Acute Lymphoblastic LeukemiaNCT00945828
Assessing the Effectiveness of Individual Education Plans for Childhood Cancer Survivors
A study testing Annual Intervention Group and Quarterly Monitoring of IEP in people with Acute Lymphoblastic Leukemia and Central Nervous System Tumors, run by University of Miami at 1 site in United States.
Trial summary
Neurodevelopmental outcomes in children treated for cancer involving the central nervous system (CNS) provide educators with new challenges with regards to classification, monitoring, and intervention in the regular or special education classroom setting. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Central Nervous System Tumors, Lymphoma
- What is being tested?
- Annual Intervention Group and Quarterly Monitoring of IEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Oct 2010
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children, ages 6-12 years, who are within 2-5 years of diagnosis for either central nervous system tumor or acute lymphocytic leukemia, or lymphoma at time of enrollment
Who cannot join
- Children who have been diagnosed with any type of cancer other than a central nervous system tumor, lymphoma, or leukemia.
- Children who are not between the ages of 6-12 years and who were not diagnosed within the past 2-5 years with central nervous system tumor, lymphoma, or leukemia.
- Children who are monolingual in a language other than English or Spanish
- Parent or caregiver of the child is not fluent in English or Spanish
- Child has been diagnosed with a significant mental health disorder that is not responsive to behavioral or medical management. This includes severe depression, schizophrenia, or bipolar disorder. Children whose mental health problem is effectively treated are eligible for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mailman Center for Child Development University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Assessing Implementation and Effectiveness of Individual Education Plans for Children With Chronic Illness
Neurodevelopmental outcomes in children treated for cancer involving the central nervous system (CNS) provide educators with new challenges with regards to classification, monitoring, and intervention in the regular or special education classroom setting. Recommendations resulting from serial neurodevelopmental evaluations for these children often do not overlap with traditional special education recommendations commonly included in Individual Education Plans (IEPs) for children with congenital or genetic learning problems. The investigators currently do not know whether or not school-based treatment for learning problems, based on the child's IEP, incorporates recommendations made based on a neurodevelopmental evaluation appropriately. In addition, it is not clear whether or not the recommendations that are included in a child's IEP have any beneficial outcome on the child's learning and academic achievement over time. The purpose of this project is to examine the relationship between neurodevelopmental outcomes, recommendations for intervention, special education services and accommodations included in a child's school IEP, and outcome for the child following implementation of the IEP. The study has two major specific aims:
- To quantify the clinical and educational contributions of recommendations resulting from neurodevelopmental evaluations and the subsequent development of IEPs. Hypothesis 1.1: Higher concordance between recommendations made based on neurodevelopmental evaluations and criteria written into children's IEPs will be associated with more positive academic outcomes (i.e. maintenance or improvement in academic skills). Hypothesis 1.2: Children who have higher concordance between criteria written into their IEPs and academic services actually received will show more positive academic outcomes than children whose IEP criteria and academic services are less concordant.
- To evaluate an intervention that will improve academic outcomes for children treated for cancer.
Hypothesis 2.1: Children whose IEPs are monitored more frequently will show more positive academic outcomes than their peers whose IEPs are monitored less frequently.
Read the detailed description
For years, researchers have examined the effects of cancer and its treatment on children's neurodevelopment. This body of research has identified a number of specific threats to children's cognitive functioning and academic achievement, due to both acute effects and late effects of cancer and its treatment. These often translate into difficulties in the academic setting. Specifically, areas of cognitive and behavioral development are frequently affected, leading to concomitant difficulties in academic achievement and social interaction. Previous research has indicated that such developmental effects and concomitant difficulties are particularly notable in children treated for brain tumors and for leukemias with central nervous system (CNS) involvement. Neurodevelopmental assessments conducted as part of clinical evaluations serve to identify individual strengths and weaknesses of each child treated. Results of these assessments are used to formulate recommendations targeted at compensating for weaknesses by accentuating strengths of each child. Child Study Team meetings are scheduled, at the parent's request, at the child's school in order to use these recommendations in developing Individual Educational Plans (IEPs) to best meet the special needs of the student. At present, no formal follow-up procedure exists to ensure that the IEPs are implemented appropriately, nor that they are effective in meeting the identified special needs of the children.
The present study proposes to 1) evaluate the IEP implementation process for children with cancer, 2) evaluate the effectiveness of IEPs in helping to improve academic outcomes for children with cancer, and 3) to evaluate the influence on academic outcomes of a high-monitoring follow-up intervention for children with cancer. To address these objectives, school-aged children with central nervous system tumors, acute lymphoblastic leukemia, or lymphoma will be administered a neurodevelopmental assessment to measure any specific educational needs they may have. The results of the neurodevelopmental assessment are provided to the parent in a feedback session where any questions or concerns regarding the evaluation can be addressed. At the time of the feedback session, parents are informed of the IEP process and are requested to contact the school to request that a Child Study Team Meeting take place. The study personnel offer to attend the meeting with the parent. Results of the assessments will be used to help guide recommendations made for academic placement and accommodations as per the school's guidelines.
Children with cancer will be assigned to either a quarterly follow-up or annual follow-up group. For those children in the quarterly follow-up group, parents and primary teacher (the primary teacher is identified by the parent/guardian as the teacher who has the most contact with the child and/or knows the child best) will be asked to provide information at the end of each grading period (4 times/year) regarding the child's performance, progress, and adherence to the IEP developed. For children in the yearly follow-up group, this information will only be collected at the end of each academic year. Children in the quarterly and annual follow-up groups will be re-assessed annually for a total of 3 years to evaluate any changes in neurodevelopmental functioning and academic achievement.
Children in the two experimental groups will be administered a neurodevelopmental evaluation, and, in addition, will receive academic follow-up on either a quarterly or annual basis, depending upon to which group they are randomized. Enrollment is on an ongoing basis and each participant will be followed for 3 years after enrollment, receiving a neurodevelopmental evaluation each year with a final endpoint evaluation at year 4 (a total of 4 neurodevelopmental evaluations).
- Being tested
- Annual Intervention Group, Quarterly Monitoring of IEP
- Keywords
- pediatric cancer, neurocognitive outcomes for pediatric cancer, acute lymphoblastic leukemia, central nervous system tumors, lymphoma
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Central Nervous System Neoplasms, Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annual Intervention GroupBehavioural
Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP once per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed.
Quarterly Monitoring of IEPBehavioural
Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP four times per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed.
| Study group | Role | What they receive |
|---|---|---|
| Annual Monitoring of IEP | Experimental | Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP once per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. Receives: Behavioral: Annual Intervention Group |
| Quarterly Monitoring of IEP | Experimental | Parents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP four times per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. Receives: Behavioral: Quarterly Monitoring of IEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition
Measured: Measured at Year 1, Year 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJan 2003
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Maria L. Goldman, University of Miami
- Investigators
- Daniel Armstrong, PhD, Principal investigator, University of MiamiMaria L Goldman, PsyD, Study director, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945828
- Sponsor's protocol ID
- RSGPB PBP 105184
- Other IDs
- RSGPB PBP 105184
- Status last verified
- Mar 2012
- First submitted
- 22 Jul 2009
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Implementation and Effectiveness of Individual Education Plans for Children With Chronic Illness
- ClinicalTrials.gov ID
- NCT00945828
- Acronym / sponsor ID
- RSGPB PBP 105184
- Keywords
- pediatric cancer, neurocognitive outcomes for pediatric cancer, acute lymphoblastic leukemia, central nervous system tumors, lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jan 2003
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Jul 2009 (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.
Neurodevelopmental outcomes in children treated for cancer involving the central nervous system (CNS) provide educators with new challenges with regards to classification, monitoring, and intervention in the regular or special education classroom setting. Recommendations resulting from serial neurodevelopmental evaluations for these children often do not overlap with traditional special education recommendations commonly included in Individual Education Plans (IEPs) for children with congenital or genetic learning problems. The investigators currently do not know whether or not school-based treatment for learning problems, based on the child's IEP, incorporates recommendations made based on a neurodevelopmental evaluation appropriately. In addition, it is not clear whether or not the recommendations that are included in a child's IEP have any beneficial outcome on the child's learning and academic achievement over time. The purpose of this project is to examine the relationship between neurodevelopmental outcomes, recommendations for intervention, special education services and accommodations included in a child's school IEP, and outcome for the child following implementation of the IEP. The study has two major specific aims:
- To quantify the clinical and educational contributions of recommendations resulting from neurodevelopmental evaluations and the subsequent development of IEPs. Hypothesis 1.1: Higher concordance between recommendations made based on neurodevelopmental evaluations and criteria written into children's IEPs will be associated with more positive academic outcomes (i.e. maintenance or improvement in academic skills). Hypothesis 1.2: Children who have higher concordance between criteria written into their IEPs and academic services actually received will show more positive academic outcomes than children whose IEP criteria and academic services are less concordant.
- To evaluate an intervention that will improve academic outcomes for children treated for cancer.
Hypothesis 2.1: Children whose IEPs are monitored more frequently will show more positive academic outcomes than their peers whose IEPs are monitored less frequently.
Detailed description
For years, researchers have examined the effects of cancer and its treatment on children's neurodevelopment. This body of research has identified a number of specific threats to children's cognitive functioning and academic achievement, due to both acute effects and late effects of cancer and its treatment. These often translate into difficulties in the academic setting. Specifically, areas of cognitive and behavioral development are frequently affected, leading to concomitant difficulties in academic achievement and social interaction. Previous research has indicated that such developmental effects and concomitant difficulties are particularly notable in children treated for brain tumors and for leukemias with central nervous system (CNS) involvement. Neurodevelopmental assessments conducted as part of clinical evaluations serve to identify individual strengths and weaknesses of each child treated. Results of these assessments are used to formulate recommendations targeted at compensating for weaknesses by accentuating strengths of each child. Child Study Team meetings are scheduled, at the parent's request, at the child's school in order to use these recommendations in developing Individual Educational Plans (IEPs) to best meet the special needs of the student. At present, no formal follow-up procedure exists to ensure that the IEPs are implemented appropriately, nor that they are effective in meeting the identified special needs of the children.
The present study proposes to 1) evaluate the IEP implementation process for children with cancer, 2) evaluate the effectiveness of IEPs in helping to improve academic outcomes for children with cancer, and 3) to evaluate the influence on academic outcomes of a high-monitoring follow-up intervention for children with cancer. To address these objectives, school-aged children with central nervous system tumors, acute lymphoblastic leukemia, or lymphoma will be administered a neurodevelopmental assessment to measure any specific educational needs they may have. The results of the neurodevelopmental assessment are provided to the parent in a feedback session where any questions or concerns regarding the evaluation can be addressed. At the time of the feedback session, parents are informed of the IEP process and are requested to contact the school to request that a Child Study Team Meeting take place. The study personnel offer to attend the meeting with the parent. Results of the assessments will be used to help guide recommendations made for academic placement and accommodations as per the school's guidelines.
Children with cancer will be assigned to either a quarterly follow-up or annual follow-up group. For those children in the quarterly follow-up group, parents and primary teacher (the primary teacher is identified by the parent/guardian as the teacher who has the most contact with the child and/or knows the child best) will be asked to provide information at the end of each grading period (4 times/year) regarding the child's performance, progress, and adherence to the IEP developed. For children in the yearly follow-up group, this information will only be collected at the end of each academic year. Children in the quarterly and annual follow-up groups will be re-assessed annually for a total of 3 years to evaluate any changes in neurodevelopmental functioning and academic achievement.
Children in the two experimental groups will be administered a neurodevelopmental evaluation, and, in addition, will receive academic follow-up on either a quarterly or annual basis, depending upon to which group they are randomized. Enrollment is on an ongoing basis and each participant will be followed for 3 years after enrollment, receiving a neurodevelopmental evaluation each year with a final endpoint evaluation at year 4 (a total of 4 neurodevelopmental evaluations).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Annual Monitoring of IEP | Experimental | Behavioral: Annual Intervention GroupParents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP once per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. |
| Quarterly Monitoring of IEP | Experimental | Behavioral: Quarterly Monitoring of IEPParents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP four times per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children, ages 6-12 years, who are within 2-5 years of diagnosis for either central nervous system tumor or acute lymphocytic leukemia, or lymphoma at time of enrollment
Key exclusion criteria (5 listed)
- Children who have been diagnosed with any type of cancer other than a central nervous system tumor, lymphoma, or leukemia.
- Children who are not between the ages of 6-12 years and who were not diagnosed within the past 2-5 years with central nervous system tumor, lymphoma, or leukemia.
- Children who are monolingual in a language other than English or Spanish
- Parent or caregiver of the child is not fluent in English or Spanish
- Child has been diagnosed with a significant mental health disorder that is not responsive to behavioral or medical management. This includes severe depression, schizophrenia, or bipolar disorder. Children whose mental health problem is effectively treated are eligible for participation.
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 |
|---|---|---|
| Annual Intervention GroupParents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP once per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed. | Behavioural | Annual Monitoring of IEP |
| Quarterly Monitoring of IEPParents/caregivers and the teacher of participants will be asked to evaluate the effectiveness of the child's IEP four times per academic calendar year. The evaluation is done through the use of an IEP Questionnaire developed for this study. This questionnaire addresses the child's academic performance, progress, and adherence to the IEP developed. | Behavioural | Quarterly Monitoring of IEP |
Primary outcome
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition
Time frame: Measured at Year 1, Year 2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Daniel Armstrong, PhD principal investigator
University of Miami
Maria L Goldman, PsyD study director
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annual Intervention Group and Quarterly Monitoring of IEP in people with Acute Lymphoblastic Leukemia and Central Nervous System Tumors, run by University of Miami 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 8 Mar 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Academic achievement as measured by the Woodcock Johnson Tests of Achievement, Third Edition (time frame: Measured at Year 1, Year 2 and 3). 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 8 Mar 2012.