Women's Health Communication Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Women's Health Communication Study (NCT05359952), a randomized na study. The primary outcome is Feasibility - Retention.

2. Clinical Question

3. Trial Design

The Women's Health Communication Study (NCT05359952) was a completed, randomized, parallel-group pilot study sponsored by Fox Chase Cancer Center. The registry lists the study phase as not applicable. It reports an enrollment of 32 participants, with 21 assigned to Starting the Conversation and 11 assigned to Sexual and Menopausal Health Resources Only.

The intervention was behavioral and combined an educational video, workbook, and resource list. The comparator was also behavioral and consisted of the resource list alone. The study was unmasked. The registry lists a start date of 2022-02-09 and a primary completion date of 2022-08-22; its status is completed.

The primary outcome was retention, defined as the number of enrolled participants completing the final study survey at 2 months. The study description also identifies patients’ beliefs about communication and communication during clinic visits as areas of interest. Secondary outcomes include self-efficacy, several measures of clinical communication, sexual function and activity, and psychological distress related to depression.

The registry record does not report the method used to generate or conceal random assignments, detailed eligibility criteria, a formal sample-size justification, or a statistical analysis plan. It also does not report an analysis population definition. Those details should not be inferred from the randomized design or the posted results.

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

Reasons for not completing this period:

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 Feasibility - Retention, measured over 2 months.

The primary endpoint, feasibility-retention, counts enrolled participants who completed the final study survey at 2 months. It is a count-based measure: its focus is whether participants remained in the study through the final survey, rather than whether sexual-health communication or another clinical outcome changed.

Retention is useful in a pilot study because it describes whether the planned follow-up was completed by participants in each assigned group. Such information can help characterize the practicality of carrying out a study with these materials and this follow-up period. It does not, by itself, establish that the intervention is acceptable, that participants used the materials as intended, or that communication changed.

The posted results report 20 of 21 participants completing the final survey in Starting the Conversation and 11 of 11 in the resource-only group. These are observed completion counts and group sizes. The registry record does not report a separate acceptability endpoint or criteria defining a threshold for feasibility.

7. Results Posted in the Registry

• Sexual and Menopausal Health Resources Only: 100.0% (11/11) versus 95.2% (20/21) on control; risk difference 4.8 percentage points (95% CI -4.3 to 13.9), risk ratio 1.05 (0.95–1.16); unadjusted two-proportion z-test p = 0.462.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Clinical Communication - Discussion of Sexual Health

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Sexual and Menopausal Health Resources Only: 45.5% (5/11) versus 45.0% (9/20) on control; risk difference 0.5 percentage points (95% CI -36.2 to 37.1), risk ratio 1.01 (0.45–2.27); unadjusted two-proportion z-test p = 0.981.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sexual and Menopausal Health Resources Only and the control. The interval gives the range of effects that remain compatible with the data.

Clinical Communication - Raising Topic of Sexual Health

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Sexual and Menopausal Health Resources Only: 0.0% (0/11) versus 35.0% (7/20) on control; risk difference -35.0 percentage points (95% CI -55.9 to -14.1); unadjusted two-proportion z-test p = 0.026.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Sexual and Menopausal Health Resources Only than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Clinical Communication - Asking a Question About Sexual Health

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Sexual and Menopausal Health Resources Only: 27.3% (3/11) versus 45.0% (9/20) on control; risk difference -17.7 percentage points (95% CI -51.9 to 16.4), risk ratio 0.61 (0.21–1.78); unadjusted two-proportion z-test p = 0.332.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sexual and Menopausal Health Resources Only and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the study beyond retention to include self-efficacy, clinical communication, sexual function, sexual activity, and psychological distress related to depression. The posted communication findings do not show a uniform pattern across all measured behaviors: the observed group comparisons vary by outcome. This variation is unsurprising in a pilot with small groups and multiple measures, and it makes a single broad conclusion about communication inappropriate.

The primary endpoint concerns completion of follow-up, whereas secondary communication outcomes concern what participants reported or did in relation to sexual-health discussions. Retention can support interpretation of whether follow-up was achieved, but it is not evidence that communication changed. Conversely, an observed difference on a communication measure does not alter the primary retention result.

The registry lists secondary outcomes beyond the detailed communication results, including self-efficacy at post-intervention and 2-month follow-up, change in sexual function, sexual activity, and psychological distress. The registry record does not report results for every listed outcome in the detailed posted results. Absence of a posted result should not be treated as evidence of no effect.

Unadjusted secondary comparisons carry less weight because multiple outcomes create more opportunities for apparently notable findings by chance. The record does not report how multiplicity was addressed, which outcomes were designated confirmatory, or a hierarchy for interpreting them. These comparisons are best viewed as exploratory signals that may inform further study, not as standalone evidence of a reproducible effect.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Self-Efficacy - Post-Intervention
• Self-Efficacy - 2-Month Follow Up
• Clinical Communication - Discussion of Sexual Health
• Clinical Communication - Raising Topic of Sexual Health
• Clinical Communication - Asking a Question About Sexual Health
• Change in Sexual Function
• Sexual Activity
• Psychological Distress - Depression

9. Statistical Interpretation

10. Statistical Methods Explained

What does a risk difference describe?

For a binary outcome, a risk difference compares the proportion with the event in one group with the proportion in another. Here, the event for the primary outcome is completing the final study survey. A positive difference in the registry comparison indicates a higher observed completion proportion in the resource-only condition than in Starting the Conversation, according to the comparison’s stated ordering. The estimate is 0.048.

A risk difference is expressed on the absolute scale: it describes the gap between group proportions, rather than a relative change. The estimate is a sample-based comparison and is not a guarantee that the same difference would occur in another study. The interval around it matters, especially when the groups are small.

How should the confidence interval be read?

A confidence interval gives a range of values that are compatible with the observed data and the statistical method, while reflecting sampling uncertainty. It is not a range containing a known fixed proportion of individual outcomes, and it does not assign a probability to the true effect after the data have been observed. For retention, the reported interval extends from a small difference favoring Starting the Conversation to a larger difference favoring the resource-only condition. Because it includes zero, the data do not clearly distinguish the groups on this measure.

What does the unadjusted p-value indicate?

The primary comparison has an unadjusted p-value of 0.462. In general, a p-value describes how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the statistical model were true. It does not give the probability that the null hypothesis is true, measure the size or importance of a difference, or account for uncertainty not represented by the model. The registry record does not report the specific test used for this comparison or a fuller analysis specification.

What does the planning illustration mean?

For some posted secondary comparisons, a planning illustration expresses participants per arm for 80% and 90% power under stated assumptions. The registry describes these as calculations from the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the assumed effect is a stated fraction of the observed effect. These figures are illustrations, not the trial’s original sample-size justification and not observed power. They should not be interpreted as evidence that the study had a particular chance of detecting a true effect.

Planning from an observed effect can be especially unstable when an estimate comes from a small pilot: the observed value may not represent the effect that would be seen in a larger study. The illustrations are useful as a reminder that assumptions about effect size affect planning, but they do not establish the appropriate size or design of a future study. The registry record does not report the investigators’ own sample-size rationale.

Why do the communication results need caution?

Communication outcomes are also binary participant counts in the posted comparisons. Counts such as participants reporting a discussion or asking a question are easy to describe, but estimates based on small groups can vary substantially across samples. For outcomes with zero observed events in a group, relative measures may be difficult to estimate or interpret; the absolute counts and the uncertainty around comparisons are more informative than a claim that the underlying chance is zero.

The registry record lists several outcome measures and does not report a statistical analysis plan or reported analyses. It is therefore not possible to establish from the record which comparisons were prespecified as confirmatory, how missing outcome data were handled, or whether any adjustments were planned. Interpret the reported comparisons as limited evidence from a pilot, not as a fully specified confirmatory analysis.

11. Confidence Intervals and Precision

The retention estimate is a risk difference of 0.048. Its confidence interval extends from -0.043 to 0.139. Because the interval crosses zero, the data are compatible with no difference as well as with differences favoring either group. Its span also indicates that the estimate is not precise enough to pin down a narrow range of group differences.

The observed counts help put that uncertainty in context: 20 of 21 participants completed the final survey in Starting the Conversation, compared with 11 of 11 in the resource-only group. The groups are small, especially the comparator group, so a small change in the observed number of participants could materially affect a comparison. High completion in both groups does not remove that uncertainty about the difference between groups.

In general, confidence intervals are useful because they show both the direction and the range of uncertainty around an estimate. A p-value alone does not communicate that range. Neither the point estimate nor the interval addresses all possible sources of uncertainty: for example, the registry record does not report details of missing-data handling, the comparison test, or a prespecified analysis plan.

The secondary communication comparisons likewise should be read with attention to their uncertainty and small group sizes. A result that appears more pronounced is not necessarily more reliable, particularly when several outcomes are assessed. The record does not report multiplicity adjustment or a hierarchy that would identify which secondary comparisons should carry confirmatory weight.

12. Multiplicity, Missing Data and Analysis Populations

The registry identifies a broad set of outcomes, including retention, self-efficacy, clinical communication, sexual function, sexual activity, and psychological distress. Considering multiple outcomes raises the issue of multiplicity: when many statistical tests are conducted, some may appear notable even if there is no underlying difference. The registry record does not report a multiplicity adjustment, a prespecified testing hierarchy, or which secondary comparisons were intended to be confirmatory.

The detailed registry record lists no reported analyses. It also does not report an analysis plan specifying the statistical tests, covariate adjustment, analysis populations, or handling of missing outcome data. These omissions limit the ability to determine whether the displayed comparisons reflect prespecified procedures or how investigators intended to manage incomplete responses.

For the primary endpoint, the observed counts show that some participants in the intervention group did not complete the final survey, while all participants in the resource-only group did. The registry does not describe reasons for noncompletion or how missing survey data were treated in analyses. It also does not report whether analyses followed assignment regardless of intervention use, or whether a different analysis population was used.

These gaps do not invalidate the recorded counts, but they limit interpretation of the comparison and of the secondary findings. Missingness can matter if participants who do not complete follow-up differ systematically from those who do. The record does not provide enough information to assess that possibility. Results should therefore be understood as the posted observations, with uncertainty about unreported analysis and missing-data procedures.

13. 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 no serious adverse events, other adverse events, or deaths in either group. The recorded number at risk was 21 in Starting the Conversation and 11 in the resource-only group for both adverse-event categories; the recorded event counts were zero in each group.

These figures describe events recorded in this study. They do not show that an event is impossible, or establish that the intervention is free of risk. The groups are small, and the registry record does not provide further detail about adverse-event collection, definitions, timing, or attribution. No serious-event terms are listed. Interpret the absence of recorded events as a feature of the posted safety data, not as a broad safety conclusion.

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

The primary result shows that most enrolled participants completed the final survey in both randomized groups. The estimated difference is small in the context of the observed groups, but its confidence interval is broad enough to include differences in either direction. The unadjusted p-value does not provide clear evidence of a difference in retention between conditions.

This result is about feasibility as operationalized by final-survey completion. It does not demonstrate acceptability, because the registry does not report an acceptability measure or threshold. It also does not establish whether participants watched the video, used the workbook, reviewed the resources, or raised sexual-health concerns during a visit.

The secondary outcomes address communication and other health domains, but their small groups, multiple comparisons, and unreported analysis plan call for cautious interpretation. The results may help describe what was observed in this pilot and identify questions for further evaluation. They do not establish a consistent or generalizable effect across all communication behaviors or other outcomes.

The study is not evidence that the intervention does or does not work in other populations or clinical settings. The registry record describes women with gynecologic cancer and a specific set of educational materials and comparator resources. It does not provide the detail needed to extend the findings beyond the participants and procedures recorded.

15. Why This Trial Matters Statistically

This trial is statistically informative because it separates a feasibility question from questions about communication and health outcomes. Retention is a practical pilot measure, but it is not a substitute for the outcomes the intervention is intended to address. Keeping those questions distinct prevents completion of follow-up from being mistaken for evidence of changed communication.

The observed retention counts are high in both groups, while the comparison remains uncertain. This illustrates why a point estimate alone is not enough: the interval shows how much uncertainty remains around the difference. In a small randomized pilot, such uncertainty is important even when the observed counts look encouraging as a feasibility signal.

The study also demonstrates why secondary findings need careful framing. Several communication and other outcomes were considered, while the registry record does not report a multiplicity plan or analysis specification. An apparent pattern across measures can be useful for generating hypotheses, but unadjusted comparisons should not be treated as conclusive evidence.

Finally, the planning illustrations based on observed effects are not observed power and do not replace the investigators’ original design rationale, which is not reported in the registry record. Distinguishing illustrative calculations from a trial’s prespecified design helps prevent overinterpretation of small pilot results and clarifies what further evidence would be needed.

16. 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 enrollment was 32 participants, with an unequal allocation of 21 to Starting the Conversation and 11 to the resource-only condition. These small groups make the comparisons imprecise, particularly for binary outcomes with few or no observed events. The primary retention interval includes differences in either direction.

The registry record does not report detailed eligibility criteria, the randomization procedure, allocation concealment, a sample-size justification, or a statistical analysis plan. It does not explain how missing data were handled, why participants did not complete the final survey, or which analysis populations were used. These omissions constrain assessment of bias and analytic choices.

There are multiple secondary outcomes, and the record does not report a multiplicity strategy or a prespecified hierarchy. Some outcomes listed in the registry are not accompanied by detailed posted results. The available results therefore cannot establish a comprehensive pattern across all intended outcomes.

The study compared a multicomponent educational intervention with a resource list alone. The registry record does not report adherence or use of the materials, so observed outcomes cannot be linked to actual exposure to particular components. The results also arise from the specific gynecologic cancer population and clinical context described in the record; broader applicability is not established.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Women's Health Communication Study — NCT05359952.
• Registry record last updated 2024-09-25; status last verified 2024-09.
• Results first posted 2024-09-25.
• 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.

20. Record Summary

NCT05359952 was a completed randomized, unmasked, parallel-group pilot study sponsored by Fox Chase Cancer Center. It enrolled 32 participants with gynecologic cancer, assigning 21 to Starting the Conversation and 11 to sexual and menopausal health resources only.

The primary endpoint was completion of the final study survey at 2 months. The registry reports 20 completions in the intervention group and 11 in the resource-only group. Its comparison gives a risk difference of 0.048, a confidence interval from -0.043 to 0.139, and an unadjusted p-value of 0.462.

Secondary outcomes include communication, self-efficacy, sexual and psychological outcomes. Interpretation is limited by small groups, multiple outcomes, and statistical and missing-data procedures not reported in the registry record.