Reducing Metabolic Syndrome Among Breast Cancer Survivors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Reducing Metabolic Syndrome Among Breast Cancer Survivors (NCT03719677), a na na study. The primary outcome is Self Reported Behavioral Automaticity Index.

2. Clinical Question

3. Trial Design

The registry describes a completed, pilot, single-group pre-post study of a behavioral intervention for rural breast cancer survivors. The study is listed as having no phase, no allocation, and no masking. These entries indicate that the registry does not describe a phased drug trial, randomized allocation, or blinded assessment. The design has no concurrent control group; it is not a randomized comparison between like-for-like arms.

The brief summary describes the intervention as personalized and low burden, with most interactions conducted by telephone coaching. It states that the 12-week program was intended for community-dwelling rural breast cancer survivors aged 40 and older. Its components include three home-based face-to-face consultations with a therapist and 9 weekly habit telephone coaching sessions. It also describes implementation intentions, environmental modifications, and tailored text messages to support physical activity and dietary habits and address unmet needs. These are descriptions of the planned intervention, not evidence that every intended component was received by every participant.

The registry lists enrollment as 7, whereas the brief summary describes 48 people as the intended intervention group for assessing feasibility. The record does not explain the difference, describe recruitment or completion by participant, or clarify how many people contributed to the primary endpoint. The study status is completed. The listed start date is 2018-11-06, and the primary completion date is 2020-06-01.

A pre-post design can describe within-group changes over time, but without a concurrent comparator it cannot separate intervention-associated change from other explanations, such as natural change, events during follow-up, or measurement effects. In this record, even a within-group outcome estimate is not reported, so the design description alone cannot establish what happened to the primary measure.

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

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 Self Reported Behavioral Automaticity Index, measured over From week 0-2.

The primary endpoint is the Self Reported Behavioral Automaticity Index. The registry describes it as a score on a scale, with a mean as the measure of interest and standard deviation as the stated dispersion measure. Scores range from 1-7, with higher scores indicating a stronger habit. The endpoint is intended to capture participants’ reported automaticity, or the strength of a behavior as a habit, rather than a clinical event or a direct measure of physical activity or diet.

Habit strength is relevant to this intervention because the program aims to support the formation of physical activity and dietary habits. A self-reported automaticity score can therefore serve as a measure aligned with the intervention’s behavioral goal. However, a score is an indicator of reported habit strength; it does not by itself establish whether a participant met a dietary or activity recommendation, whether health changed, or whether any change was caused by the intervention.

The registry gives the endpoint timeframe as “From week 0-2.” It does not report endpoint values, a mean change, a standard deviation from observed participants, or a statistical analysis. It also does not clarify in the posted results how this timeframe relates to the intervention’s described 12-week duration. As a result, the endpoint’s stated purpose can be explained, but its observed outcome and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group pre-post pilot, but it does not report a statistical analysis for the primary endpoint. The explanations below are general statistical context; they do not imply that the study used any particular unreported method.

What does a pre-post estimate describe?

In general, a pre-post analysis compares measurements from the same group at different assessment times. It can summarize whether the measured outcome tended to rise or fall over time, and by how much, if the measurements and an analysis are reported. The registry identifies the Self Reported Behavioral Automaticity Index and a timeframe of “From week 0-2,” but gives no values or calculated change. Thus, no within-group change can be stated from the record.

A pre-post change is not the same as a treatment effect estimated against a control group. Without a concurrent comparator, the observed change, if reported, could reflect intervention exposure, but could also reflect other changes over time, participant expectations, repeated measurement, or events unrelated to the intervention. These are general limitations of interpreting uncontrolled change, not claims about what occurred in this study.

What do a mean and standard deviation convey?

In general, a mean summarizes the central level of a continuous measure across observations. A standard deviation describes how dispersed individual observations are around that mean. Together they can describe the distribution’s location and variability, but do not reveal the full distribution or identify every participant’s score. The registry specifies mean and standard deviation for the primary endpoint, yet does not report the observed values. No claim about the group’s typical score or the spread of scores is therefore possible.

How would uncertainty be assessed?

In general, a confidence interval describes uncertainty around an estimated quantity under the assumptions of the statistical method used. A narrower interval indicates greater precision, while a wider interval indicates less precision. It is not a range containing a known proportion of individual participant values, and it does not eliminate possible bias from the study design or measurement. No confidence interval for the primary outcome is reported in the registry record, so its precision cannot be assessed.

A p-value, when calculated for a specified hypothesis and model, describes how compatible the data are with that hypothesis under the model’s assumptions. It does not measure the size or practical importance of an effect, and it does not establish causality. No primary endpoint p-value or analysis is posted, so statistical significance cannot be evaluated.

Why does the design matter?

General statistical interpretation depends on how participants are assigned and what comparisons are available. A randomized concurrent control can help distinguish intervention-associated change from changes that would also have occurred without the intervention. This registry instead identifies a single group and no allocation. Therefore, any future interpretation of reported pre-post results would need to remain descriptive or acknowledge the limits of causal attribution. No adjusted comparison is reported.

Precision also depends on the amount and quality of outcome information available, not only on the enrollment entry. The registry lists enrollment as 7, but does not state the number with endpoint data or the number included in an analysis. The brief summary’s intended group of 48 does not resolve the missing analysis population. Without outcome availability and analytic details, the adequacy of the data for estimating change cannot be assessed.

How should planning calculations be read?

General sample-size calculations estimate how many observations a future study might need under specified assumptions about the target effect, variability, significance level, power, and design. They are planning tools, not results from the current participants. The registry’s stated illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The record also distinguishes per-arm counts for non-time-to-event outcomes from total event counts for time-to-event outcomes.

Those assumptions describe a hypothetical two-arm illustration, whereas the study is listed as a single-group intervention. Any resulting participant counts are therefore planning illustrations, not observed power and not a report of the trial’s own design justification. The record does not report a sample-size justification, and no inference about adequate power should be drawn from these planning assumptions.

What analysis details are absent?

The registry does not report a statistical model, a test for the primary endpoint, an adjustment strategy, a missing-data method, or a definition of the analysis population. It also does not report an estimate, uncertainty interval, or p-value. Without these details and the underlying outcome summary, readers cannot reproduce or assess an endpoint analysis. The absence of reported analyses should not be mistaken for evidence that a particular analysis was performed or that a null result was obtained.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and zero analyses. It does not report a multiplicity plan, an adjustment for multiple comparisons, or a hierarchy of confirmatory outcomes. With no posted endpoint analyses, there are no reported hypothesis tests to evaluate for multiplicity. It would be incorrect to assume that an adjustment was either used or unnecessary based only on the listed primary measure.

The record identifies the primary endpoint as the Self Reported Behavioral Automaticity Index, but does not provide the number of participants with an observed score, the number included at each assessment, or the analysis population. It does not report missingness, reasons for missing measurements, participant withdrawal, or a method for handling missing data. These items are important because outcome availability can affect both the amount of information and the interpretation of a pre-post estimate.

In general, missing-data methods rely on assumptions about why measurements are absent. Different assumptions can lead to different estimates, especially when missingness is related to participants’ outcomes or experiences. A complete-case analysis, imputation method, or sensitivity analysis cannot be attributed to this study because none is reported in the registry record. The enrollment entry of 7 does not establish how many primary endpoint observations were available.

The brief summary describes 48 people as the intended intervention group, while the registry’s enrollment field lists 7. The record does not reconcile these figures. It also does not say whether enrollment refers to a particular stage, whether all listed enrollees completed follow-up, or how the primary outcome was analyzed. Accordingly, neither the number analyzed nor the consequences of missing data can be determined from the posted record.

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.

The registry lists one intervention group, titled Habit Development Intervention, with 7 at risk for serious adverse events and 0 serious adverse events recorded. It also lists 7 at risk for other adverse events and 0 other adverse events recorded. Deaths are listed as 0. No top serious adverse event terms are listed.

These counts describe the safety entries in the registry. They do not establish that no adverse experiences occurred outside the categories or reporting process represented in the record, and they do not show that the intervention is risk-free. The record does not give event narratives, severity details beyond the serious/other categories, follow-up duration for safety, or a comparison group. A single-group listing also cannot provide a comparative estimate of risk against usual care or another intervention.

The listed at-risk counts should not be treated as proof that each person contributed the same observation time or had complete safety follow-up; those details are not reported in the registry record. The counts are best read narrowly as the adverse-event figures that were posted for the intervention group, rather than as a comprehensive evaluation of safety.

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

The record documents a completed pilot study of a habit-development intervention for rural breast cancer survivors. It describes a behavioral program intended to support physical activity and dietary habit formation and address unmet needs during the survivorship transition. It also identifies self-reported behavioral automaticity as the primary outcome measure, with higher scores indicating stronger reported habits.

What the record does not provide is the primary outcome result. There are no observed scores, pre-post change, uncertainty interval, or endpoint analysis. It is therefore not possible to say whether reported habit strength increased, decreased, or remained similar, or how precise any such estimate might be. The lack of posted results is not evidence of no change, and it is not evidence of a positive change.

The design also limits what could be concluded even if a within-group change were posted. Because the study is described as single-group and has no concurrent comparator, observed change would not isolate the intervention’s effect from other explanations. The registry does not report a randomized comparison, an adjusted analysis, or information that would resolve that limitation.

The discrepancy between the registry enrollment of 7 and the summary’s intended group of 48 further limits interpretation of the study’s reach and data availability. The record does not explain the difference or report the number included in the primary outcome analysis. No assumption about recruitment, completion, or analyzed participants should be made from these entries alone.

Accordingly, the record supports a description of the intervention plan, the stated endpoint, and the posted safety counts. It does not support a conclusion about effectiveness, the size or certainty of an outcome change, or the feasibility of delivering the program. Those judgments require results and analysis details not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable because its registry record separates a detailed intervention description from a limited outcome record. The intervention is described as a pilot one-arm pre-post program, and a primary behavioral measure is named. Yet the record reports zero analyses and no numerical primary endpoint results. This illustrates why a registered endpoint and a completed status are not substitutes for an estimate of outcome change.

The distinction between intended enrollment and listed enrollment also matters. The summary describes 48 intended participants, while the enrollment field lists 7. Without an explanation or an analysis population, readers cannot determine how many people were recruited, completed the program, or contributed endpoint data. These are not interchangeable quantities, and the record does not establish their relationship.

The single-group design is another key statistical feature. It can be useful for describing an intervention pilot and observing within-group patterns, but it does not provide the concurrent counterfactual comparison needed to attribute change confidently to an intervention. Even if results were posted, causal claims would need to reflect this design limitation.

Finally, the record’s stated sample-size assumptions concern a hypothetical two-arm planning illustration, while the registered study is single-group. This contrast is a reminder that sample-size planning outputs must be interpreted in light of the design and assumptions they represent. They are not observed power, and they do not supply missing endpoint results or a trial-specific design rationale. The main statistical lesson is the importance of transparent reporting of analyzed participants, outcome estimates, uncertainty, and methods alongside the intervention description.

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.

Several limitations are specific to the registry record. First, the primary endpoint is named and described, but no observed result or analysis is posted. The direction and magnitude of any change in the Self Reported Behavioral Automaticity Index therefore cannot be assessed.

Second, the record lists enrollment as 7, while the brief summary describes 48 people as intended to receive the intervention. There is no explanation for the difference. The number of participants who completed the intervention, posted endpoint measurements, or were included in an analysis is not reported in the registry record.

Third, the single-group pre-post design has no concurrent control group. This limits causal interpretation because changes over time cannot be separated from other possible influences using a randomized comparison. Allocation is listed as not applicable and masking as none.

Fourth, the primary timeframe is recorded as “From week 0-2,” while the intervention is described as lasting 12 weeks. The registry does not clarify how the assessment timeframe relates to the full intervention period. It also does not report outcome timing details beyond the stated timeframe.

Finally, statistical methods are not reported: there is no model, test, missing-data approach, analysis population, multiplicity strategy, or sample-size justification. These omissions prevent assessment of how an outcome estimate would have been produced and how robust it might be. The posted safety counts are also limited; no comparator or detailed safety follow-up information is reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Reducing Metabolic Syndrome Among Breast Cancer Survivors — NCT03719677.
• Registry record last updated 2020-11-20; status last verified 2020-10.
• Results first posted 2020-11-20.
• 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

The registry record describes a completed pilot, single-group pre-post behavioral intervention for rural breast cancer survivors during the survivorship transition. It lists enrollment as 7 and identifies the primary outcome as the Self Reported Behavioral Automaticity Index, with scores ranging from 1-7 and higher scores indicating stronger habit. The intervention summary describes a 12-week program, including home-based consultations and weekly telephone coaching. The primary timeframe is stated as “From week 0-2.”

No primary endpoint values or analyses are reported. The brief summary describes 48 intended participants, a figure the record does not reconcile with listed enrollment. The posted safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths among the intervention group’s listed at-risk counts. The record does not report a comparator, statistical analysis methods, missing-data handling, or a sample-size justification.