of compliance with CTP treatment will be predictive of a patients performance on neurocognitive measures
Detailed Description:
The Cognitive Training Program CTP is made up of many elements It includes procedures that are designed to build five types of attention skills as well as motivational activities that exercise your childs attention processes The CTP includes instructions on how to improve the way your childs mind approaches a task how heshe performs different tasks and what heshe does after finishing tasks The CTP also includes the use of therapy to improve and maintain motivation self-esteem and self-confidence as well as to help your child stay motivated and keep from getting distracted
Before your child can take part in this study heshe will have what is called a screening test of intelligence This test will help the doctor decide if your child is eligible to take part in the study In order for a child to participate in the study he or she has to achieve a score 70 on the screening test at least within the borderline range of intelligence because this level of intelligence is necessary for a child to understand the CPT educational materials It is possible that after this test your child may not be able to continue on this study The screening test results will be discussed with you
Your child will be randomly assigned as in the toss of a coin to either the CTP or a control group The control group will receive standard educational support but will not receive the one-on-one cognitive training given during the study After the study is completed patients randomized to the control group will be eligible to receive the CTP intervention free of charge if the parents prefer All participants will complete standardized cognitive and academic tests at three time points at the beginning of the study six months later and then six months after that The tests will be given by a very experienced research assistant who will ask your child questions and have him or her complete various paper and pencil tasks or puzzles Testing at each of the three time points will take about 3 hours However the test sessions can be divided into shorter sessions if necessary for the childs comfort After each test session you and your child will talk to a member of the study staff about your childs results and what they mean to your childs progress
Your child will be seen for a total of 20 study-therapy visits as long as they are in the intervention group over a 4 to 6 month training period Each visit will be about two hours long and will occur once a week during the training period The study visits will be one-on-one sessions between your child and the therapist Each study visit will be include two 50-minute training sessions with a 15-minute break between them During training sessions your child will participate in several activities Each activity will only last about 15 minutes each If your child gets tired during a session the therapist will let himher take a short rest break
The therapy program your child receives will be especially designed for himher building on hisher strengths as well as focusing on areas where heshe needs more help
This is an investigational study CTP and assessment appointments will be scheduled on days that your child is already in the clinic or inpatient as often as possible About 30 children will take part in this study All will be enrolled at M D Anderson
Before your child can take part in this study heshe will have what is called a screening test of intelligence This test will help the doctor decide if your child is eligible to take part in the study In order for a child to participate in the study he or she has to achieve a score 70 on the screening test at least within the borderline range of intelligence because this level of intelligence is necessary for a child to understand the CPT educational materials It is possible that after this test your child may not be able to continue on this study The screening test results will be discussed with you
Your child will be randomly assigned as in the toss of a coin to either the CTP or a control group The control group will receive standard educational support but will not receive the one-on-one cognitive training given during the study After the study is completed patients randomized to the control group will be eligible to receive the CTP intervention free of charge if the parents prefer All participants will complete standardized cognitive and academic tests at three time points at the beginning of the study six months later and then six months after that The tests will be given by a very experienced research assistant who will ask your child questions and have him or her complete various paper and pencil tasks or puzzles Testing at each of the three time points will take about 3 hours However the test sessions can be divided into shorter sessions if necessary for the childs comfort After each test session you and your child will talk to a member of the study staff about your childs results and what they mean to your childs progress
Your child will be seen for a total of 20 study-therapy visits as long as they are in the intervention group over a 4 to 6 month training period Each visit will be about two hours long and will occur once a week during the training period The study visits will be one-on-one sessions between your child and the therapist Each study visit will be include two 50-minute training sessions with a 15-minute break between them During training sessions your child will participate in several activities Each activity will only last about 15 minutes each If your child gets tired during a session the therapist will let himher take a short rest break
The therapy program your child receives will be especially designed for himher building on hisher strengths as well as focusing on areas where heshe needs more help
This is an investigational study CTP and assessment appointments will be scheduled on days that your child is already in the clinic or inpatient as often as possible About 30 children will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None