Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study (NCT03624972), a randomized na study. The primary outcome is Self-Reported Self-Efficacy for Communicating About Sexual Health Issues.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel-group study with no masking. Its listed status is completed. The study title identifies a patient intervention study, and the brief summary describes random assignment to the video intervention plus resources or resources alone. A separate Clinician Arm is also described: clinicians consented to have clinic visits audio recorded, but no outcomes data were collected from clinician participants. That arm should not be confused with a third patient treatment condition.

The registry record lists enrollment as 153. The brief summary describes 128 breast cancer outpatients as the number to be randomized, while the arm-level record lists 71 participants in Resources Only and 73 in Resources + Video for the primary outcome. For the primary measure, all participants in Resources Only and 71/73 in Resources + Video completed the assessment at 2 weeks; two participants in the latter arm withdrew before that assessment. The record does not explain the difference between the enrollment figure and the number described in the brief summary, so the reason should not be inferred.

The registry lists the study start as 2018-05-27 and primary completion as 2019-12-31. These dates describe the recorded study timeline, not the timing of any individual participant's intervention or follow-up. The primary outcome was assessed at 2 weeks. Listed secondary measures include retention at 2 weeks and other outcomes assessed at 2 months.

Allocation concealment, the sequence-generation method, protocol deviations, and the trial's original sample-size justification are not reported in the registry record. Although the study is described as randomized, the available record does not support more detailed claims about how randomization was implemented. Nor does it establish whether the statistical methods posted for individual outcomes were prespecified. These omissions matter when interpreting a small, unadjusted comparison: the arm summaries are informative about the recorded endpoint, but they do not reveal every design or analysis decision.

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: Participants complete consent and baseline survey before being assigned to a study group.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment.

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 Self-Efficacy for Communicating About Sexual Health Issues, measured over 2 weeks.

The primary endpoint is self-reported self-efficacy for communicating with a breast cancer clinician about sexual-health concerns. It is a mean score on a 0-10 scale, with higher values indicating greater confidence. Two items ask about confidence in talking about sexual health and asking about sexual health; the mean across those items forms the score. The record defines the response anchors as 0 for not at all confident or not at all, and 10 for extremely confident or very much.

This measure addresses a proposed, near-term target of the intervention: whether patients feel more able to raise sexual-health concerns with a clinician. A self-efficacy score is not a direct count of conversations, a measure of clinician response, or a measure of sexual function. It captures participants' reported confidence, which can be relevant to a communication-focused intervention while remaining distinct from observed communication behavior and health outcomes.

The endpoint was assessed at 2 weeks. The registry record describes the measure and timeframe but does not report a threshold for a clinically important change, a validation analysis in this study, or a rationale for choosing this particular assessment time. The arm means were 8.5 for Resources Only and 8.8 for Resources + Video, with standard deviations of 1.8 and 2.1. Those summaries locate the average responses, while the standard deviations describe variation among participants. Neither the mean nor the scale alone indicates how participants' conversations unfolded.

7. Results Posted in the Registry

• Resources + Video: mean 8.80 versus 8.50 on control; difference 0.30 (95% CI -0.34 to 0.94), standardized effect d = 0.15; z-test p = 0.361.

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.

Retention Rates (Feasibility)

• 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:
  • Resources + Video: 97.3% (71/73) versus 100.0% (71/71) on control; risk difference -2.7 percentage points (95% CI -6.5 to 1.0), risk ratio 0.97 (0.94–1.01); unadjusted two-proportion z-test p = 0.160.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Resources + Video and the control. The interval gives the range of effects that remain compatible with the data.

General Self-Efficacy for Communication With Provider

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Resources + Video: mean 22.20 versus 21.60 on control; difference 0.60 (95% CI -0.48 to 1.68), standardized effect d = 0.18; z-test p = 0.277.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Resources + Video and the control. The interval gives the range of effects that remain compatible with the data.

Barriers to Communicating About Sexual Health

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Resources + Video: mean 27.80 versus 29.00 on control; difference -1.20 (95% CI -4.33 to 1.93), standardized effect d = -0.13; z-test p = 0.453.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Resources + Video and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover feasibility, acceptability, communication-related measures, sexual activity, sexual function, and other health outcomes. The posted comparisons include retention at 2 weeks and measures of general self-efficacy for communication with a provider and barriers to communicating about sexual health at 2 months. This broader set asks whether any pattern extends beyond the primary, more focused confidence measure.

Across the secondary comparisons with numerical estimates posted, the directions are not identical: one concerns retention, one is a communication-confidence score, and one is a barriers score. Their confidence intervals include the no-difference value, and the unadjusted p-values do not give strong evidence of a difference. Taken together, these comparisons do not establish a consistent advantage across the measured domains. They also do not establish that the groups are equivalent, because the estimates have uncertainty and no equivalence margins are reported.

The primary result and the secondary results address related but distinct questions. The primary endpoint concerns confidence about talking or asking about sexual health with a breast cancer clinician at 2 weeks. The secondary communication measures broaden that construct or use a later assessment, while retention and sexual outcomes measure other aspects of the study. A pattern across different measures can provide context, but it cannot substitute for a precise primary estimate or prove a mechanism.

Secondary findings carry less weight when many outcomes are examined and the analysis plan for handling multiplicity is not reported. With multiple opportunities to observe an apparently notable result, unadjusted p-values can overstate the evidence associated with any one comparison. Conversely, a lack of small p-values does not demonstrate absence of effects, especially when estimates are imprecise. The registry lists 25 outcome measures and 19 posted secondary outcomes, but does not report an adjustment strategy or a hierarchy for interpreting them.

Some listed secondary outcomes do not have numerical comparisons in the record used for this interpretation. Their inclusion as planned or recorded outcomes should not be mistaken for evidence about their results. Overall, the secondary material is best treated as exploratory context around the primary question, not as independent confirmation or contradiction of it.

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

• Recruitment Rates (Feasibility)
• Retention Rates (Feasibility)
• Retention Rates (Feasibility)
• Intervention Acceptability
• Sexual Activity
• Sexual Function
• General Self-Efficacy for Communication With Provider
• Barriers to Communicating About Sexual Health

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant's score is a numeric value on a 0-10 scale, and the posted arm summaries use means and standard deviations. A mean describes the average score in an arm. A standard deviation describes the spread of individual scores around that average; it is not the uncertainty in the mean and is not a confidence interval. The primary comparison reports the difference between the arm means, with Resources + Video compared with Resources Only.

The posted primary means are 8.5 and 8.8, and the unadjusted mean difference is 0.3. A positive difference in this direction means that the observed average score was higher in Resources + Video. The comparison is unadjusted: it does not account for other participant characteristics or use an adjusted model in the posted result. The registry record does not report an adjusted primary analysis, covariates, or a detailed statistical model, so none should be assumed.

A confidence interval describes a range of estimates reasonably compatible with the observed data under the method's assumptions. The 95% interval for the mean difference is -0.343 to 0.943. Because this interval crosses zero, it includes the possibility of no mean difference. It also includes values below and above zero, so the direction is uncertain. The interval does not assign a 95% probability to the true effect; its standard interpretation refers to the long-run performance of the interval procedure under repeated sampling and its assumptions. The underlying assumptions and exact test method for the posted analysis are not reported in the registry record.

The p-value is 0.361. In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified null model and its assumptions. It is not a measure of the probability that the null hypothesis is true, nor a measure of effect size or clinical importance. Here it is identified as unadjusted. The record does not say whether the comparison was part of a prespecified hierarchy or how multiplicity was handled across outcomes.

The primary measure was completed by 71 participants in each arm. The description notes that all participants in Resources Only completed it, while 71/73 in Resources + Video completed it and two withdrew before the 2-week assessment. A complete-case comparison uses observed outcome data; it can differ from the target comparison if missingness is related to the outcome or to participant characteristics. This is a general concern, not evidence that such bias occurred in this study. The registry record does not report imputation, weighting, sensitivity analyses, or a reason for withdrawal.

The posted arm summaries and comparison are simple unadjusted calculations from summary statistics. The sponsor's own analysis does not take precedence in this case because no discrepancy is flagged in the record. Still, the record does not provide enough detail to establish whether the posted comparison matches a prespecified primary analysis. The protocol's planned analysis and sample-size justification are not reported in the registry record.

General explanation: random allocation is intended to make treatment groups comparable on average, including with respect to factors that are measured and unmeasured. It does not guarantee that the groups will be identical in a particular trial. A parallel-group design assigns participants to one condition, and outcomes are compared between groups. Masking is listed as none, so the record does not describe participants or study personnel as masked to assignment. For an educational intervention, awareness of the materials may be inherent, but the registry does not give further masking details.

General explanation: a confidence interval can be wide when the estimate is imprecise, when outcome variability is substantial, or when the available sample is limited relative to the effect being estimated. More observations can improve precision under suitable assumptions, but they do not remove bias from measurement, missing data, or design. The primary interval is wide enough to encompass both a negative and a positive mean difference, so the point estimate alone should not be treated as a precise measurement of the intervention's effect.

General explanation: over-dispersion matters primarily when a statistical model assumes less variability than the data actually have, as can occur in count or binary outcomes. Excess variability can make standard errors too small and confidence intervals too narrow if not handled appropriately. The primary endpoint is a continuous score and is summarized with a standard deviation; the registry record does not report an over-dispersion assessment or a model requiring such an assumption. It would therefore be inappropriate to claim that over-dispersion was present or affected this analysis.

For the binary retention outcome, the posted comparison is a risk difference. In general, a risk difference expresses the difference in the observed proportions with an event between groups. For the continuous outcomes, a mean difference retains the score's original scale and is directly interpretable in score points. These are distinct effect measures and should not be compared as if they shared units. The registry record does not report a multiplicity adjustment or detailed analysis methods for the secondary outcomes.

11. Confidence Intervals and Precision

The primary estimate is a mean difference of 0.3 points on the 0-10 self-efficacy scale. Its 95% confidence interval is -0.343 to 0.943. This interval is the key precision statement: the observed data do not pin down a single value closely, and estimates on either side of zero remain compatible with the interval. The point estimate gives the center of the comparison, but it should not be read without the interval.

The interval crosses zero, so it does not distinguish a positive difference from no difference or a negative difference at the conventional two-sided 0.05 significance level. This does not establish equivalence. To support equivalence, a study would ordinarily need an appropriate design and a prespecified margin defining what differences are small enough to count as equivalent. Such a margin and an equivalence analysis are not reported in the registry record.

The arm standard deviations were 1.8 for Resources Only and 2.1 for Resources + Video. They describe variation in scores among participants, whereas the confidence interval describes uncertainty about the between-arm mean difference. The primary measure included 71 participants in each arm, with two withdrawals before assessment in the video arm as described in the record. The registry does not report a missing-data sensitivity analysis, so the interval should not be interpreted as accounting for any unobserved outcomes beyond the method used for the posted comparison.

Precision is not the same as importance. The record does not state what size of score difference would matter to patients or clinicians, and a confidence interval cannot supply that judgment by itself. It also cannot show whether confidence translated into actual discussion, changed provider communication, or affected sexual-health outcomes. The interval quantifies uncertainty for this score comparison at this assessment, not for every endpoint or clinical context in the study.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants or total events. The registry's planning illustration assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It uses the observed effect as its reference and considers detecting 100%, 75%, or 50% of that observed effect. The original trial's own sample-size assumptions and justification are not reported in the registry record.

For the primary comparison, planning for 100% of the observed effect gives 668 participants per arm for 80% power and 894 participants per arm for 90% power. Planning for 75% of the observed effect gives 1,187 participants per arm for 80% power and 1,588 participants per arm for 90% power. Planning for 50% of the observed effect gives 2,669 participants per arm for 80% power and 3,573 participants per arm for 90% power.

In general, power is the probability that a study will detect an effect of a specified size under the planning assumptions if that effect is present. The 80% and 90% columns represent different target probabilities of detecting the assumed effect; the higher target generally requires more participants. A smaller effect is harder to distinguish from random variation, so the planning figures rise as the assumed fraction of the observed effect gets smaller. The accompanying curve visualizes that relationship; it does not turn the trial's observed result into a guarantee about another study.

These are planning illustrations based on an effect estimated from the observed results, not a reconstruction of the original design. They are not observed power. The registry record does not report that the study was planned using these estimates, and the estimates should not be read as evidence that the present study was adequately or inadequately designed.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.300; pooled standard deviation σ = 1.956.
2. n = 2 × (1.96 + 0.842)² × 1.956² / 0.300² = 667.2, rounded up to 668 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.300000000000001                      # observed difference in means
sigma <- 1.95576072156079                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3624972)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 668 (80% power), 894 (90% power)
 75% of observed effect: n per arm = 1,187 (80% power), 1,588 (90% power)
 50% of observed effect: n per arm = 2,669 (80% power), 3,573 (90% power)
power.t.test: 668.1 
Simulated power at n = 668 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The study includes a primary outcome and a broad set of secondary outcome measures. The registry lists 25 outcome measures and 19 posted secondary outcomes. When several outcomes are assessed, the chance of at least one apparently unusual result can increase if each is judged separately with an unadjusted threshold. In general, multiplicity procedures or a prespecified hierarchy can help control how strongly a collection of results is interpreted. The registry record does not report a multiplicity adjustment, a hierarchy, or a family of outcomes designated for a shared error-rate target.

The available secondary comparisons are identified as unadjusted. Their p-values should therefore be read as outcome-specific statistics rather than as multiplicity-controlled evidence across all outcomes. The record also does not report whether those comparisons were prespecified, exploratory, or selected after the data were examined. Without that information, isolated secondary results merit caution, and a nonsignificant result cannot be used to rule out an effect.

Missing outcome data are relevant to the primary comparison. The registry states that 71/73 participants in Resources + Video completed the 2-week measure and that two withdrew before that assessment; all participants in Resources Only completed it. The record does not give the reasons for withdrawal, an imputation method, a sensitivity analysis, or a comparison of participants with and without observed outcomes. It therefore does not show how missing scores were handled beyond describing the available endpoint population.

The record does not report a detailed analysis population, such as whether all randomized participants were included under an intention-to-treat approach, nor does it describe exclusions after randomization. The enrollment figure and the arm-specific counts are reported, but their relationship to the planned number in the brief summary is not explained. These gaps limit assessment of whether the analysis preserved the randomized comparison and how robust the result is to missing data.

The original statistical analysis plan, assumptions behind the primary analysis, and interim analyses are not reported in the registry record. No interim analysis should be inferred from the completion dates or outcome postings. The absence of these details does not establish that procedures were absent; it means the registry record does not document them. A careful reading separates the numerical results that are posted from analysis choices that cannot be verified from this record.

15. 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 serious adverse events and other adverse events for three groups: Resources Only, Resources + Video, and the Clinician Arm. Each group has zero participants with a serious adverse event and zero with another adverse event in the posted figures. Deaths are also listed as zero in each group. The at-risk counts are 71 for Resources Only, 73 for Resources + Video, and 9 for the Clinician Arm.

These figures report what was recorded in the registry for the specified groups; they do not show that every possible unwanted event was assessed or that no event could occur outside the recorded definitions or reporting period. The registry does not provide serious-event terms, because none are listed, or further detail on collection procedures, observation windows, severity criteria, or causal attribution. The clinician participants consented to audio recording and had no outcomes data collected, so their inclusion in the adverse-event listing should be understood separately from the patient intervention comparison.

Zero recorded events in these groups is a descriptive safety summary, not evidence that the interventions are risk-free. The figures also do not measure the intervention's communication or health effects. No medical conclusion follows from the adverse-event counts alone.

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

The result describes a comparison in self-reported confidence, not a direct measure of whether patients raised sexual-health concerns during a visit. At 2 weeks, the mean score was 8.8 with resources plus the video and workbook, compared with 8.5 with resources alone. The estimated unadjusted difference was 0.3 points, and the confidence interval extended across zero. The posted data therefore leave meaningful uncertainty about the direction and size of the difference in this measure.

The result does not show that the video had no effect. A confidence interval that includes zero can arise when the data are not precise enough to distinguish the estimated effect from no difference. It also does not show that the video was effective: the point estimate alone is not sufficient evidence, and the interval includes a range of possible effects. The record gives no threshold for an important score change, so the practical significance of the observed difference cannot be determined from the reported scale and means alone.

The comparator received sexual- and menopausal-health resources, so the randomized contrast evaluates adding the video and workbook to resources. It does not estimate the effect of resources compared with receiving no educational material, or of the video without its accompanying workbook. The endpoint is also specific to confidence about communication with a breast cancer clinician. It does not establish effects on sexual function, sexual activity, psychological well-being, quality of life, or other health outcomes.

General explanation: a trial result is most useful when the endpoint, comparison, estimate, uncertainty, and analysis population are considered together. Here, the record gives the endpoint definition and summary statistics, but does not report an important-difference threshold, detailed missing-data methods, or a complete statistical analysis plan. Those omissions constrain how broadly the numerical result can be interpreted.

The study is completed and its registry results provide a record of the posted outcomes. They should be understood as evidence about this study's participants, intervention contrast, endpoint, and assessment time. They do not by themselves determine what will happen in other clinical settings or for individual patients, and they do not support medical advice.

17. Why This Trial Matters Statistically

This study illustrates why an intervention's intended mechanism and its measured endpoint need to be kept distinct. The video aims to support communication about sexual concerns, while the primary endpoint measures self-reported confidence to talk or ask about those concerns. Confidence is relevant to communication, but is not the same as an observed conversation. A careful statistical interpretation stays within the construct actually measured.

The comparison also highlights the importance of the control condition. Both patient groups had access to sexual- and menopausal-health resources; the randomized contrast adds a video and workbook to those resources. That design question is narrower than whether educational support of any kind is useful. Making the contrast explicit prevents the numerical estimate from being attributed to a different intervention question.

Precision is central to reading the result. The point estimate is modest on the defined scale, but the interval crosses zero and spans effects in both directions. The p-value alone cannot communicate that range, and a nonsignificant comparison is not proof of equality. The registry does not state a meaningful-change threshold or an equivalence margin, so neither should be retrofitted to the result.

Finally, the study has multiple outcomes and some missing primary measurements, while the registry record does not report a multiplicity strategy or detailed handling of missing data. Those details are not reasons to discard the posted summaries. They are reasons to describe the summaries precisely, avoid over-interpreting secondary comparisons, and distinguish a recorded result from claims the registry does not establish.

18. 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 information and the reported comparison. The study's brief summary describes 128 breast cancer outpatients as the number to be randomized, whereas the record lists enrollment of 153 and the primary outcome includes 71 participants in each arm. The video arm has 73 participants in the retention and adverse-event counts, with 71 completing the primary measure. The registry does not explain the relationship among these counts, so they should not be reconciled by assumption.

The primary endpoint is self-reported confidence on a scale, not recorded communication behavior. The registry does not report an important-difference threshold, and it does not provide a direct mapping from the score to whether concerns were raised during a visit. The outcome is assessed at 2 weeks; the record does not establish how durable any change might be beyond that assessment.

Two participants in Resources + Video withdrew before the primary assessment. Reasons for withdrawal, missing-data handling, and sensitivity analyses are not reported. The statistical analysis plan, randomization implementation details, allocation concealment, and adjusted analyses are also not reported in the registry record. No conclusions about those procedures should be inferred from their absence in the record.

The trial is listed as unmasked. Because the intervention includes educational materials, participants would know whether they were asked to view the video, but the registry gives no further description of masking for outcome assessment or analysis. The reported comparison is unadjusted, and the record does not describe multiplicity control across the many outcomes. Secondary results therefore add context but should not be treated as confirmatory without qualification.

The intervention bundles a video and workbook with resources, limiting attribution to any single component. The comparator also receives resources, so the result is not a comparison with no intervention. Finally, generalizability cannot be assessed fully from the registry record because detailed participant characteristics, eligibility criteria, and recruitment information are not reported in the information summarized for this analysis.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study — NCT03624972.
• Registry record last updated 2021-03-16; status last verified 2021-03.
• Results first posted 2021-03-16.
• 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.

22. Record Summary

The registry record describes a completed randomized, parallel-group study of an educational video and resources intended to support communication about sexual-health concerns in breast cancer care. The patient comparison was Resources + Video versus Resources Only; clinicians formed a separate audio-recording arm with no outcomes data collected from clinician participants.

The primary endpoint was self-reported self-efficacy for communicating about sexual-health issues at 2 weeks, scored from 0-10. Mean scores were 8.8 and 8.5, respectively, with an unadjusted mean difference of 0.3, a 95% confidence interval from -0.343 to 0.943, and p = 0.361. The interval includes zero and leaves uncertainty about the direction and magnitude of the difference.

The record also lists secondary outcomes and reports zero serious adverse events, other adverse events, and deaths in the listed groups. The original sample-size justification, detailed statistical analysis plan, multiplicity handling, and missing-data methods are not reported in the registry record. The results should be interpreted as outcome-specific estimates rather than as a complete account of every design and analysis decision.