Education Tools to Support Pediatric Survivor Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Education Tools to Support Pediatric Survivor Care (NCT04257058), a na na study. The primary outcome is Survivor Care Knowledge Scale.

2. Clinical Question

3. Trial Design

This completed study is registered as NCT04257058, with the title “Education Tools to Support Pediatric Survivor Care.” Its official title describes predicting childhood cancer survivors’ transition readiness and transfer outcomes. Emory University is listed as the sponsor. The study is classified as a single-group model, with allocation recorded as not applicable and masking listed as none. Phase is listed as not applicable.

The registry record lists an enrollment of 89. It gives a study start date of 2022-06-07 and a primary completion date of 2024-04-13; status is completed. These record details describe the study’s registration and timing, but do not establish how many participants contributed data to a particular outcome assessment. For the primary outcome, the record defines the analyzed population separately at each time point by completion of the corresponding visit and assessment. Those time-specific counts are not reported in the registry record.

Participants completed an online pre-test survey using REDCap and then reviewed electronic media in REDCap. Study staff confirmed that the material had been reviewed and scheduled a post-test survey. The primary outcome timeframe is baseline and 2 weeks post-intervention. Further details about survey completion, follow-up procedures, or what happened after scheduling are not reported in the registry record.

Because the record describes a single group rather than randomized intervention and control groups, any comparison between the listed assessment occasions would be a within-study time comparison, not a randomized treatment contrast. The registry record does not report whether the same participants contributed both assessments, how incomplete follow-up was handled, or which statistical model was used.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: This study and the data presented below only refers to the young adult survivors and does not include parents. Parents were not enrolled in this study. "Participants" refer to young adult cancer survivors.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Survivor Care Knowledge Scale, measured over Baseline, 2 weeks post-intervention.

The primary endpoint is the Survivor Care Knowledge Scale. It is described as a 15-item multiple-choice quiz assessing knowledge of content covered in the electronic educational materials. The total score ranges from 0-15, and higher scores are associated with a better outcome. The registry record specifies assessment at baseline and 2 weeks post-intervention.

Knowledge is a direct outcome for a study intended to evaluate educational materials: it concerns whether participants know the content covered by those materials. Measuring the outcome before and after the educational activity can describe knowledge at each assessment occasion and, if an appropriate analysis is conducted with participant-level data, can assess change over time. In general, a measured change does not by itself establish that the intervention caused that change. Without a separate comparison group, other explanations for an observed time difference cannot be ruled out by randomization.

The registry record does not report the mean score, standard deviation, number analyzed at either assessment, amount of change, confidence interval, or test result. It therefore does not establish the direction, size, or precision of any observed change in knowledge. The record’s definition of the population analyzed at each time point also means the assessment counts cannot be inferred from enrollment.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The available design information identifies a single-group behavioral study with baseline and 2 weeks post-intervention assessments for the primary knowledge outcome. The registry record does not report the statistical analysis used for that outcome. It gives no estimate, standard error, confidence interval, test statistic, or p-value, and lists 0 analyses. The interpretation must therefore remain at the level of design and measurement rather than an assessment of an estimated effect.

What would a baseline-to-follow-up comparison describe?

In general, a repeated-measure comparison examines measurements taken from participants on different occasions. If the same participants contribute both measurements, a paired analysis can account for the fact that observations from one person tend to be related. The estimated change is then based on within-person differences, rather than treating all measurements as independent. If different participants contribute at different occasions, the analysis has a different structure. The registry record does not report whether the primary outcome analysis paired observations, whether the same participants completed both assessments, or how missing follow-up assessments were treated.

The record’s population definition is specific to each time point: participants must have completed the corresponding visit and the specific assessment. That definition does not say how many participants met it at either occasion. Nor does it establish that every person who completed the baseline assessment completed the post-intervention assessment. Without those details and the observed data, it is not possible to reconstruct an analysis or determine whether the analyzed groups at the assessment occasions were comparable.

How should a score and its uncertainty be read?

The outcome is a continuous score on a scale ranging from 0-15, with higher scores associated with a better outcome. In general, a mean gives the arithmetic average of scores for the analyzed participants, while a standard deviation describes how dispersed individual scores are around that average. These are different kinds of information: the mean locates the group’s average score, and the standard deviation describes variation among scores. The registry record names mean and standard deviation as the reported summary approach, but gives no values for either assessment occasion.

In general, a confidence interval for a mean or a change estimate represents uncertainty in the estimate under the assumptions of its statistical method. It is not a range containing every participant’s score, and it does not show whether individual participants improved. A narrower interval generally indicates greater precision for the estimated quantity, while a wider interval indicates less precision. No confidence interval is reported in the registry record, so the precision of the primary outcome estimate is not available.

What can a single-group design establish?

In general, a pre-test and post-test comparison can describe temporal change in the measured outcome among participants with the relevant assessments. It cannot, on its own, distinguish the effect of an intervention from all other reasons scores might change over time. A control group can help address some competing explanations, particularly when allocation is randomized, but this study is recorded as a single-group model and allocation is not applicable. The registry record does not describe a randomized comparison.

This does not make a within-group result meaningless; it defines the question that such a result can answer. It can describe measured scores at the scheduled assessments and their difference if the analysis and data are reported. It cannot establish the counterfactual question of what those participants’ scores would have been at follow-up without the educational material. The registry record contains no outcome estimate with which to evaluate even the descriptive change.

What do the planning assumptions mean?

The record’s sample-size assumptions describe a planning illustration based on an observed effect, rather than the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a fraction of the observed effect. These assumptions do not describe this registered single-group study as a randomized two-arm trial. They are not evidence that such an allocation occurred, and planning sample sizes are not observed power.

In general, a sample-size calculation asks what amount of information would be needed to detect a specified effect under chosen assumptions. Its result depends on those assumptions and on the endpoint and analysis. A planning illustration cannot establish that a study was adequately powered for its actual analysis, particularly when the design assumptions differ from the registered design. The record does not report a trial-specific sample-size justification or the numerical planning sample sizes. It also does not report an interim-analysis plan or a statistical analysis plan.

For time-to-event outcomes, the record notes that planning illustrations use total events, while other illustrations use participants per arm. The primary outcome in this study is a continuous score, not a time-to-event endpoint. No new sample-size calculation or power estimate can be derived from the posted information. Any claim about observed power would be inappropriate; observed power is not a substitute for reporting an effect estimate and its uncertainty.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists the Survivor Care Knowledge Scale as the primary outcome and names secondary outcomes covering benefits for survivor care, barriers for survivor care, perceived susceptibility for late effects, intentions for survivor care, and change in the Perceived Health Competence Scale. It states that there are 6 outcome measures, but does not name any additional outcome in the information available. The record lists 0 analyses and does not report results for the primary or secondary outcomes.

When a study evaluates several outcomes or several comparisons, the chance of at least one apparently unusual result can increase if each is tested separately without accounting for the collection of tests. In general, multiplicity methods can address this issue by controlling a specified error rate or by using a hierarchy of outcomes. The registry record does not report whether multiplicity was considered, whether the primary outcome had a prespecified analysis hierarchy, or whether any adjustment was used. It is therefore not possible to assess how multiple outcomes were handled.

The outcome population is defined as participants who completed the corresponding visit and specific assessment. This specifies who qualifies for the reported summary at a given time point, but does not explain missing-data methods. The number analyzed at each time point, reasons for missing assessments, and any imputation or sensitivity analyses are not reported in the registry record. The record also does not say whether analyses used all available assessments, only participants with both measurements, or another approach.

In general, missing data can affect both the amount of information available and the interpretation of an estimate, especially when missingness is related to participants’ outcomes or circumstances. The direction and extent of any such effect cannot be inferred without information about missingness and the analysis. The registry record does not report an analysis population beyond its assessment-completion definition, nor does it provide enough information to evaluate the consequences of incomplete assessments.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: stroke (1.1%), myocardial infarction (1.1%).

The adverse-event record lists 89 at risk for serious adverse events and 2 serious adverse events. It lists Stroke and Myocardial infarction as serious-event terms, each at 1.1%. The record lists 89 at risk for other adverse events and 0 other adverse events, as well as 0 deaths. These are the posted safety figures; they do not supply a detailed account of event timing, severity beyond the serious classification, or participant-level circumstances.

In general, a serious adverse event count is a safety description, not by itself evidence that the intervention caused an event. Establishing whether an event was related to an intervention requires additional information, such as the event’s timing and the study’s causality assessment. Those details are not reported in the registry record. The record also does not provide a comparison group, so it cannot support a comparative estimate of event risk between intervention and control groups.

The percentages attached to the two serious-event terms are reported as 1.1% each. They should be read as the registry’s posted figures, not as estimates of causal risk attributable to the educational material. The number at risk in the serious and other-event listings does not establish the number with complete primary-outcome assessments. Safety and knowledge outcomes have different definitions and should not be conflated.

12. What the Result Does, and Does Not, Mean

The record establishes that a completed, single-group study evaluated electronic educational material for young adult survivors of childhood cancer. It identifies Survivor Care Knowledge Scale performance as the primary outcome and specifies assessment at baseline and 2 weeks post-intervention. It also lists secondary topics and provides a limited set of safety counts. These details describe what the study set out to assess and what safety information is posted.

The record does not report primary or secondary outcome results. In particular, it provides no knowledge-score means, standard deviations, change estimate, confidence interval, or test result. Enrollment of 89 is not a substitute for the number analyzed at each assessment, which is also not reported. Thus the record does not show whether scores changed, the direction or magnitude of any change, or how precisely a change was estimated.

Even if a within-group score difference were available, the single-group design would support a description of change over time, not a randomized causal comparison. In general, measurements can change for reasons other than the intervention, and a concurrent control group can help distinguish those influences. No such group is described in the record.

The safety record lists 2 serious adverse events, with Stroke and Myocardial infarction each reported at 1.1%, 0 other adverse events, and 0 deaths. These figures describe recorded events but do not establish whether the intervention caused them. The registry record does not provide event-level details or a causal assessment.

Accordingly, the available information supports an account of the study’s population, intervention, design, outcome definition, timing, and posted safety figures. It does not support a conclusion about whether the educational materials changed knowledge, whether any change was important or precise, or whether events were related to the intervention.

13. Why This Trial Matters Statistically

This trial illustrates an important distinction in clinical research: registration details and outcome results answer different questions. The registry record describes the intended evaluation of educational materials, the single-group design, and the knowledge measure. Those details help readers understand what was assessed and when. But without the observed scores and an analysis, they cannot establish what happened to measured knowledge.

The distinction between enrollment and outcome-specific analysis is also important. The record lists an enrollment of 89, yet defines the analyzed population for each primary outcome time point by completion of that visit and assessment. Because the number meeting that definition at each occasion is not reported, enrollment alone cannot indicate how much data informed a comparison or how precise it would be.

The study also highlights how design determines the reach of an interpretation. A baseline-to-follow-up comparison in a single group can describe change, whereas a randomized comparator can support a stronger contrast between intervention strategies. The record’s planning assumptions refer to equal allocation between two arms, but its registered model is single-group. Separating an illustrative planning scenario from the actual study design prevents a planning calculation from being mistaken for evidence about the completed study.

Finally, safety counts require their own context. Serious events are important to report, but counts and percentages alone do not establish attribution. The posted record identifies event terms and counts without reporting the causal assessments needed to interpret a relationship to the educational material. Taken together, these points show why transparent outcome values, analysis methods, missing-data information, and safety context are essential for statistical interpretation.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most consequential limitation for interpreting this record is that no primary or secondary outcome results are reported. The record identifies the knowledge scale and its assessment timeframe but gives no score summaries, change estimate, uncertainty interval, or statistical test. It lists 0 analyses. As a result, the record cannot support an estimate of the intervention-associated change in knowledge or its precision.

The population contributing to each time point is not quantified. Although enrollment is listed as 89, the record defines the analyzed population by completion of the corresponding visit and assessment. It does not report the number analyzed at either occasion, the extent of incomplete follow-up, or how missing measurements were handled. This limits assessment of the amount and completeness of outcome information.

The single-group design has no separate control group described, and allocation is recorded as not applicable. A comparison across assessment occasions would therefore not be a randomized contrast. Without a concurrent comparator, temporal change cannot be cleanly separated from other influences. The record does not report enough information to assess whether participants’ follow-up experience differed in ways that might affect the measured scores.

Further limitations include the absence of a reported statistical analysis plan, multiplicity approach, or trial-specific sample-size justification. The planning assumptions describe an illustration based on an observed effect and a two-arm allocation, which does not match the listed single-group model. The registry record does not report how that illustration relates to the study’s actual analysis. Safety information is also limited: event terms and counts are listed, but timing and causality assessments are not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Education Tools to Support Pediatric Survivor Care — NCT04257058.
• Registry record last updated 2025-05-15; status last verified 2025-05.
• Results first posted 2025-05-15.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT04257058 is a completed, single-group behavioral study sponsored by Emory University. It enrolled 89 young adult survivors of childhood cancer and evaluated electronic educational material. Participants completed an online pre-test survey in REDCap, reviewed electronic media, and had a post-test survey scheduled after staff confirmed review. The primary outcome is Survivor Care Knowledge Scale performance at baseline and 2 weeks post-intervention. The scale is a 15-item multiple-choice quiz scored from 0-15, with higher scores associated with a better outcome.

The registry record does not report outcome values, analyses, or the number analyzed at each assessment. It lists 0 analyses. Safety information includes 2 serious adverse events, with Stroke and Myocardial infarction each reported at 1.1%, 0 other adverse events, and 0 deaths. The single-group design does not provide a randomized control comparison, and the record does not report event causality assessments.