LeukemiaNCT00498719
Cognitive Training in Attenuating Attention Deficits/Child Treatment for Cancer
An observational study of Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Leukemia, Lymphoma, Brain Tumor
- What is being tested?
- Cognitive Training Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants with leukemia, lymphoma, or brain tumor that are at least 6 years old.
Who may be able to join
- Eligibility criteria to participate in the study are: at least 6-years-old.
- Enrolled in school or homebound instruction in a grade Kindergarten through 12th.
- A diagnosis of leukemia, lymphoma, or brain tumor (e.g., primary brain tumors, leptomeningeal infiltration, or metastases) that requires treatment of the CNS (surgery, CRT, and/or chemotherapy).
- Within 2 months to 14 months after beginning treatment for cancer.
- Full scale IQ > or = 70.
- English-speaking. (This is defined as the ability to appropriately respond to test and training materials.)
Who cannot join
- 1) A major physical, neurologic, or psychiatric condition that would preclude participation in the research program. The functional criteria for exclusion is inability to perceive and comprehend training materials and therapeutic interventions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study of the Effectiveness of Cognitive Training in Preventing Attention Deficits Among Children in Treatment for Cancer
Primary Objectives:
- 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.
- 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.
- To explore the relationship between CTP treatment compliance and stability/decline 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 patient's performance on neurocognitive measures.
Read the 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 child's attention processes. The CTP includes instructions on how to improve the way your child's mind approaches a task, how he/she performs different tasks, and what he/she 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, he/she 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 child's comfort. After each test session, you and your child will talk to a member of the study staff about your child's results and what they mean to your child's 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 him/her take a short rest break.
The therapy program your child receives will be especially designed for him/her, building on his/her strengths as well as focusing on areas where he/she 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.
- Conditions
- Leukemia, Lymphoma, Brain Tumor
- Being tested
- Cognitive Training Program, Control Group
- Keywords
- Leukemia, Lymphoma, Brain Tumor, Attention Deficit, Cognitive Training Program, Central Nervous System, CNS, CTP
- Medical subject headings
- Leukemia, Lymphoma, Brain Neoplasms, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Training ProgramBehavioural
Also called CTP
Cognitive training sessions over a 4 to 6 month training period, each lasting about 2 hours.
Control GroupOther
Standard educational support.
| Study group | Role | What they receive |
|---|---|---|
| CTP Group | One-on-one cognitive training Receives: Behavioral: Cognitive Training Program | |
| Control Group | Standard educational support. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Academic + Cognitive Decline Pre- to Post-Treatment
Determine whether Cognitive Training Program (CTP) prevents declines in cognitive and academic skills by comparing change from pre- to post-treatment through Academic achievement tests and psychological adjustment questionnaires at three points of time (baseline, at the end of training and 6 months later)
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startApr 2004
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Askins, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498719
- Sponsor's protocol ID
- 2004-0126
- Status last verified
- Dec 2020
- First submitted
- 9 Jul 2007
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of Cognitive Training in Preventing Attention Deficits Among Children in Treatment for Cancer
- ClinicalTrials.gov ID
- NCT00498719
- Acronym / sponsor ID
- 2004-0126
- Conditions
- Leukemia, Lymphoma, Brain Tumor
- Keywords
- Leukemia, Lymphoma, Brain Tumor, Attention Deficit, Cognitive Training Program, Central Nervous System, CNS, CTP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2004 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- 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.
- 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.
- To explore the relationship between CTP treatment compliance and stability/decline 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 patient's 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 child's attention processes. The CTP includes instructions on how to improve the way your child's mind approaches a task, how he/she performs different tasks, and what he/she 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, he/she 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 child's comfort. After each test session, you and your child will talk to a member of the study staff about your child's results and what they mean to your child's 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 him/her take a short rest break.
The therapy program your child receives will be especially designed for him/her, building on his/her strengths as well as focusing on areas where he/she 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTP Group | – | Behavioral: Cognitive Training ProgramOne-on-one cognitive training |
| Control Group | – | Other: Control GroupStandard educational support. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants with leukemia, lymphoma, or brain tumor that are at least 6 years old.
Key inclusion criteria (6 listed)
- Eligibility criteria to participate in the study are: at least 6-years-old.
- Enrolled in school or homebound instruction in a grade Kindergarten through 12th.
- A diagnosis of leukemia, lymphoma, or brain tumor (e.g., primary brain tumors, leptomeningeal infiltration, or metastases) that requires treatment of the CNS (surgery, CRT, and/or chemotherapy).
- Within 2 months to 14 months after beginning treatment for cancer.
- Full scale IQ > or = 70.
Key exclusion criteria (1 listed)
- 1) A major physical, neurologic, or psychiatric condition that would preclude participation in the research program. The functional criteria for exclusion is inability to perceive and comprehend training materials and therapeutic interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Training ProgramAlso: CTPCognitive training sessions over a 4 to 6 month training period, each lasting about 2 hours. | Behavioural | CTP Group |
| Control GroupStandard educational support. | Other | Control Group |
Primary outcome
Number of Participants with Academic + Cognitive Decline Pre- to Post-Treatment
Time frame: 5 Years
Determine whether Cognitive Training Program (CTP) prevents declines in cognitive and academic skills by comparing change from pre- to post-treatment through Academic achievement tests and psychological adjustment questionnaires at three points of time (baseline, at the end of training and 6 months later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Askins, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Academic + Cognitive Decline Pre- to Post-Treatment (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.