Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer (NCT00416572), a randomized na study. The primary outcome is Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)..

2. Clinical Question

3. Trial Design

The registry record identifies NCT00416572 as a completed, randomized, parallel trial sponsored by Carnegie Mellon University. Enrollment was 252. The condition listed is breast neoplasms, and the trial title describes younger women who had recently finished treatment for Stage I or Stage II breast cancer. The phase is recorded as not applicable. The record does not provide a specific age range or fuller eligibility criteria.

Three conditions are described: an education intervention, a nutrition education intervention, and a control condition receiving care as usual. The education intervention consisted of 4 2-hr sessions, while the nutrition education intervention also consisted of 4 2-hr sessions. The nutrition description emphasizes information and encouragement about measurable healthy-eating goals and adaptive approaches to problems. The education description states aims related to illness uncertainty and coping, but its text is incomplete in the registry record.

Although the study is labeled randomized and parallel, the registry record does not make clear how the named interventions map onto the randomized groups or whether the two interventions were compared separately or in combination. Allocation concealment, the randomization procedure, and masking are not described beyond the record's designation of no masking. The record lists baseline, post-intervention at 4 months, and final follow-up at 13 months for the depressive-symptom outcome. It does not report the schedule or results for the other outcome measures in the information available. The status is completed, but completion alone does not supply evidence about the direction or size of an outcome difference.

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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.

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 Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)., measured over Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention)..

The primary outcome was depressive symptoms measured using an abbreviated 10-item CES-D. The record says scores ranged from 0, indicating no depressive symptoms, to 24, indicating high levels of depressive symptoms in the trial sample. The measure was recorded as a mean with standard deviation, in units on a scale. Assessments were planned at baseline, post-intervention at 4 months, and final follow-up at 13 months.

In general, a continuous scale can represent variation in symptom levels rather than reducing responses to a simple event-or-no-event outcome. A mean describes the central level of scores in a group; a standard deviation describes how spread out individual scores are around that mean. Repeated assessments can describe patterns over time, but interpreting an intervention effect requires a clearly defined comparison between groups and time points.

The registry record does not report the mean scores, standard deviations, between-group estimates, or confidence intervals for this endpoint. It also does not identify one primary comparison among the listed assessment times. Therefore, the measure and its intended timing can be described, but the observed level of depressive symptoms and the precision of any group difference cannot be determined from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The trial is recorded as randomized and parallel, with no masking. In general, random allocation is intended to make assigned groups comparable on average at the start of a study, while a parallel design follows different groups under their assigned conditions. These design labels do not establish how allocation was performed or whether groups were balanced in this trial. The randomization procedure and allocation concealment are not reported in the registry record. The no-masking designation indicates that the record does not describe masking, but further information about who knew assignments is not reported.

What does a mean and standard deviation describe?

The primary outcome was treated as a continuous measure and summarized using a mean and standard deviation. In general, a mean gives a group's average score. A standard deviation describes variation among individual scores, rather than uncertainty about the mean itself. The two measures answer different questions: the mean describes the group's central score, while the standard deviation describes how dispersed the scores are. The registry record provides the measure's scale range, from 0 to 24, but not the group summaries at any assessment time.

A group mean alone would not establish an intervention effect. For a randomized comparison, interpretation generally depends on a contrast between groups, such as a difference in scores or a difference in change from baseline. The appropriate contrast depends on the prespecified analysis plan and the scientific question. The registry record does not report the planned contrast, the numerical estimates, or confidence intervals for depressive symptoms.

Why does the assessment schedule matter?

The outcome was assessed at baseline, post-intervention at 4 months, and final follow-up at 13 months. Baseline measurement can describe scores before the post-intervention assessments; later measurements can describe outcomes over follow-up. In general, repeated measurements from the same participant are related, so an analysis should account for that dependence if it models more than one time point together. An analysis that compares groups at a particular time has a different interpretation from one that compares change over time or models a group-by-time pattern. Which approach was used is not reported in the registry record.

The record explicitly notes that the primary outcome has several categories or time points and was not reduced to one comparison. This matters because the reader cannot identify a single primary contrast from the posted outcome description. The record also lists 3 outcome measures and 12 analyses. In general, examining multiple outcomes, times, or contrasts raises questions about which tests were planned and how the chance of false-positive findings was handled. The statistical plan and any multiplicity adjustment are not reported in the registry record.

What would a confidence interval add?

In general, a confidence interval communicates uncertainty around an estimated effect. A narrow interval indicates greater precision under the analysis assumptions, whereas a wide interval indicates less precision. It is not a direct measure of the probability that a particular effect is true. A confidence interval can also show whether estimates compatible with the data include effects in different directions or of different sizes. No confidence interval for the primary outcome is reported in the registry record, so precision cannot be assessed.

How should planning assumptions be understood?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed trial outcomes and not evidence that the trial had a particular probability of detecting an effect. The registry record does not report the trial's own sample-size justification or the numerical planning results in the information available. The assumption of equal allocation between two arms in a planning illustration does not resolve the unclear mapping of the three named conditions to the randomized comparisons.

Over-dispersion is a general concern when variability in data is greater than a model assumes; underestimating variability can make uncertainty appear smaller than it is. The primary measure is described as continuous and summarized with a standard deviation, but the registry record does not report model diagnostics or whether over-dispersion was assessed. It would therefore be inappropriate to assert that this issue affected the analysis.

Finally, the registered analysis population included women who agreed to random assignment and completed all three assessments, irrespective of group attendance. In general, analyzing only participants with complete repeated assessments can affect how representative the analyzed sample is if completion relates to outcome or assignment. The record does not report how missing assessments were handled or compare included and excluded participants. These limitations constrain interpretation of the analysis but do not establish the direction of any bias.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome was assessed at baseline, post-intervention at 4 months, and final follow-up at 13 months. The registry record notes that the outcome has several time points and was not reduced to one comparison. It also lists 3 outcome measures and 12 analyses. Together, these details mean the intended primary contrast is not clear from the registered outcome description. The multiplicity strategy, including whether any adjustment was planned, is not reported in the registry record.

The stated primary-outcome population comprised women who agreed to random assignment and completed all three assessments, regardless of attendance at group sessions. This describes a complete-assessment analysis population, rather than specifying how all randomized participants were handled. The registry record does not report how many participants completed the assessments, how many had missing outcome data, or the reasons for missingness. It does not describe imputation, a model for incomplete repeated measures, sensitivity analyses, or how participants with partial assessments were treated.

In general, missing data can affect both the representativeness of an analysis and the precision of its estimates. The consequences depend on why measurements are missing and on the assumptions used to address them. Likewise, testing multiple outcomes or time points without a clear hierarchy can complicate interpretation of isolated findings. These are general concerns, not claims about what occurred in this trial. The registry record does not provide enough detail to judge the handling of missing data or multiplicity.

11. Safety Results

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

Other (non-serious) adverse events

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

The registry safety entries list 83 participants at risk in the education intervention, 85 in the nutrition education intervention, and 84 in the control condition. Serious adverse events are reported as 0 in each condition. Other adverse events are also reported as 0 in each condition. The record does not list serious-event terms, and death counts are not reported.

These figures are counts recorded for the listed groups; they do not provide event descriptions, timing, severity details beyond the serious-event category, or information about how events were collected. A zero count in the registry is not proof that no event of any kind occurred, nor does it describe outcomes outside the recorded categories or reporting period. In general, safety comparisons depend on consistent event definitions, follow-up, and ascertainment across groups. Those details are not reported in the registry record.

The safety entries should not be used to infer an effect on depressive symptoms or the broader aims of the interventions. They are separate from the primary outcome, for which group scores and comparative estimates are not reported.

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

The registry record describes a randomized parallel trial of educational approaches for younger women who had recently completed treatment for early-stage breast cancer. It identifies an education intervention, a nutrition education intervention, and care as usual, and states that the study aimed to assess physical and psychological functioning. The primary registered measure was depressive symptoms on an abbreviated 10-item CES-D, assessed at baseline, post-intervention at 4 months, and final follow-up at 13 months.

That description does not establish what happened to participants' scores. The registry record does not report group means, standard deviations, effect estimates, confidence intervals, or primary-outcome test results. It also does not identify one comparison across the several assessment times. No conclusion about the direction, size, statistical significance, or precision of an intervention effect can be drawn from the registered information.

In general, a trial can inform a question only to the extent that its design, analysis, and results are available and interpretable. A randomized label describes an intended allocation approach, but does not substitute for outcome estimates or details of the analysis. Likewise, a completed status does not indicate whether an intervention changed outcomes. The safety entries showing zero reported serious adverse events are not evidence of efficacy and do not answer the primary outcome question.

The record can therefore be read as documentation of the research question, intervention formats, measurement schedule, and stated analysis population. It cannot support a claim that either intervention improved or did not improve depressive symptoms, or that the interventions were equivalent to care as usual. Those conclusions would require results and a clearly defined comparison, which are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial raises several statistical issues that commonly matter in behavioral and clinical research. First, it has repeated assessments of a continuous symptom measure: baseline, post-intervention at 4 months, and final follow-up at 13 months. Such a schedule can address outcomes at different stages, but the interpretation depends on whether the target is a group difference at a particular assessment, change from baseline, or a pattern across time. The registry record does not identify one primary contrast.

Second, the record lists 3 outcome measures and 12 analyses. When multiple outcomes or time points are examined, a clear prespecified hierarchy and transparent reporting help readers distinguish the main question from additional analyses. The registry record does not report the statistical plan or any multiplicity strategy. This does not show that no such plan existed; it means the registered information does not allow readers to assess it.

Third, the stated analysis population required completion of all three assessments, regardless of session attendance. This distinction is important in trials where participants may attend sessions differently or miss follow-up measurements. The registry record does not say how incomplete outcome data were handled, so the consequences for representativeness and precision cannot be evaluated.

Finally, the record describes both education and nutrition education alongside care as usual, while leaving the precise comparison structure unclear. Clear reporting of group assignment, the intended contrast, estimates, and uncertainty is essential for interpreting a randomized study. Here, the design and outcome definitions are documented, but the primary results needed to connect those elements are not reported in the registry record.

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 principal limitation for interpreting this trial from the registry record is the absence of primary-outcome results. Although the measure, scale range, and assessment times are described, group-level means and standard deviations, comparative estimates, confidence intervals, and test results are not reported. This prevents assessment of the direction, magnitude, or precision of any difference.

The registered primary outcome spans multiple assessment times, and the record notes that it was not reduced to one comparison. The intended primary contrast is therefore unclear. The record also lists 3 outcome measures and 12 analyses but does not report the statistical plan or multiplicity handling. These omissions limit interpretation of which findings, if any, were intended to answer the main question.

Other design details are also limited. The record identifies a randomized parallel design and no masking, but does not describe the randomization procedure or allocation concealment. It names three conditions, but does not make the intervention-to-comparison structure clear. The specific age range, fuller eligibility criteria, and further details of the education intervention are not reported in the registry record.

The primary-outcome population includes participants who completed all three assessments, regardless of attendance. The number of participants with complete assessments, the handling of incomplete records, and sensitivity analyses are not reported. The registry safety entries list zero serious and other adverse events in each group, but event-collection details and death counts are not reported. These limitations describe gaps in the registered information; they do not establish that the trial lacked procedures or analyses beyond what the registry record reports.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer — NCT00416572.
• Registry record last updated 2016-11-07; status last verified 2016-09.
• Results first posted 2016-11-07.
• 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

NCT00416572 is recorded as a completed, randomized parallel trial sponsored by Carnegie Mellon University, with enrollment of 252 and no masking. The trial concerned younger women recently treated for Stage I or Stage II breast cancer and listed education, nutrition education, and care-as-usual conditions.

The primary outcome was depressive symptoms measured with an abbreviated 10-item CES-D, with scores ranging from 0 to 24 and assessments at baseline, post-intervention at 4 months, and final follow-up at 13 months. The analysis population was described as women who agreed to random assignment and completed all three assessments, regardless of attendance.

The registry record does not report outcome estimates or identify one comparison across the assessment times. It lists 3 outcome measures and 12 analyses. Serious and other adverse events are recorded as 0 in each condition; deaths are not reported.