Trial · NCT00576472
Learning Impairments Among Survivors of Childhood Cancer
NCT00576472, Phase 4, Completed, St. Jude Children's Research Hospital; results first posted 2012-04-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Learning Impairments Among Survivors of Childhood Cancer. Trials, record NCT00576472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00576472
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Learning Impairments Among Survivors of Childhood Cancer
- NCT number
- NCT00576472
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 469 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Acute Lymphoblastic Leukemia, Brain Tumors
- Interventions
- Methylphenidate
- First posted
- 2007-12-19
- Last updated
- 2017-05-30
- Results first posted
- 2012-04-16
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brain White Matter Volume for Patients Versus Sibling Controls | Enrollment to evaluation of MRI, on average 12.8 months. | To compare the white matter volume of patients with those of sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study. |
| Primary | Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors | Enrollment to evaluation of MRI, on average 12.8 months. | To compare the white matter volume of Acute Lymphoblastic Leukemia (ALL) patients with those of patients with malignant brain tumors using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study. |
| Primary | Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls | Enrollment to evaluation of MRI, on average 12.8 months. | To compare the white matter volume of patients by treatment intensity groups (mild, moderate, and high) and sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study. |
| Primary | Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score) | From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months. | The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Methylphenidate (MPH) Home Maintenance Phase(baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months. |
| Primary | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score) | From beginning and at completion of home maintenance phase, on average 16.3 months. | The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months |
| Primary | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) | From beginning and at completion of home maintenance phase, on average 16.3 months. | The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months. |
| Primary | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score) | From beginning and at completion of home maintenance phase, on average 16.3 months. | The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months |
| Primary | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P) | From beginning and at completion of home maintenance phase, on average 16.3 months. | The Social Skills Rating System- Parent Version (SSRS-P) is a parent rating scale of social behaviors in reference to typically developing children. Thirty eight questions are rated 0 (Never) to 3 (very often). The social skills score is norm-referenced with a mean of 100±15 where a higher score is indicative of better skills. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months |
| Primary | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score | From beginning and at completion of home maintenance phase, on average 16.3 months. | The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Reading Composite consists of Basic Reading (single word reading) and Reading Comprehension. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months |
| Primary | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score | From beginning and after completion of home maintenance phase, on average 16.3 months. | The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Spelling score assesses the child's ability to spell words to dictation. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Brain White Matter Volume for Patients Versus Sibling Controls | Enrollment to evaluation of MRI, on average 12.8 months. | Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had evaluable MRI images. | percentage | MEAN |
| PRIMARY | Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors | Enrollment to evaluation of MRI, on average 12.8 months. | Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. | percentage | MEAN |
| PRIMARY | Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls | Enrollment to evaluation of MRI, on average 12.8 months. | Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had an evaluable MRI image. | percentage | MEAN |
| PRIMARY | Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score) | From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months. | 118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screen at completion. 47 patients were analyzed. | T-score | MEAN |
| PRIMARY | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score) | From beginning and at completion of home maintenance phase, on average 16.3 months. | 118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screened at completion. 47 patients were analyzed. | T-score | MEAN |
| PRIMARY | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) | From beginning and at completion of home maintenance phase, on average 16.3 months. | 118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Score Questionnaire and 68 were screen at completion. 68 patients were analyzed. | T-score | MEAN |
| PRIMARY | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score) | From beginning and at completion of home maintenance phase, on average 16.3 months. | 118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Score Questionnaire and 68 were screened at completion. 68 patients were analyzed. | T-score | MEAN |
| PRIMARY | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P) | From beginning and at completion of home maintenance phase, on average 16.3 months. | 118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System (SSRS-P) and 68 were screened at completion. 68 patients were analyzed. | T-score | MEAN |
| PRIMARY | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score | From beginning and at completion of home maintenance phase, on average 16.3 months. | 118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) REading: Composite Standard Score questionnaire and 68 were screened at completion. 68 patients were analyzed. | T-score | MEAN |
| PRIMARY | Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score | From beginning and after completion of home maintenance phase, on average 16.3 months. | 118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score System and 68 were screened at completion. 68 patients were analyzed. | T-score | MEAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Brain White Matter Volume for Patients Versus Sibling Controls | Patients | 27 | 95% Confidence Interval 26.5 to 27.5 | percentage | |
| Brain White Matter Volume for Patients Versus Sibling Controls | Siblings | 30.3 | 95% Confidence Interval 29.6 to 31 | percentage | |
| Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors | Patients With ALL | 28.4 | 95% Confidence Interval 27.6 to 29.1 | percentage | |
| Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors | Patients With Brain Tumors | 25.5 | 95% Confidence Interval 25 to 26 | percentage | |
| Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls | Siblings | 30.3 | 95% Confidence Interval 29.6 to 31 | percentage | |
| Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls | Mild Treatment Intensity | 28.8 | 95% Confidence Interval 28 to 29.7 | percentage | |
| Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls | Moderate Treatment Intensity | 25.9 | 95% Confidence Interval 24.3 to 27.5 | percentage | |
| Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls | High Treatment Intensity | 25.4 | 95% Confidence Interval 24.9 to 25.9 | percentage | |
| Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score) | Overall | -7.17 | 95% Confidence Interval -11.0 to -3.3 | T-score | |
| Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score) | Overall | -3.34 | 95% Confidence Interval -6.5 to -0.1 | T-score |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow180
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Screening | STARTED | Mild Intensity | 230 | |
| Initial Screening | STARTED | Moderate Intensity | 40 | |
| Initial Screening | STARTED | High Intensity | 199 | |
| Initial Screening | STARTED | Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase | 0 | |
| Initial Screening | STARTED | Group M/P | 0 | |
| Initial Screening | STARTED | Group P/M | 0 | |
| Initial Screening | STARTED | Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase | 0 | |
| Initial Screening | STARTED | Placebo/Low Dose/Moderate Dose (PLM) | 0 | |
| Initial Screening | STARTED | Placebo/Moderate Dose/Low Dose (PML) | 0 | |
| Initial Screening | STARTED | Low Dose/Moderate Dose/ Placebo (LMP) | 0 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mild | ||
| Total, all-cause mortality | Moderate | ||
| Total, all-cause mortality | High | ||
| Total, other adverse events | Mild | 0 | 230 |
| Total, other adverse events | Moderate | 0 | 40 |
| Total, other adverse events | High | 0 | 199 |
| Total, serious adverse events | Mild | 0 | 230 |
| Total, serious adverse events | Moderate | 0 | 40 |
| Total, serious adverse events | High | 0 | 199 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants3
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA021765 | Cancer Center Support Grant (CCSG) | ROBERTS, CHARLES | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| R01CA078957 | LEARNING IMPAIRMENTS AMONG SURVIVORS OF CHILDHOOD CANCER | MULHERN, RAYMOND K | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1999 to 2003 | NIH RePORTER |
| U01CA081445 | STJUDE PARTICIPATION IN PEDIATRIC BRAIN TUMOR CONSORTIUM | KUN, LARRY E | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1999 to 2003 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00576472
GET https://conductscience.org/api/trials/v1/NCT00576472/registered?page=2