Empowering LGBTQ+ Tobacco Cessation Pilot: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Empowering LGBTQ+ Tobacco Cessation Pilot (NCT05365633), a na na study. The primary outcome is Retention.

2. Clinical Question

The study also aimed to assess acceptability, feasibility, and preliminary impact. Listed secondary outcomes include self-reported 7-day point prevalence abstinence at Week 12, biochemical verification of self-reported smoking abstinence, and reported change in adaptive coping from baseline to exit. The registry record does not report results for these outcomes.

3. Trial Design

This completed pilot enrolled a planned 20 sexual and/or gender minority adults in Oklahoma who smoked and were willing to quit. It used a single-group intervention design. The intervention combined standard tobacco cessation assistance through the Stephenson Cancer Center Tobacco Treatment Research Program with empowerment activities, described as SGM organizing and community-building. Examples included conducting follow-up phone calls to name change clinic participants. An Oklahoman SGM-serving community partner was to guide the activities.

The design has no separate control arm, and the registry lists allocation as not applicable and masking as none. Consequently, the record does not describe a randomized comparison or a like-for-like control group. Changes during the study cannot be separated from the intervention's effects using a concurrent control comparison. The registry describes the purpose as assessing feasibility and acceptability alongside preliminary impact, rather than establishing a comparative treatment effect.

Participants were to complete 8 surveys during the intervention period and 12 weeks post-quit-date, as well as a 60-minute in-depth exit interview. The registry's primary outcome focuses on completion of the final study visit at 12-weeks post-quit. The posted record does not report how many participants completed that visit, nor does it give results for the surveys or interviews.

The record lists the study as completed and identifies University of Oklahoma as sponsor. It does not report a detailed protocol for allocation, masking, or a control condition. No study-specific statistical analysis entries are listed in the registry record. Details of any analyses conducted outside the record are 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.

Before assignment: 20 participants signed consent, were fully enrolled, and were randomized to the intervention.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Treatment group in a single-arm pilot trial

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 Retention, measured over 12-weeks post-quit.

The primary endpoint is retention, defined in the registry as the proportion of participants who complete the final study visit at 12-weeks post-quit. The record states a goal of retaining >80% of participants. This is a study-process measure: it describes whether participants remain engaged through the planned final visit, rather than measuring smoking abstinence or a comparative treatment effect.

Retention is useful in a pilot because it helps assess whether the study procedures and follow-up schedule can be carried through with the intended population. A high completion proportion can indicate that follow-up was achievable for the enrolled group, while a lower proportion would raise questions about whether the procedures need adjustment. Those interpretations depend on the observed completion data and any account of why participants did or did not complete follow-up. Neither the observed retention proportion nor reasons for non-completion are reported in the registry record.

The endpoint is expressed as a proportion, but the registry does not report the numerator, denominator used for the final calculation, or an uncertainty interval. Enrollment is listed as 20, but that alone does not establish how many participants reached the final visit or which participants were included in any analysis. The posted record therefore describes what retention was intended to measure and the stated goal, but does not permit assessment of whether the goal was met or how precisely retention was estimated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is registered as a single-group pilot. This means the intervention was delivered to one study group, without a separately listed control group. In general, a single-group study can describe participant experience and outcomes over time, but it does not provide the direct between-group comparison available in a controlled design. Changes may coincide with the intervention without being attributable to it alone. In this study, standard cessation assistance and empowerment activities were delivered together, so their individual contributions cannot be separated by the registered design.

What does a retention proportion represent?

A proportion relates the participants who meet a specified condition to the participants included in its denominator. Here, the condition is completing the final study visit at 12-weeks post-quit. The registry describes retention as a proportion and states a goal of >80%. To interpret an observed proportion, readers would need the completion count and the denominator used for the calculation. The record does not report those values or an observed proportion, so the target cannot be evaluated from the registered results.

In general, a confidence interval describes the range of estimates reasonably compatible with the observed data under a statistical method and its assumptions. It conveys uncertainty around an estimate; it does not guarantee that the true value lies within the interval. The registry record does not report a confidence interval for retention or for the listed secondary outcomes. Without an estimate and interval, neither the size nor the precision of an observed outcome can be assessed from this record.

How should the binary outcomes be understood?

The listed abstinence outcomes are framed as participant counts: self-reported 7-day point prevalence abstinence at Week 12 and participants for whom self-reported abstinence is biochemically verified. In general, a binary outcome classifies each participant according to whether a defined event or condition is present. Counts can be converted to proportions when the relevant denominator is known. The registry does not report the outcome counts, denominators, or analysis results, so no abstinence proportion can be interpreted from the record.

Biochemical verification is listed as a separate outcome from self-report. These measures address different aspects of outcome assessment: self-report records participants' reports, while verification records whether the reported abstinence was confirmed biochemically. The registry excerpt does not describe the verification procedure or report how often verification was obtained. Those details are not reported in the registry record.

What do the planning assumptions tell readers?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. These are planning assumptions for an illustration, not the registered study's single-group allocation scheme. The record does not report a study-specific statistical analysis plan or numerical planning results in the registry record for interpretation.

In general, a sample-size illustration estimates how many participants might be needed under specified assumptions to detect an effect using a chosen statistical procedure. Its result depends on the assumed effect, variability, significance level, allocation, and analysis method. Such an illustration is not observed power and does not show that the completed study had a particular probability of detecting an effect. Here, the stated two-arm allocation assumption does not match the single-group design, so it should not be treated as a description of how participants were assigned in the trial.

For count outcomes, the observed event count and the population at risk provide the basic descriptive information. Statistical interpretation may also depend on whether observations are independent and whether the model's assumptions fit the data. These are general considerations; the registry does not report a model, a dispersion assessment, or analysis results for this study. No new effect estimate or uncertainty measure can be reconstructed from the registered information.

What is not available about the analysis?

The registry lists 9 outcome measures and 0 analysis entries. It does not report the statistical methods used for the primary or secondary outcomes, whether any adjustments were made, or the treatment of incomplete observations. It also does not report an interim analysis plan. These details should not be inferred from the stated endpoints or the planning illustration. Without outcome data and analysis methods, statistical significance, precision, and the robustness of any outcome estimate cannot be assessed.

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("Empowerment Activity-enhanced Tobacco Cessation As")
n      <- c(20)
events <- c(16)
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  Empowerment Activity-enhanced Tobacco Cessation As  20  16  80.0  56.3  94.3  58.4  91.9  58.1  91.8

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 9 outcome measures and names several secondary outcomes, including self-reported 7-day point prevalence abstinence at Week 12, biochemical verification of self-reported smoking abstinence, and reported increase in adaptive coping from baseline to exit. It identifies retention as the primary outcome. The record does not report how results across these outcomes were analyzed or whether any adjustment for multiple testing was planned or used.

In general, multiplicity arises when researchers examine several outcomes or make several statistical comparisons. If each is assessed separately, the chance of finding at least one apparently notable result can increase. Methods for controlling that issue depend on the analysis plan and the purpose of the outcomes. No multiplicity procedure is reported in the registry record, so it is not possible to determine how the study addressed this general concern.

The registry does not describe the handling of missing survey responses, missed visits, or unavailable biochemical verification. It also does not report whether the primary outcome denominator included all enrolled participants or a subset with available follow-up. These choices can affect interpretation of retention and the listed secondary outcomes. No assumptions about missingness or imputation should be inferred from the endpoint definitions.

The record lists no analysis entries, and it does not identify an analysis population for the outcomes. The registry therefore does not establish whether analyses used all enrolled participants, only participants with complete data, or another defined group. The impact of missing data, multiplicity, and analysis-population choices is not reported in the registry record.

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 safety record lists 20 participants at risk in the intervention group. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths for that group. These are the counts recorded for the group; they are not comparative estimates, because the study has no separate control group.

A count of 0 means that no events in that category are recorded in the posted safety results for the group. It does not establish that the risk of such events is absent, and it does not show how the result would compare with another intervention or with no intervention. In general, safety counts are interpreted in relation to the number of participants observed, the duration and completeness of safety follow-up, and how events were defined and collected. The registry record does not report those details.

The listed figures should also be kept distinct from the primary endpoint. Retention measures completion of the final visit, whereas adverse-event counts describe safety events recorded during the study. The registry does not provide an event-level account or further detail about ascertainment. The posted counts therefore provide a limited descriptive safety summary, not a comprehensive estimate of safety or a comparison of risks.

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

The registry record describes an intervention that paired standard tobacco cessation assistance with empowerment activities for SGM adults who smoked and were willing to quit. It identifies feasibility, acceptability, and preliminary impact as study aims, with retention at 12-weeks post-quit as the primary outcome. This information clarifies the study's purpose and intervention, but the registered record does not report the observed primary or secondary outcome results.

The record does not report whether participants completed the final visit at the stated target rate, how many reported abstinence, how many reports were biochemically verified, or whether adaptive coping increased. It therefore does not show that the intervention achieved any of these outcomes, nor does it show that it failed to do so. An outcome that is not reported cannot be interpreted as a result of no change.

Even if outcome estimates were available, the single-group design would constrain causal interpretation. Without a concurrent comparison group, changes could not be distinguished from changes that might have occurred over time for other reasons. Because cessation assistance and empowerment activities were combined, the design would also not identify the independent contribution of either component. The pilot can be relevant to questions about procedures and participant follow-up, but the registry record alone cannot establish comparative effectiveness.

The posted safety figures record 0 serious adverse events, 0 other adverse events, and 0 deaths among 20 participants at risk in the intervention group. These counts describe the registry's safety entries, not a guarantee of no risk or a comparison against another group.

The appropriate conclusion is limited: the record describes a completed single-group pilot and its intended measures, but does not provide results adequate to estimate retention, abstinence, coping change, or their statistical precision. Further outcome details are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically interesting because it tests an approach that combines individual cessation assistance with community-oriented empowerment activities in a population identified in the registry as sexual and/or gender minority adults. Its stated aims include feasibility and acceptability as well as preliminary impact. In a pilot context, whether participants can be recruited, take part in study procedures, and complete follow-up can be informative alongside clinical outcome measures.

Retention is the primary endpoint, which places attention on follow-up completion rather than treating abstinence as the only relevant measure. The registry defines retention around completion of the final study visit at 12-weeks post-quit and states a goal of retaining >80% of participants. That framing makes the endpoint directly relevant to the practicality of conducting follow-up, but the record does not report the observed completion result, so the goal cannot be assessed.

The intervention also raises a design question: standard cessation assistance and empowerment activities are delivered together. The pilot's single-group design can describe outcomes for participants receiving the combined approach, but it cannot compare that approach with standard assistance alone or isolate the contribution of the empowerment activities. This distinction matters when interpreting any eventual preliminary outcome estimates.

Statistically, the record demonstrates why a clearly stated endpoint is not a substitute for a reported estimate and its uncertainty. Without outcome counts, denominators, analysis methods, and follow-up details, readers cannot judge the precision or interpret the magnitude of an observed effect. The study's aims and design are described, but the registered record does not contain the analyses needed to evaluate its measured outcomes.

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.

The central limitation for interpreting this trial from the registry record is the absence of reported outcome results. The record describes retention as the primary endpoint and lists secondary outcomes, but does not provide the observed retention proportion, abstinence counts, biochemical verification results, or coping-change findings. It also does not provide confidence intervals, p-values, or other measures of uncertainty.

The single-group design has no concurrent control comparison. As a result, the record cannot support a controlled estimate of the intervention's effect relative to another approach. The combination of standard cessation assistance and empowerment activities also prevents the separate effects of those components from being identified within this design.

Important analysis details are not reported in the registry record, including the denominator used for retention, the treatment of missing visits or survey data, and the analysis populations. The record also does not describe how biochemical verification was conducted, how acceptability and feasibility were assessed, or how qualitative exit interviews were analyzed. These omissions limit assessment of both outcome definitions and the completeness of follow-up.

The planning illustration is described using assumptions for equal allocation between two arms, while the registered trial is single-group. It should therefore be distinguished from the design actually registered. The record does not list study-specific analysis entries or report whether the illustration informed the trial's design. These limitations mean the available registry information is insufficient to evaluate the observed statistical performance or make claims about the intervention's impact.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Empowering LGBTQ+ Tobacco Cessation Pilot — NCT05365633.
• Registry record last updated 2025-05-15; status last verified 2025-04.
• Results first posted 2025-05-15.
• 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 record describes a completed, single-group pilot sponsored by University of Oklahoma. It planned to enroll 20 SGM adults in Oklahoma who smoked and were willing to quit. Participants were to receive standard tobacco cessation assistance through the Stephenson Cancer Center Tobacco Treatment Research Program alongside SGM organizing and community-building activities guided by an Oklahoman SGM-serving community partner.

The primary outcome is retention, defined as completion of the final study visit at 12-weeks post-quit, with a stated goal of retaining >80% of participants. Listed secondary outcomes concern self-reported abstinence, biochemical verification, and adaptive coping. The record reports no outcome analyses or observed results for these measures.

The safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths among 20 participants at risk. The registered design has no separate control group, and statistical analysis, missing-data, and analysis-population details are not reported in the registry record.