Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation (NCT05270395), a randomized na study. The primary outcome is Feasibility of Enrollment.

2. Clinical Question

3. Trial Design

NCT05270395 is a completed randomized, parallel-group pilot study of mPal, a behavioral implementation strategy for integrating non-hospice palliative care into advanced-stage lung cancer treatment. The registry lists an enrollment of 75 and identifies lung cancer as the condition. The study began on 2022-07-28, reached primary completion on 2024-03-22, and is marked completed. Its phase is listed as NA.

Participants were assigned to mPal intervention or standard of care. The registry describes the allocation as randomized and masking as none. It also states that participants were not randomized until they had completed baseline assessment. This timing matters when interpreting the primary endpoint: its description defines enrollment feasibility using eligible and approached patients who agreed to participate, and clarifies that the count is of total eligible individuals, rather than only those subsequently randomized.

The intervention description includes patient-facing web-based content, including a brief educational video intended to teach patients about palliative care and assessments related to palliative care knowledge. The available description ends before all components are specified. The comparator is described as standard of care for patients, but its specific content is not reported in the registry record.

The study was designed to assess feasibility and acceptability, rather than to establish a clinical treatment effect. The registry lists 16 outcome measures and 10 analyses, but detailed results and the analysis methods are not reported in the registry record. The posted primary endpoint is a count, not a measure of change or a time-to-event outcome. Although two randomized groups are described, the registry record indicates that a primary-outcome comparison was not available for analysis. The protocol, detailed recruitment procedures, allocation concealment, and any rationale for the planned enrollment 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: In this study, individuals were not randomized until they completed the baseline assessment. Although 75 participants were consented, only 68 completed baseline assessments and were randomized.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants were not randomized until they completed baseline assessment, thus, this number is the total individuals eligible.

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 of Enrollment, measured over up to 6 months.

The primary endpoint, “Feasibility of Enrollment,” is defined as the number of eligible and approached patients who agree to participate. Its stated timeframe is up to 6 months, and its unit is participants. The registry clarifies that randomization occurred only after baseline assessment, so this endpoint concerns the broader pool of eligible individuals, not just the randomized participants.

A recruitment count can help describe whether a study was able to enroll people from its intended population. In a pilot study, this kind of feasibility information can inform whether recruitment procedures are workable and whether a larger evaluation may be practical. The count alone does not describe why eligible people did or did not agree, how quickly recruitment proceeded, or whether participants represent the wider population of interest. Those details are not reported in the registry record.

The registry record does not report the observed enrollment-feasibility count or a prespecified criterion for judging it adequate. It therefore does not support a conclusion about whether the enrollment target or feasibility objective was met. The enrollment figure of 75 is listed for the study, but it is not the reported result for the primary endpoint: the endpoint is specifically defined by eligible and approached people who agreed to participate.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

Random assignment is intended to make the study groups comparable, on average, with respect to characteristics that could affect outcomes. It supports a fair comparison when outcomes are analyzed according to an appropriate plan and when follow-up and measurement are sufficiently complete. The registry describes the allocation as randomized, but does not report the sequence-generation method, allocation concealment, or the detailed analysis plan. Masking is listed as none, so the record does not describe a masked design.

Randomization took place after baseline assessment. That means the group comparison pertains to participants who reached the randomization stage, while the primary enrollment-feasibility endpoint is defined earlier in the recruitment process. These are distinct populations and questions: recruitment feasibility concerns eligible people approached for participation, whereas randomized comparisons concern participants assigned to a study group. The registry does not report a participant-flow account that would connect these stages.

How should a count endpoint be read?

The primary endpoint is a count of eligible, approached patients who agreed to participate. A count is a direct description of how many people met the endpoint definition, but its interpretation depends on the underlying recruitment process. For example, the count does not by itself show the proportion of eligible people who agreed, because the required denominator and the observed endpoint value are not reported. It also does not show how recruitment varied over time or across settings.

Counts are often analyzed using methods suited to count data. A simple count model may be inadequate if the variability in counts is greater than the model expects; this is called over-dispersion. General statistical practice is to assess whether the model’s assumptions fit the data and to use an approach that accounts for extra variability when needed. The registry does not report a count model, a dispersion assessment, or a model-based estimate for this endpoint. No particular model should therefore be attributed to this study.

What do estimates and confidence intervals convey?

An effect estimate describes the magnitude and direction of a comparison on a defined scale. A confidence interval describes the uncertainty around an estimate under the assumptions of the analysis. A wide interval indicates that a broad range of values remains compatible with the data and model; a narrow interval indicates greater precision. Neither an estimate nor its interval is reported for the primary endpoint or the listed secondary outcomes. The magnitude and precision of any group difference cannot be assessed from the registry information.

A p-value, when reported, is a measure of how compatible the observed data are with a specified null model and its assumptions. It is not a measure of the probability that an intervention is effective, and it does not convey the size or practical importance of an effect. The registry record does not report p-values for the outcomes discussed in this analysis.

What do the planning assumptions mean?

The record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. These are described as illustrations, not as the trial’s original design justification. The effect to detect is defined as a stated fraction of the observed effect. No sample-size justification for the trial is reported in the registry record, and no numeric planning results or observed effect estimate are available in the registry record described for this analysis.

Such planning calculations ask how many participants per arm would be needed under stated assumptions to detect a chosen effect with a specified power. They depend on the assumed effect, variability, allocation, significance level, and analysis method. They are not observed power and do not establish that a completed study had sufficient information to detect a meaningful effect. For this record, the missing outcome estimates prevent readers from independently assessing the observed effect or the precision of comparisons.

The record’s analysis count is 10, but the methods associated with those analyses are not reported in the registry record. It is not possible to identify which outcome models, covariates, estimands, or contrasts were used, or how any departures from assumptions were handled. The statistical concepts above are general explanations, not descriptions of an analysis confirmed for this trial.

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("Eligible Participants")
n      <- c(118)
events <- c(75)
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  Eligible Participants  118  75  63.6  54.2  72.2  54.6  71.7  54.6  71.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 16 outcome measures and 10 analyses. A study with multiple outcomes or analyses raises the general issue of multiplicity: the more questions examined, the greater the possibility that some findings may appear notable by chance if each is assessed separately. Statistical approaches can control or describe this issue, but the appropriate approach depends on which outcomes were prespecified as primary, how outcomes relate to one another, and the intended interpretation.

The record identifies “Feasibility of Enrollment” as the primary endpoint, while listing secondary outcomes related to referrals, acceptability, attitudes, feasibility, retention, and palliative care knowledge. A multiplicity adjustment, testing hierarchy, or other plan for interpreting results across outcomes is not reported in the registry record. Because outcome estimates and p-values are not reported, the extent to which multiplicity affects interpretation cannot be assessed.

Missing-data procedures and analysis populations are also not reported in the registry record. The record states that randomization followed baseline assessment, but it does not give the number of participants with outcome data, explain how incomplete assessments were handled, or specify whether analyses followed assigned group or another population definition. These details matter because exclusions and missing outcomes can affect both the groups represented in an analysis and the uncertainty of its estimates.

The enrollment total should not be taken as the denominator for every endpoint. The relevant denominators may differ by outcome and analysis, but those values are not reported in the registry record. No assumptions about missingness, imputation, or analysis-set membership can be made from the information available.

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 lists 34 participants at risk for serious adverse events in the mPal intervention group and 34 in the standard-of-care group. It reports zero participants with serious adverse events in each group. For other adverse events, the listed at-risk counts are also 34 in each group, with zero affected participants in both groups. Deaths are recorded separately: 1 in the mPal group and 2 in the standard-of-care group.

These are descriptive counts, not a comparative safety analysis. The registry does not report details about the deaths, event timing, causes, relationship to study participation, or how events were collected. It also does not provide uncertainty intervals or a statistical test. The adverse-event entries therefore cannot establish that the groups had equivalent safety, nor can the death counts be attributed to the intervention or comparator. The trial enrollment of 75 is not a substitute for the event-specific at-risk counts listed in the safety record.

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

The registry record describes a completed randomized pilot intended to assess whether mPal, a multilevel strategy with web-based patient content, could be implemented in advanced-stage lung cancer care and would be acceptable. It specifies a recruitment-focused primary endpoint and lists secondary measures concerning referrals, acceptability, feasibility, retention, attitudes, and knowledge. These stated aims clarify what the study set out to examine.

The record does not report the observed value for the primary endpoint, secondary outcome results, or comparative estimates. It therefore does not establish how many eligible and approached patients agreed to participate, whether recruitment met a feasibility criterion, whether palliative care referrals changed, or whether attitudes or knowledge changed. It also does not provide estimates with which to judge the size or precision of any group differences.

The random allocation and parallel design describe how a comparison was intended to be made, but design features alone are not outcome evidence. The registry indicates that a primary-outcome comparison was not available for analysis. Even with the posted adverse-event counts, the absence of event details and comparative analyses limits interpretation to the recorded counts; it does not support a conclusion about causation or equivalence.

Accordingly, the information in the registry record supports a description of the trial’s design, stated objectives, and selected safety counts. It does not support a conclusion that mPal did or did not improve palliative care use, or that it did or did not meet feasibility or acceptability goals. Such judgments would require reported outcome values, denominators, analysis methods, and uncertainty estimates. No medical advice or treatment conclusion follows from the information recorded.

14. Why This Trial Matters Statistically

Feasibility studies address whether a research strategy can be carried out and evaluated in a real clinical context. That is a distinct statistical question from whether an intervention changes a clinical outcome. For mPal, the primary endpoint is explicitly recruitment-oriented: it counts eligible, approached patients who agreed to participate. Keeping that endpoint distinct from clinical outcomes helps prevent a recruitment count from being misread as evidence about palliative care use or patient benefit.

The registry also illustrates why the timing and denominator of an endpoint matter. Baseline assessment preceded randomization, while the primary feasibility definition refers to eligible and approached people. The recruitment count and the randomized comparison therefore concern different stages of study participation. Without a reported participant flow and endpoint value, readers cannot reconstruct how people moved from eligibility to consent, baseline assessment, randomization, and outcome assessment.

Another statistical issue is the gap between a stated design and an interpretable result. Randomization offers a framework for comparison, but comparative interpretation still requires outcome data, effect estimates, and measures of uncertainty. The record lists 16 outcome measures and 10 analyses, yet does not report the detailed estimates or analysis methods. This makes it particularly important to distinguish what was planned and measured from what the posted evidence can demonstrate.

Finally, pilot results are most useful when their scope is clear. Feasibility and acceptability measures can guide decisions about study procedures, while evidence about clinical outcomes requires appropriately reported comparative data. The registry record identifies the former as a central purpose but does not include the results needed to judge them. This is a limitation of what can be concluded from the posted record, not a basis for assuming an unreported result.

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 most important limitation for interpreting this trial from the registry record is the absence of reported primary and secondary outcome values. The primary endpoint is defined, but its observed count is not reported, and no feasibility threshold is stated. The secondary outcomes are named without estimates, denominators, or comparative results. As a result, neither the study’s recruitment performance nor the intervention’s measured outcomes can be evaluated quantitatively from the record.

Details needed to understand the study population and implementation are also limited. The registry gives advanced-stage lung cancer as the intended population in its study description, but further eligibility criteria and recruitment-setting details are not reported. The description of the intervention identifies some web-based content but does not give the full set of components or implementation procedures. Standard of care is named as the comparator without further description.

Statistical reporting is insufficient to assess the planned or performed analyses. Although 10 analyses are listed, the analysis methods, estimands, model assumptions, adjustment variables, and treatment of missing data are not reported. The record does not specify analysis populations or explain whether outcomes were evaluated according to randomized assignment. It also does not report a multiplicity plan despite listing 16 outcome measures.

Safety information is limited to event counts and at-risk counts. The record does not provide event descriptions, timing, relatedness, or comparative uncertainty. The enrollment total of 75 should not be assumed to be the denominator for every outcome, and the record does not provide enough participant-flow detail to reconcile the enrollment figure with the safety at-risk counts.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation — NCT05270395.
• Registry record last updated 2025-05-13; status last verified 2025-04.
• Results first posted 2025-05-13.
• 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

NCT05270395 is a completed randomized, parallel-group pilot with no masking, comparing mPal with standard of care. The registry lists enrollment of 75, lung cancer as the condition, and a study period from 2022-07-28 to primary completion on 2024-03-22. The stated purpose was to assess the feasibility and acceptability of mPal for supporting palliative care use among people with advanced-stage lung cancer receiving cancer treatment.

The primary endpoint is the count of eligible and approached patients who agreed to participate, within a timeframe of up to 6 months. The registry lists 16 outcome measures and 10 analyses but does not report the primary endpoint result or comparative estimates. Safety entries list zero serious adverse events and zero other adverse events among 34 at risk in each group, with deaths recorded as 1 and 2, respectively. Event details and statistical comparisons are not reported in the registry record.