LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer (NCT06464562), a na na study. The primary outcome is Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires.

2. Clinical Question

LiveWell examines an adapted Dialectical Behavioral Therapy Skills Training protocol for people living with metastatic lung cancer. Its primary question is whether participants complete the study questionnaires, a measure the registry labels as usability. The registry lists one participant enrolled and sets the primary outcome timeframe as up to 8 weeks, but it does not report the number who completed the questionnaires.

This is a question about whether the questionnaire-completion measure was achieved in this study, not a comparison of LiveWell with another intervention. Without a reported completion count, the primary question cannot be answered from the registry record.

3. Trial Design

The registry describes LiveWell as a completed, single-group behavioral study sponsored by Duke University. Its title identifies an adaptation of DBT Skills Training for metastatic lung cancer. The study is listed as phase NA, with allocation NA and masking set to none. The enrollment field reports one participant.

The intervention description characterizes LiveWell as an 8-session skills-training protocol adapted specifically for patients with metastatic lung cancer. The brief summary says sessions are delivered one-on-one by videoconference. It describes the intervention as teaching skills related to mindfulness, distress tolerance, emotion regulation, and interpersonal effectiveness. These details describe the intended intervention; the record does not report how many sessions the enrolled participant attended or completed.

The study began on 2025-02-14, reached primary completion on 2025-07-07, and is listed as completed. The primary outcome timeframe is up to 8 weeks. These dates and status describe the registry record, but do not establish when any individual completed questionnaires or the intervention.

A single-group design can describe what was observed among participants exposed to an intervention, but it does not supply a concurrent control group for estimating a between-group effect. The registry also reports no analyses. Thus, the record supports a description of study design and recorded counts, but not a comparative estimate of intervention effects. The registry does not report further protocol details, including whether any additional study procedures were used beyond those described.

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 Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires, measured over Up to 8 weeks.

The primary endpoint is the total number of participants who complete the study questionnaires, with the outcome expressed in participants and assessed over up to 8 weeks. The registry labels this outcome as usability. A completion count can indicate whether participants reached a specified questionnaire-completion milestone; it does not, by itself, describe questionnaire scores, symptom change, intervention benefit, or participants’ reasons for completing or not completing the questionnaires.

In general, a completion measure is useful in an intervention-development study because it can show whether the planned assessment process was carried through by participants. Its interpretation depends on a clear definition of what counts as completion, which questionnaires are included, and how missing or partially completed forms are handled. Those operational details are not reported in the registry record.

The registry reports one participant enrolled but does not report the primary endpoint result. Consequently, the completion count, the number of participants who did not complete questionnaires, and any uncertainty around the completion proportion are not reported in the registry record. Enrollment alone cannot be treated as questionnaire completion. The endpoint therefore identifies what the study intended to measure, but the posted results do not establish the observed usability outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study’s reported design and available results call for a distinction between descriptive counts and inferential comparisons. The registry lists a single-group model, no masking, allocation NA, and one participant enrolled. It reports no analyses. The primary outcome is a count of participants completing questionnaires, but its observed value is not reported in the registry record.

What can a single-group count show?

In general, a count records how many observations meet a defined condition. For this endpoint, the condition is completion of study questionnaires. To interpret such a count, readers need the completion definition and the relevant population at risk for completing the assessment. A count alone does not establish a rate unless its denominator is clear, and it does not provide a comparison with what might have happened under another intervention or usual care.

The registry identifies enrollment as one participant, but does not report the endpoint count or operational details about completion. It is therefore not possible to infer the endpoint result from enrollment. The record also does not state whether partial questionnaire completion was treated as completion, what happened to missing items, or whether any assessments were not due for a participant.

Why is a comparator important?

In general, a randomized controlled comparison can help distinguish an intervention-associated difference from changes that might also occur without the intervention. A single-group design has no concurrent comparison group. It can describe what happened during the study, but it cannot isolate the intervention’s causal effect from other explanations. Here, the registry’s design fields identify a single group and no comparator. Although the arm description contains wording about randomization, the overall record does not describe a randomized comparison, and no comparison analysis is reported.

Masking is recorded as none. In general, masking can reduce the influence of expectations on some aspects of study conduct or assessment, depending on who is masked and how outcomes are measured. The record does not report a masking procedure. For a questionnaire-completion count, the principal missing information remains the actual endpoint result and how completion was defined.

What do significance tests and confidence intervals mean?

In general, a significance test evaluates how compatible observed data are with a specified null hypothesis under stated assumptions. A p-value is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. A confidence interval describes a range of estimates compatible with the data and method at a stated confidence level; its width conveys precision. Both tools require an estimand, data, and an analysis model. The registry reports no inferential analyses, p-values, or confidence intervals for this study, so there is no such result to interpret.

For a binary or count outcome, an analysis might describe the number meeting a criterion and, when appropriate, an estimate of the underlying probability. Such estimates are sensitive to the number of observations and the definition of the analysis population. No completion result or analysis population is reported. No new estimate can be derived from the enrollment count alone.

How should planning assumptions be read?

In general, sample-size calculations are planning tools that describe the amount of information a hypothetical design might require under specified assumptions. The registry’s stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a fraction of an observed effect. Those assumptions describe a planning illustration, not the study’s observed analysis. They do not change the registry’s single-group design, and the record does not report a two-arm comparison or an inferential result.

A planning calculation based on an observed effect should not be confused with observed power. Observed power is not a substitute for reporting the estimate and its uncertainty. Sample-size illustrations are conditional on their assumptions and cannot repair the absence of a reported endpoint result or create a comparator. The record does not report a protocol-based sample-size justification or explain how the planning assumptions relate to the completed single-group study.

Why can over-dispersion matter in general?

For count data, some statistical models assume that variability follows a specified relationship to the average count. Over-dispersion means that the observed variability exceeds what that model expects. If ignored, uncertainty estimates can be too small and tests can appear more decisive than warranted. This is a general issue for count-data methods; the registry record does not report a model, dispersion estimate, or count analysis for this outcome.

The most defensible statistical reading is therefore descriptive: the record documents the intended endpoint and study structure, but does not report the primary endpoint result or an analysis. General statistical methods can clarify what an analysis would require, but they cannot supply the missing result.

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("LiveWell: Adapted Dialectical Behavioral Therapy S")
n      <- c(1)
events <- c(1)
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  LiveWell: Adapted Dialectical Behavioral Therapy S  1  1  100.0  2.5  100.0  20.7  100.0  15.8  98.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure and reports no analyses. It does not report a multiplicity plan, such as how inference would be handled across multiple outcomes, time points, or statistical tests. Because no inferential results are reported, there are no reported p-values to assess for multiplicity. The absence of a listed plan should not be interpreted as evidence that a particular adjustment was or was not used outside the registry record.

The primary measure concerns participants completing study questionnaires, but the record does not define completion operationally or report the observed completion count. It also does not describe how partially completed questionnaires, missing items, missed assessments, or withdrawals were handled. The timing of questionnaire administration within the stated timeframe is not reported. As a result, it is not possible to assess whether missing data affected the endpoint or how the endpoint population was determined.

The record does not identify an analysis population, such as all enrolled participants or a subset with available questionnaire data. With a single-group design and no reported analysis, there is no basis to determine which participants were included in a statistical analysis. No imputation method, sensitivity analysis, or missing-data assumption is reported in the registry record.

These omissions matter because a completion count depends on both the definition of completion and the population being counted. Missingness can also be informative: participants who do not complete questionnaires may differ from those who do. In general, an analysis should make these definitions and assumptions explicit. Here, the endpoint result, missing-data handling, and analysis population are not reported in the registry record, limiting interpretation of the intended usability measure.

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 safety entry lists one participant at risk for serious adverse events, with zero affected. It lists one participant at risk for other adverse events, with zero affected, and records zero deaths. These are the posted counts for the study. They do not describe a comparison with another group.

In general, an adverse-event count is a record of events meeting a study’s reporting definitions; it does not by itself establish whether an event was caused by an intervention. The registry record does not report further details about event definitions, severity beyond the serious-versus-other categories, attribution, timing, or the safety observation period. The primary outcome timeframe of up to 8 weeks should not be assumed to define the safety observation period.

Zero affected participants in the posted counts is not evidence that risk is absent. With one participant at risk in each listed category, the counts provide very limited information about how often events might occur in a broader population. They also cannot support a comparative safety conclusion. The record reports no deaths, but the safety information remains descriptive and limited to the posted counts.

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

The registry record establishes that LiveWell was registered as a completed, single-group study of an adapted DBT Skills Training protocol for metastatic lung cancer. It reports one participant enrolled and defines the primary outcome as the total number completing study questionnaires within up to 8 weeks. It does not report the primary outcome result. The central usability question therefore remains unanswered by the posted results.

The record also reports zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths in the listed safety data. These are observed registry counts, not estimates of risk for a wider population. They do not show that an intervention is free of risk, and they cannot be compared with a control condition because none is reported.

The available information does not demonstrate that LiveWell improves symptoms, quality of life, or any other clinical outcome. Those outcomes are discussed in the study background, but no clinical-effect results or analyses are reported in the registry record. Conversely, the absence of reported effects does not show that the intervention has no effect. The necessary outcome estimates are not reported.

In general, a small single-group study can contribute descriptive information about an intervention and its assessment procedures. It cannot by itself establish causal effects or show how results would generalize to a broader patient population. In this case, even the primary descriptive completion result is not reported. The title, intervention description, status, and safety counts should therefore be kept separate from claims about effectiveness, acceptability, or feasibility.

The appropriate conclusion is limited: the registry describes a completed study with one participant enrolled and specifies questionnaire completion as the primary outcome, but does not report the outcome result or statistical analyses. Any interpretation beyond these recorded details would require information not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically important as an example of the difference between an outcome being specified and an outcome being reported. The registry identifies questionnaire completion as the primary usability measure, which makes the intended question clear. Yet without the observed completion count, readers cannot evaluate that question. A clearly named endpoint does not substitute for its result.

The single-group design also defines what kinds of conclusions are possible. Descriptive observations can characterize what was recorded in a study, while a comparative design is needed to estimate a difference between intervention conditions. The registry reports no comparator and no analyses, so the record does not support an intervention-effect estimate. This distinction helps prevent an intervention description or completed status from being mistaken for evidence of benefit.

The study’s very limited enrollment makes transparent reporting especially important. A count from one participant offers little information about how outcomes would vary in a broader group. Reporting the endpoint definition, the number assessed, missing-data handling, and uncertainty would help readers understand exactly what the study establishes. Those details are not reported in the registry record.

The safety counts illustrate a related point: zero recorded events in a small study is a description of the observed record, not proof of no risk. Statistical interpretation depends on the amount and quality of information, not only on whether a count is zero.

Finally, planning assumptions and observed results answer different questions. A sample-size illustration describes a hypothetical design under stated assumptions; it cannot replace the study’s actual outcome data or turn a single-group study into a controlled comparison. Distinguishing design, planning, and observed evidence is essential when interpreting this registry record.

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 registry record does not report the primary questionnaire-completion result, despite identifying it as the primary outcome. It also does not define what qualifies as completion, specify the questionnaires involved, or explain how partial responses were treated. This prevents a direct assessment of the stated usability measure.

Enrollment is reported as one participant, and the study is listed as single-group. The record does not describe a comparator or report an analysis. These features sharply limit what can be inferred about intervention effects or outcomes beyond the enrolled participant. The registry’s intervention-arm wording refers to randomization, while the design fields identify allocation as NA and the study model as single-group. The record does not clarify this wording, so it should not be read as evidence of a randomized comparison.

Information about participant characteristics, eligibility criteria, intervention attendance, adherence, and questionnaire timing is not reported in the registry record. The primary outcome timeframe is up to 8 weeks, but the individual assessment schedule is not stated. The record also does not describe an analysis population, missing-data methods, or a statistical analysis plan.

Safety reporting is limited to the posted at-risk and affected counts and deaths. The registry does not report event definitions, attribution, timing, or a safety observation period. The counts therefore cannot be used to estimate comparative risk or to make broad safety claims.

The study is listed as completed, but that status does not resolve the missing outcome information. Without the primary result, analysis details, or fuller participant-level context, the findings have limited interpretability and cannot establish effectiveness, generalizability, or the broader usability of LiveWell.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer — NCT06464562.
• Registry record last updated 2026-02-12; status last verified 2026-01.
• Results first posted 2026-02-12.
• 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

LiveWell is a completed, single-group study of an adapted DBT Skills Training protocol for metastatic lung cancer, sponsored by Duke University. The registry lists one participant enrolled, no masking, and allocation as NA. The study began on 2025-02-14 and reached primary completion on 2025-07-07.

The primary outcome is the total number of participants completing study questionnaires within up to 8 weeks. The completion result and statistical analyses are not reported in the registry record. The safety entry lists zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths. No comparator is listed, so the record does not provide a comparative treatment-effect estimate.