Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer (NCT05564468), a randomized na study. The primary outcome is Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial sponsored by Fred Hutchinson Cancer Center. It lists the phase as NA, an enrollment of 100, and a completed status. The listed study start is 2024-05-21 and the primary completion date is 2025-11-26. These registry entries describe the study record; they do not establish how many participants contributed data to each outcome.

Participants were assigned to Group I, Peacefully’s, or Group II, standard of care. Group I received the web-based tool on day 7, while Group II received standard care. The registry also lists best practice, an internet-based intervention, and questionnaire administration among the interventions. It does not explain in detail how those categories relate to the delivery of the two groups’ care, or specify which participants, clinicians, or assessors were masked.

The primary outcome was measured at baseline and week 4 post-randomization. The primary arm summaries contain 23 participants in Group I and 24 in Group II. These outcome counts are not the same as the enrollment listed for the trial, but the record does not explain the difference. The number randomized, the number who completed each follow-up, and the analysis population are not reported in the registry record.

The registry lists secondary outcomes at several follow-up times, including weeks 4, 12, and 24 for some measures. Numerical comparison records are available for selected week-4 secondary outcomes, but the record does not give results for every listed measure and timepoint. The planned statistical analysis, original sample-size justification, handling of missing data, and interim-analysis arrangements 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: Of the n=100 enrolled participants, n=29 were lost to follow up after consent but prior to completing the baseline study assessments, when randomization occurred.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization, measured over Baseline and Week 4 post-randomization.

The primary endpoint is change from baseline to four weeks after randomization in comprehensive end-of-life planning. It uses a 14-item checklist of completed tasks from the website, with examples including gathering important documents and creating a will. The score is the total number of completed planning items. Scores can range from 0 to 14, and higher scores indicate that more tasks have been completed. The change score can range from -14 to +14.

This endpoint is used to represent an observable aspect of planning: completion of listed tasks. That makes it distinct from an outcome based on a person’s feelings, knowledge, or conversations. A checklist score can describe whether recorded tasks were completed, but it cannot by itself establish the quality or suitability of those decisions, whether a task was completed outside the website, or whether planning reduced distress. Those broader outcomes are not captured by the primary score as defined in the registry.

The primary result compares the mean change scores between groups. The posted means are 1.57 for Group I and 0.04 for Group II, with a mean difference of 1.53. The registry describes the endpoint as a mean with standard deviation. It does not report a different primary measurement approach or a clinically meaningful threshold for interpreting a score difference.

7. Results Posted in the Registry

• Group I (Peacefully's): mean 1.57 versus 0.04 on control; difference 1.53 (95% CI 0.40 to 2.66), standardized effect d = 0.78; z-test p = 0.008.

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.

Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 4 Weeks Post-randomization

• 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:
  • Group I (Peacefully's): mean 0.26 versus 0.13 on control; difference 0.13 (95% CI -0.35 to 0.61), standardized effect d = 0.16; z-test p = 0.592.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Group I (Peacefully's) and the control. The interval gives the range of effects that remain compatible with the data.

Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 4 Weeks Post-randomization

• 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:
  • Group I (Peacefully's): mean 0.26 versus 0.75 on control; difference -0.49 (95% CI -1.13 to 0.15), standardized effect d = -0.44; z-test p = 0.136.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Group I (Peacefully's) and the control. The interval gives the range of effects that remain compatible with the data.

Change in Advance Care Planning Engagement: Conversations Discussing EoL Care, Living Will, HCP, and DNR Orders With Family Members/Loved Ones and Doctors, From Baseline to 4 Weeks Post-randomization

• 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:
  • Group I (Peacefully's): mean 1.22 versus 0.29 on control; difference 0.93 (95% CI 0.04 to 1.82), standardized effect d = 0.60; z-test p = 0.040.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Group I (Peacefully's) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes cover several aspects of advance care planning, including engagement measures and conversations about end-of-life care and related documents. Across the numerical week-4 comparisons, the direction and apparent strength of the estimates are not uniform. Some estimates favor the intervention group, while another points in the opposite direction; the uncertainty also varies. This mixed pattern is not a single consistent secondary signal.

The primary endpoint is a count of completed planning tasks. Secondary measures address related but distinct aspects of engagement and communication, so they can provide context without measuring the same construct. A pattern across these outcomes might help describe whether the observed primary difference is accompanied by changes in other planning activities. It does not establish that the checklist result generalizes to every dimension of planning or to later follow-up.

The record lists a broad set of secondary outcomes and timepoints, while numerical comparison records are available for selected outcomes. A full account of the results for every listed measure and timepoint is not reported in the registry record. The registry also does not report how the secondary analyses were prioritized or whether a particular subset was designated as confirmatory.

Unadjusted secondary results carry less weight because examining many outcomes can increase the chance of apparently notable findings arising by chance. The registry gives unadjusted p-values for the comparison records, and a multiplicity adjustment is not reported. That does not make the secondary data uninformative, but it means isolated results should be interpreted cautiously and alongside the overall pattern, rather than treated as independent confirmation of the primary result.

Secondary outcomes can be useful for forming hypotheses and identifying measurements that merit further study. Stronger confirmation would require a clearly described analysis plan, attention to multiple testing, and complete reporting across the outcomes and timepoints. Those elements are not reported in the registry record, so the secondary findings remain supportive context rather than a basis for a definitive broader conclusion.

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

• Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 4 Weeks Post-randomization
• Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 12 Weeks Post-randomization
• Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 24 Weeks Post-randomization
• Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 4 Weeks Post-randomization
• Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 12 Weeks Post-randomization
• Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 24 Weeks Post-randomization
• Change in Advance Care Planning Engagement: Conversations Discussing EoL Care, Living Will, HCP, and DNR Orders With Family Members/Loved Ones and Doctors, From Baseline to 4 Weeks Post-randomization
• Change in Advance Care Planning Engagement: Conversations Discussing EoL Care, Living Will, HCP, and DNR Orders With Family Members/Loved Ones and Doctors, From Baseline to 12 Weeks Post-randomization

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant’s change is represented by a numeric checklist score. For a continuous measure, an arm mean describes the average observed score change in that group. The standard deviation describes the spread of individual scores around the mean. In the primary summaries, Group I has a mean of 1.57 and standard deviation of 2.17; Group II has a mean of 0.04 and standard deviation of 1.76. Those figures describe the observed groups, not every participant who may have been randomized.

What does the mean difference represent?

The mean difference compares the average change in one group with the average change in the other. The posted unadjusted comparison is 1.53 points for Group I relative to Group II. A positive value means the Group I mean change was higher. Because this score counts completed tasks, the difference is expressed in checklist-score points. It should not be translated into an effect on distress or another outcome that the score does not measure.

The comparison record also gives a pooled standard deviation of 1.971 and a standardized effect size of 0.776. A standardized effect expresses a difference relative to the variability of the measure, allowing a scale-specific difference to be viewed in relation to score spread. It is a supplementary description, not a separate clinical outcome. The registry does not report a threshold for judging what size of checklist difference is important to participants.

How should the interval be understood?

A confidence interval expresses uncertainty around an estimated effect. In general, an interval procedure is designed to produce ranges that cover the true value at a specified rate over repeated applications when its assumptions hold. The primary comparison interval runs from 0.398 to 2.662. The confidence level for this interval is not reported in the registry record, so it should not be assigned a particular coverage label from this record alone. The interval’s width also matters: values across a range remain compatible with the data and calculation, rather than the estimate being known exactly.

The interval concerns the mean difference under the unadjusted calculation. It does not account for every possible uncertainty about trial conduct or outcome reporting. For example, the registry does not report the analysis population or the handling of missing outcome values. An interval cannot correct for selection or analysis choices that are not described.

What does the p-value add?

The unadjusted p-value is 0.008. In general, a p-value evaluates how compatible the observed data are with a specified null model, conditional on the assumptions of the test. A smaller p-value indicates that results like the observed comparison would be less common under that null model. It does not measure the probability that the null is true, nor does it quantify the likelihood that the intervention will benefit an individual. The registry does not report a full sponsor analysis or the planned testing procedure, so this value should be understood as an unadjusted recalculation rather than a documented adjusted trial analysis.

“Unadjusted” is important because the reported comparison does not account for testing multiple outcomes or other adjustments. The registry contains numerous outcome measures and follow-up times. If many comparisons are examined, some may appear more unusual by chance even when there are no underlying differences. Whether the trial had a prespecified strategy for handling this issue is not reported in the registry record.

Why can over-dispersion matter?

General statistical explanation: a model that assumes a particular level of variability can understate uncertainty if the observed data are more variable than that model allows. This is called over-dispersion in settings where the model’s variability is too small for the data. The primary endpoint is summarized as a continuous score with a standard deviation, and the registry comparison uses a pooled standard deviation. No over-dispersion analysis or diagnostic is reported, and the record does not indicate that over-dispersion is the principal issue for this endpoint. The general point is that uncertainty depends on how well the calculation represents the data’s variability.

For a continuous outcome, the arm standard deviations and sample sizes contribute to the uncertainty of a difference in means. The comparison record gives standard errors of 0.359 for Group II and 0.453 for Group I. A standard error describes the estimated variability of an estimator across repeated samples under a calculation’s assumptions; it is not the same as the spread of individual participant scores. The calculation method and any adjustment for other variables are not reported in the registry record.

What can randomization and masking tell us?

Random assignment is intended to make group membership independent of participants’ measured and unmeasured characteristics on average, subject to the way randomization was conducted and preserved. It does not guarantee that the outcome groups are identical, particularly with a limited number of observations. The registry identifies the study as double-masked, but does not say who was masked, how masking was maintained, or whether it could have been inferred from the intervention. These details limit assessment of possible bias in outcome collection or interpretation.

The registry supplies arm-level summaries and an unadjusted comparison; it does not report a detailed analysis protocol, covariate adjustment, missing-data method, or analysis population. A reader therefore cannot verify whether the calculation follows the trial’s intended analysis. The displayed recalculation is a simple comparison of posted summary statistics. Because the record does not identify a competing sponsor analysis, the numerical interpretation should remain tied to that unadjusted comparison and its stated limitations.

11. Confidence Intervals and Precision

The primary mean difference is 1.53 points, with an interval from 0.398 to 2.662. The interval lies above zero, but it spans values that differ in magnitude. This means the observed data support a positive difference under the calculation, while leaving uncertainty about the size of that difference. A point estimate is not an exact value for the underlying group difference.

The interval’s precision depends on the sample information and the variability of the endpoint. The primary arm summaries include 23 participants in Group I and 24 in Group II, with standard deviations of 2.17 and 1.76. The standard errors listed for the two group means are 0.453 and 0.359. These statistics characterize sampling uncertainty under the recalculation; they do not incorporate unknown effects of missing data, choices made in the original analysis, or departures from the calculation’s assumptions.

The registry does not state the confidence level associated with the reported interval. It is therefore best to refer to its endpoints without assigning a level. Nor does the record report a minimum important difference for the checklist. Statistical precision and practical importance are distinct: an interval can help describe uncertainty about the mean difference, but it cannot establish whether that difference is meaningful to patients without a relevant interpretive threshold.

The interval is also specific to the primary outcome, timepoint, and unadjusted comparison. It does not provide precision for distress, quality of life, or outcomes at other follow-up times. Those questions require their own estimates and uncertainty summaries, and the registry record does not report all such analyses.

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 events. They are illustrations calculated from the observed primary effect, rather than a record of the trial’s original design calculation. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to a stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

For planning at 100% of the observed effect, the figures are 27 participants per arm for 80% power and 35 participants per arm for 90% power. At 75% of the observed effect, they are 47 participants per arm for 80% power and 63 participants per arm for 90% power. At 50% of the observed effect, they are 105 participants per arm for 80% power and 140 participants per arm for 90% power.

In plain terms, the 80% power column describes the planning number per group that would give the stated chance of detecting the chosen effect under the listed assumptions if the assumed effect were real. The 90% power column uses a higher target chance of detection, which entails larger planned groups for each effect assumption. The figures are not observed power: they do not describe the probability that this completed trial detected an effect after its results were known.

Smaller effects are harder to distinguish from random variation, so planning to detect a smaller fraction of the observed effect requires more participants per arm. The observed effect is an estimate from this trial’s posted summaries and may not be the effect a future study would encounter. These calculations should therefore be read as conditional planning illustrations, not as a definitive sample-size recommendation for a new study.

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 = 1.530; pooled standard deviation σ = 1.971.
2. n = 2 × (1.96 + 0.842)² × 1.971² / 1.530² = 26.1, rounded up to 27 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 <- 1.53                      # observed difference in means
sigma <- 1.97112827250452                     # 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(5564468)
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 = 27 (80% power), 35 (90% power)
 75% of observed effect: n per arm = 47 (80% power), 63 (90% power)
 50% of observed effect: n per arm = 105 (80% power), 140 (90% power)
power.t.test: 27 
Simulated power at n = 27 per arm: 0.795 (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 registry describes a primary endpoint and a large group of secondary outcomes. Testing many outcomes, subscales, and follow-up times creates a multiplicity problem: the more comparisons made, the greater the opportunity for one or more results to appear unusual by chance. This is a general statistical concern, not evidence that any particular reported result is false. The record does not report a multiplicity-adjustment method, a hierarchy among secondary outcomes, or a plan distinguishing confirmatory from exploratory comparisons.

The posted comparisons are unadjusted. Without a reported testing strategy, their p-values should not be read as if each were the only hypothesis tested. The primary outcome has a clearer role in the registry description than the secondary measures, but the analysis plan that would establish the intended inferential status is not reported in the registry record.

Missing-data handling is also not described. The primary outcome summaries include 23 participants in Group I and 24 in Group II, whereas the enrollment listed is 100. These figures alone do not explain how many participants were randomized, how many provided data at each timepoint, or why the summary counts differ. They also do not establish whether missing outcome values were excluded, imputed, or handled by another method. The amount, timing, and reasons for missing data are not reported in the registry record.

The analysis populations are not reported either. The record does not specify whether comparisons used all randomized participants, only participants with observed outcome data, or another defined group. This matters because the interpretation of a randomized comparison depends partly on who is included and how participants are handled after randomization.

Although the registry identifies the study as double-masked, it does not provide details of the masking procedure or the analysis plan. Interim analyses, stopping rules, and whether any outcome analyses were adjusted for baseline values are not reported in the registry record. These missing details do not negate the posted summaries, but they constrain assessment of how the reported comparisons relate to the intended trial analysis.

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.

Most frequent non-serious adverse event terms

The registry’s safety counts list serious adverse events affecting 0 of 36 participants at risk in Group I and 0 of 35 at risk in Group II. It also lists other adverse events affecting 3 of 36 in Group I and 0 of 35 in Group II. Deaths are listed separately: 6 in Group I and 4 in Group II.

These counts should be read as descriptive registry entries, not as a full comparison of safety. The record does not provide the event terms for the other adverse events, their severity, timing, or whether they were considered related to the intervention. It also does not explain the relationship between deaths and adverse-event categories, so the death counts should not be assumed to be either included in or separate from particular event classifications beyond how they are listed.

The numbers at risk for these safety summaries differ from the primary outcome sample sizes. The registry does not explain those denominator differences. With no reported detail on event definitions, follow-up completeness, or attribution, these figures cannot establish comparative risk or explain why any event occurred.

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

The posted primary result describes a higher average change in the completed-task checklist in the web-tool group than in the standard-care group over the period from baseline to week 4. It is evidence about the measured outcome in the participants represented by the posted summaries. The interval and unadjusted p-value add information about uncertainty under the calculation’s assumptions, but they do not remove uncertainty about the analysis population, missing data, or the broader trial methods.

The score is a count of completed tasks. It does not establish that participants completed every task relevant to their circumstances, that tasks were completed outside the website, or that a completed task led to a particular decision or outcome. The result also does not directly measure distress, emotional support, quality of life, or satisfaction with planning. While the program’s stated aims include areas beyond the checklist, the primary result should not be extended to those outcomes.

The findings do not establish that the tool works or does not work in a general clinical population. The registry describes participants with advanced cancers and a specific web-based program, but does not report enough detail about participant characteristics or analysis procedures to assess how broadly the numerical estimate applies. The four-week endpoint also does not show whether any observed difference persisted to later follow-up.

A registry result is not the same as a complete account of a trial’s methods and findings. The original statistical plan, analysis populations, missing-data approach, and adjusted sponsor analysis are not reported in the registry record. Those omissions limit the conclusions that can be drawn from the posted summaries. The responsible interpretation is narrow: the group mean changes differed on the specified checklist measure at the specified timepoint, with uncertainty described by the unadjusted comparison.

Nothing in these statistics determines what planning is appropriate for an individual, and the result is not a recommendation about care. It is a quantitative description of a trial outcome and its uncertainty. Decisions about the meaning of the score difference would require an interpretive threshold and contextual evidence that the registry does not report.

17. Why This Trial Matters Statistically

This trial is statistically interesting because its primary endpoint turns a broad concept—end-of-life planning—into a count of completed tasks. Such an operational definition makes the target measurable, but it also sets boundaries on what the result means. A difference in task counts is not interchangeable with a difference in distress, preparedness, communication quality, or patient-centeredness. The endpoint definition therefore shapes both the analysis and its interpretation.

The comparison also illustrates why effect estimates, uncertainty intervals, and p-values should be read together. The estimated mean difference gives the direction and scale of the observed contrast; the interval describes uncertainty about its magnitude; and the p-value assesses compatibility with a null model under specified assumptions. None of these summaries alone answers whether the difference is important in practice. The registry does not give a meaningful-difference threshold for this score.

Another important issue is the distinction between an observed effect and a planning assumption. Sample-size illustrations based on the observed difference can help show how planning requirements change when a smaller effect is targeted. They are not the original justification for this trial, and they should not be confused with an after-the-fact probability that the trial succeeded in detecting an effect.

Finally, the record highlights how reporting completeness affects statistical interpretation. Outcome counts differ from the enrollment listed, and analysis populations, missing-data methods, and multiplicity procedures are not reported. These details are essential for understanding how robust a randomized comparison is and how much weight to give secondary findings. A careful reading keeps the conclusion tied to the outcome and participants summarized, while treating unreported methods as unresolved rather than filling them in by assumption.

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.

The primary outcome counts include 23 participants in Group I and 24 in Group II, while the registry lists an enrollment of 100. The record does not explain the difference or report the number randomized and followed at each timepoint. As a result, the scope of the analyzed population and the possible effect of missing data cannot be assessed from the registry summaries.

The statistical analysis is incompletely described. A planned analysis, analysis population, adjustment for baseline values, missing-data strategy, and multiplicity approach are not reported in the registry record. The posted primary comparison is an unadjusted recalculation from the arm summaries, rather than a reported sponsor analysis. This limits the ability to determine whether it reflects the trial’s intended inferential analysis.

The primary outcome is measured at week 4, while the registry also lists later follow-up measures. The available numerical comparison records do not provide a complete account of all listed outcomes and times. Consequently, persistence of the primary difference and the full pattern of later outcomes cannot be assessed from these summaries.

The intervention is a web-based tool with several intended planning domains, but the primary score counts completed checklist tasks. The record does not report a threshold for a meaningful score difference or establish how the task count relates to participants’ broader planning needs. The registry also gives limited detail on standard care, masking procedures, participant characteristics, and intervention use. Those omissions restrict assessment of implementation and generalizability without changing what the posted checklist comparison itself describes.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer — NCT05564468.
• Registry record last updated 2026-10-02; status last verified 2026-09.
• Results first posted 2026-10-02.
• 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, double-masked, parallel-group study of Peacefully’s web-based end-of-life planning tool versus standard care in patients with advanced cancer. The listed enrollment is 100. The primary endpoint is change in a 14-item completed-task checklist from baseline to week 4.

The primary arm means are 1.57 for Group I and 0.04 for Group II, with an unadjusted mean difference of 1.53 and an interval from 0.398 to 2.662. The unadjusted p-value is 0.008. The comparison is based on posted summary statistics; the registry record does not report the sponsor’s analysis plan, analysis population, or missing-data methods.

Secondary outcomes cover advance-care-planning engagement and conversations, with a mixed pattern across the available week-4 comparisons. Serious adverse events are listed for neither group, while other adverse events and deaths are reported as descriptive counts. The record does not provide enough detail to interpret event attribution or fully assess the secondary analyses.