Increasing Breast Cancer Screening in Chinese Immigrants: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Increasing Breast Cancer Screening in Chinese Immigrants (NCT05089292), a na na study. The primary outcome is Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire.

2. Clinical Question

3. Trial Design

The registry lists this study as completed, with a start date of 2021-07-01 and a primary completion date of 2022-12-13. It is a single-group behavioral study of narrative breast health education for Chinese immigrants. Allocation is listed as not applicable, and masking is listed as none. The study is not presented as a randomized comparison, and the record does not describe a control arm.

The study summary describes two aims. The first involved in-depth interviews about breast cancer knowledge, perceived barriers and benefits or risks related to mammography, perceived susceptibility, fatalism, screening intention, acculturation, language preference, and health literacy. The summary says 60 women were recruited for these interviews. The second aim was a pilot test of the intervention, with recruitment planned at community sites serving Chinese immigrants in New York City. The summary describes plans to recruit 96 women for that aim and says recruitment was anticipated to start in March of 2022.

The summary states that 156 participants would be recruited during the entire study, while the enrollment field records 99. The registry record does not reconcile the planned figures with the enrollment entry or specify how enrollment was distributed across the aims. The study is marked completed, but that status alone does not establish which planned activities or targets were achieved.

The record identifies change in breast cancer knowledge as a secondary outcome. It lists four outcome measures, but does not report their observed values or describe how the interview aim and pilot aim were combined in the analysis. The protocol’s detailed statistical plan, including any analysis populations or interim analyses, is not reported in the registry record.

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 Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire, measured over immediately post presentation (presentation approximately 1 hour).

The primary endpoint is the number of participants whose score was above 80% on a feasibility and acceptability questionnaire. The questionnaire was intended to be completed immediately after the narrative education presentation, described as approximately 1 hour. The scale ranges from 0% to 100%, with higher scores indicating greater acceptability. The registry describes 80% as an arbitrary cutoff used to determine whether the intervention would be considered acceptable for the study.

Counting participants above a prespecified threshold turns a continuous questionnaire score into a binary outcome: each participant either meets the cutoff or does not. This can make a decision rule easy to communicate, but it also discards information about how far scores lie from the cutoff. Participants with scores just on opposite sides of 80% are classified differently, while people with quite different scores on the same side are grouped together. The threshold is described as arbitrary, not as a clinical standard or a validated boundary.

The endpoint addresses immediate reported acceptability after the presentation. It is not itself a measure of mammography completion, a change in screening behavior, or a longer-term health outcome. The record does not report the number meeting the cutoff, the score distribution, the denominator used for this endpoint, or any uncertainty estimate. Thus, the intended measure is clear, but its observed result cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count of participants who crossed a questionnaire-score threshold. As a general statistical description, this is a binary outcome at the participant level: the score either exceeds the stated cutoff or it does not. A count is interpretable only alongside the number of participants whose questionnaire data were included. If that denominator is unavailable, the count alone does not show how common the outcome was among those assessed. Neither the threshold count nor its analysis denominator is reported in the registry record.

For binary outcomes, a proportion and its uncertainty are often useful descriptive summaries. A confidence interval expresses the range of values compatible with the observed data under the method used; it is not a guarantee that the true value lies within that range. Precision depends on the amount of information and the observed outcome pattern. Here, the endpoint estimate and a confidence interval are not reported in the registry record, so neither the magnitude nor the precision of acceptability can be evaluated.

The threshold itself matters statistically. The questionnaire scale is described as running from 0% to 100%, with higher scores indicating greater acceptability, and the record sets an arbitrary cutoff of 80%. Converting scores into categories makes the endpoint straightforward to state, but removes distinctions among scores within each category. It also makes results sensitive to the chosen boundary: small score differences around the cutoff can change classification. A continuous score distribution could give complementary information, but the distribution and any analysis of the continuous score are not reported in the registry record.

Because the design is single-group, the primary endpoint is naturally read as a descriptive assessment of participants after receiving the education. In general, a single-group post-program measure can describe responses in that group but cannot separate the intervention’s effect from other explanations, such as participant selection, prior experience, or changes over time. A concurrent comparison group can help address some alternative explanations, but none is described in this record. No causal effect estimate comparing groups is reported.

The outcome timing is immediate after the presentation, which the record describes as approximately 1 hour. This timing makes the endpoint a measure of immediate response, not evidence about persistence of acceptability or later screening behavior. The registry does not report a later follow-up measure for this primary endpoint. The separately listed secondary outcome, change in breast cancer knowledge, could address a different aspect of the program, but its definition, analysis, and observed result are not reported in the registry record.

The registry’s planning illustration is explicitly not the trial’s own design. Its stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with effects framed as stated fractions of an observed effect. These assumptions describe a planning exercise, not this single-group study’s allocation. The registry record does not report the study’s own sample-size justification, or clarify a study-specific power calculation. Planning illustrations are not observed power and do not establish that the trial could detect a particular effect.

The record lists four outcome measures and zero statistical analyses. That is not enough to identify the statistical methods that were used or planned. The analysis model, handling of repeated or incomplete questionnaire data, any adjustment for covariates, and the approach to uncertainty are not reported in the registry record. General statistical practice cannot fill in those study-specific details. No recalculated estimate can be derived from the posted information, because the primary outcome count and its denominator are absent. The interpretation should therefore remain at the level of design and endpoint definition, rather than infer an effect size or statistical significance.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Chinese Immigrants")
n      <- c(99)
events <- c(99)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Chinese Immigrants  99  99  100.0  96.3  100.0  96.3  100.0  96.4  100.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, including the primary acceptability endpoint and a secondary outcome described as change in breast cancer knowledge. It does not report how the outcomes were prioritized analytically beyond identifying the primary endpoint, or whether any multiplicity strategy was planned. Multiplicity refers generally to the increased chance of at least one apparently noteworthy result when several outcomes or hypotheses are examined. Whether that issue affected this study cannot be determined from the registry record, because the analysis plan and results are not reported.

Missing-data handling is also not described. The registry does not state how unanswered questionnaire items, incomplete surveys, or participants without post-program assessments were handled. It does not report the number of participants with primary endpoint data or identify whether the denominator differed from enrollment. These details matter because the interpretation of a count depends on who was assessed and whether missing responses could be related to participants’ experiences.

Analysis populations are not specified. The record does not say which participants were included in the primary analysis, whether all enrolled participants were expected to contribute, or how participants from the interview and pilot aims were distinguished for analysis. The enrollment field and recruitment plans are not reconciled, so they cannot establish an endpoint-specific analysis set.

These omissions do not prove that investigators failed to consider multiplicity, missing data, or analysis populations. They mean those procedures are not reported in the registry record. Without the analysis details and outcome values, readers cannot assess how these choices might affect the reported estimates.

12. 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 reports 0 serious adverse events and 0 other adverse events for the Chinese Immigrants group. It lists 99 participants at risk for both categories and records 0 deaths. These are the event figures entered in the record; they are not an estimate of comparative safety because the study has no described control group.

A zero count should be read as no events recorded in that category in the registry entry, not as proof that no events occurred under any definition or that an intervention has no risk. The record does not list serious adverse-event terms, and it does not describe how events were collected, what observation period applied, or how completely safety information was captured. Those details are not reported in the registry record.

The group’s at-risk figures do not establish how many participants completed every safety assessment or the duration of observation. Nor do they identify whether the event counts cover all study aims or only the intervention group. The figures should therefore be interpreted narrowly as registry-reported counts, without extending them to a broader safety conclusion.

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

The record identifies a culturally and linguistically adapted narrative breast health education program for Chinese immigrants in New York City and specifies an immediate post-presentation acceptability endpoint. That information clarifies what the study set out to assess. However, the primary outcome result is not reported in the registry record. No conclusion about the observed acceptability scores or the number meeting the threshold can be drawn from the posted entry.

Even if the endpoint result were available, it would answer a limited question: how participants responded to a questionnaire immediately after the presentation, according to the stated cutoff. It would not by itself show that mammography screening increased. The record’s long-term goal of increasing screening rates is broader than the primary endpoint, and an immediate acceptability measure is not equivalent to screening completion or a sustained change in behavior.

The study’s single-group design also means it does not provide a direct estimate of how outcomes compare with an alternative. Without a control group, any observed post-program response would be descriptive rather than a randomized estimate of the program’s effect relative to another approach. The registry does not report a causal analysis or an observed comparison.

The record’s study summary describes interview and pilot aims, while the enrollment field and planned recruitment figures do not align clearly. That difference makes it especially important not to assume that the enrollment count is the endpoint denominator or that all planned recruitment targets were met. The study is marked completed, but the registry record does not report the results needed to judge the primary question, the secondary knowledge outcome, or changes in screening.

In short, the entry provides useful information about the population, intervention, design, and intended measurement. It does not establish that the program was acceptable by its stated rule, improved knowledge, increased screening, or changed health outcomes. Those conclusions would require outcome data and analysis details not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically notable because its stated long-term aim and its primary endpoint address different levels of evidence. Increasing screening is the broader goal, while the primary measure captures immediate questionnaire acceptability. Keeping those concepts distinct prevents a favorable response to education from being mistaken for a change in screening behavior.

The study also illustrates how a threshold can simplify communication while narrowing what a measure conveys. Classifying questionnaire scores around the stated 80% cutoff produces a count with a clear interpretation under the study’s rule, but it does not retain the full score distribution. The cutoff is described as arbitrary, so the threshold should be understood as a study decision rather than a general standard.

A single-group design can be appropriate for describing a pilot program, but it does not provide the same comparative evidence as a design with a control group. The absence of a comparator is central when interpreting any future reported outcome: a post-program measurement can describe participants’ responses, but it cannot alone establish what would have happened without the program.

Finally, the difference between the enrollment entry and recruitment plans highlights the importance of transparent denominators. For a count endpoint, readers need to know who was assessed and who was included in the analysis. The record does not report that information or the primary result. As a result, the study’s rationale and measurement approach are visible, while the statistical evidence needed to assess the primary question remains unavailable.

15. 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.

A central limitation for interpretation is that the registry record does not report the primary endpoint result, its denominator, or an uncertainty estimate. The stated measure can be described, but its observed level and precision cannot be assessed. The listed secondary outcome of change in breast cancer knowledge also has no reported result.

The single-group design has no described control condition, so it cannot directly estimate a difference from another approach. The primary endpoint is assessed immediately after the presentation and concerns questionnaire acceptability, not mammography completion or longer-term screening behavior. The endpoint therefore has a narrower scope than the study’s long-term goal.

The registry lists 99 enrolled participants, while the study summary describes planned recruitment of 156 across the full study, including separate plans for the interview and pilot aims. The record does not reconcile these figures or identify the primary endpoint analysis population. It is not possible to determine from the enrollment entry how many participants contributed to the acceptability measure.

The endpoint uses an arbitrary 80% threshold on a 0% to 100% scale. Categorization can conceal differences in scores and makes classification depend on the chosen cutoff. The score distribution and any complementary analysis of the full scale are not reported in the registry record.

Additional limitations include the absence of reported methods for missing data, multiplicity, statistical analysis, and sample-size justification. The registry’s planning illustration uses assumptions that are not the single-group design itself. These reporting gaps prevent a fuller assessment of precision, robustness, and the relationship between the study’s aims and its analyses.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Increasing Breast Cancer Screening in Chinese Immigrants — NCT05089292.
• Registry record last updated 2024-06-10; status last verified 2024-06.
• Results first posted 2024-06-10.
• 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.

19. Record Summary

The registry identifies a completed, single-group behavioral study of narrative breast health education for Chinese immigrants in New York City. It lists no masking and no allocation to comparison groups. The study began on 2021-07-01 and reached primary completion on 2022-12-13.

The primary endpoint counts participants scoring above 80% on an immediate feasibility and acceptability questionnaire. The record describes the scale and cutoff but does not report the resulting count, denominator, or statistical uncertainty. Change in breast cancer knowledge is listed as a secondary outcome, with no result reported.

The enrollment field records 99, while the summary describes plans for 156 participants across interview and pilot aims; the entries are not reconciled. Statistical analysis details, missing-data methods, and analysis populations are not reported in the registry record. The adverse-event entry records 0 serious events, 0 other events, and 0 deaths for the Chinese Immigrants group.