POEM (Practice Of Embracing Each Moment) STUDY: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for POEM (Practice Of Embracing Each Moment) STUDY (NCT03078608), a randomized na study. The primary outcome is Change in Anxiety--patients.

2. Clinical Question

3. Trial Design

POEM (Practice Of Embracing Each Moment) was a randomized, single-masked, parallel-group pilot study of a mobile or online mindfulness intervention for cancer patients and caregivers. The registry lists the study phase as NA and the status as completed. Its stated context is that cancer and chemotherapy can be emotionally challenging, while extended in-person programs may be difficult for patients to attend. The app-based format was intended to be accessible at home or at infusion clinics.

The registry describes three groups: an intervention arm receiving app-based mindfulness meditation, an active control arm receiving app-based progressive muscle relaxation, and a wait-list control arm that would receive the meditation program after the intervention group completed its program. Participants in the active intervention and active control arms were asked to practice their assigned program daily for 8 weeks. The primary reported comparison is narrower: patients in the intervention arm versus patients in the wait-list control arm. The active control is not included in that primary comparison.

The study planned to evaluate acceptance and usefulness of the mobile program and the feasibility of randomizing participants among the three groups, as a basis for a possible future study. The registry lists total enrollment as 128. The primary outcome is change in patient anxiety from baseline to 8 weeks. The posted primary group summaries contain 39 intervention-arm patients and 30 wait-list patients, so the outcome summary does not include everyone counted in total enrollment.

The identity of the masked party, eligibility details beyond the described population, allocation procedures beyond randomization, and the original sample-size justification are not reported in the registry record. Nor is a detailed protocol for how the pilot feasibility aims were assessed 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Comparison of outcome in patients assigned to the intervention arm vs. patients assigned to the wait list control arm

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 Anxiety--patients, measured over Baseline to 8 weeks.

The primary endpoint is mean change in anxiety among patient-participants from baseline to 8 weeks. Anxiety was measured with the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS), a self-report measure described in the registry as frequently used for psychosocial outcomes in cancer patients and designed for medical outpatient settings. The HADS contains separate depression and anxiety subscales; each is scored from 0 to 21. Higher scores indicate greater distress. The registry describes score ranges as generally normal, mild, moderate, or severe, but those categories do not replace the trial’s comparison of change in the continuous score.

A change score expresses how a participant’s score differs between the stated measurement times. The posted results summarize the average change in each group and compare those averages. Negative group means indicate that the average score was lower at follow-up than at baseline, given the stated direction of the measure. The intervention-arm mean change was -1.4 and the wait-list mean change was -1.5.

An anxiety measure is relevant to the study’s stated concern about emotional distress in patients affected by cancer. Using a continuous score preserves differences across the scale rather than reducing each person’s result to a symptom category. However, the registry record does not report a threshold for a clinically important change, nor does it establish that a particular difference in this score would be meaningful to participants. The endpoint therefore describes reported anxiety-score change, not a direct measure of the program’s acceptability or the feasibility of conducting a larger trial.

7. Results Posted in the Registry

• Intervention Arm--PATIENTS: mean -1.40 versus -1.50 on control; difference 0.10 (95% CI -1.36 to 1.56), standardized effect d = 0.03; z-test p = 0.893.

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 Distress--patients

• 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:
  • Intervention Arm--PATIENTS: mean -0.80 versus -0.50 on control; difference -0.30 (95% CI -1.48 to 0.88), standardized effect d = -0.11; z-test p = 0.617.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention Arm--PATIENTS and the control. The interval gives the range of effects that remain compatible with the data.

Change in Fatigue--patients

• 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:
  • Intervention Arm--PATIENTS: mean -0.80 versus 0.00 on control; difference -0.80 (95% CI -1.61 to 0.01), standardized effect d = -0.45; z-test p = 0.053.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention Arm--PATIENTS and the control. The interval gives the range of effects that remain compatible with the data.

Change in Pain Interference--patients

• 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:
  • Intervention Arm--PATIENTS: mean -2.20 versus 0.80 on control; difference -3.00 (95% CI -7.76 to 1.76), standardized effect d = -0.36; z-test p = 0.217.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention Arm--PATIENTS and the control. The interval gives the range of effects that remain compatible with the data.

The registry names secondary outcomes for distress, fatigue, and pain interference among patients and caregivers. The posted numerical comparisons available for interpretation concern patient distress, fatigue, and pain interference. Numerical caregiver comparisons are not reported in the registry record. Across the posted patient outcomes, the estimates do not all point in the same direction or have the same degree of uncertainty. The sponsor-reported ANOVA p-values for these outcomes are 0.67, 0.24, and 0.25.

These secondary outcomes add context to the primary anxiety result, but they do not replace it. They address different reported measures, and the listed outcomes include both patient and caregiver experience. The secondary pattern does not provide a single consistent account of changes across all measures. The registry does not report a prespecified hierarchy that would establish one secondary result as confirmatory or more important than another.

Unadjusted secondary results carry less weight because multiple outcomes create multiple opportunities for apparently notable findings, even when there is no underlying effect. General statistical principle: when many comparisons are examined, chance findings become more likely unless the analysis accounts for multiplicity or the results are treated as exploratory. The registry lists 10 outcome measures and 10 analyses, but a multiplicity adjustment is not reported in the registry record. The secondary results should therefore be interpreted as descriptive and hypothesis-generating, not as independent confirmation of the primary outcome.

The posted patient summaries are based on differing group sizes across outcomes. The registry record does not report how those differences arose or how missing outcome measurements were handled. The secondary results also do not report caregiver estimates in the numerical data available for interpretation, so conclusions about caregiver outcomes cannot be drawn from the listed patient comparisons.

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

• Change in Distress--patients
• Change in Fatigue--patients
• Change in Pain Interference--patients
• Change in Distress--caregivers
• Change in Fatigue--caregivers
• Change in Pain Interference--caregivers

9. Statistical Interpretation

10. Statistical Methods Explained

What is being compared?

The primary outcome is a continuous score, so the posted group summaries use a mean and standard deviation. The mean describes the average change in each group, while the standard deviation describes how dispersed individual changes are around that group average. The intervention group’s mean change was -1.4, with a standard deviation of 3.5; the wait-list group’s mean was -1.5, with a standard deviation of 2.7. The group sizes were 39 and 30, respectively.

The recalculated mean difference is expressed as the intervention-group mean minus the wait-list mean. Its posted estimate is 0.1. A positive estimate means the intervention group’s change score was higher on average than the wait-list group’s change score; because both group means are negative, this describes a slightly smaller average decline in the intervention group. This wording concerns the score arithmetic only and does not establish a meaningful difference in anxiety.

What does an interval estimate convey?

A confidence interval describes uncertainty around an estimated contrast under the assumptions of the method used. It gives a range of values compatible with the observed summary data and the method’s uncertainty calculation. The recalculated interval for the primary mean difference runs from -1.363 to 1.563. Because it crosses zero, it includes no difference as well as values in either direction. The confidence level associated with the displayed interval is not reported in the registry record, so it should not be inferred from the interval endpoints alone.

An interval is not a list of all possible true values, nor does it assign an individual probability to each value. Its width reflects how precisely the difference is estimated under the calculation. Here, the interval is broad relative to the point estimate, so the small estimated difference should not be mistaken for a precise estimate of the contrast.

How should the p-values be read?

The recalculated primary p-value is 0.893 and is labeled unadjusted. In general, a p-value measures how unusual the observed data, or data more extreme, would be under a specified null model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The registry also reports a sponsor ANOVA result with F statistic 0 and p = 1.00. These are results from different reported presentations; the registry does not provide enough analysis detail to explain fully why their numerical summaries differ.

The sponsor’s ANOVA is the reported analysis, while the recalculated contrast is a simple unadjusted comparison from the posted summary statistics. The recalculation does not account for covariates, repeated measurements, or other participant-level features unless those are encoded in the posted summaries, and the registry does not report whether such features were included in the sponsor’s model. It should therefore be read as a transparent summary-statistic comparison, not as a reconstruction of the full analysis plan.

Why can variability matter?

When individual changes vary considerably, the group average may be estimated less precisely, especially when the outcome summaries include relatively few participants. The primary group standard deviations, 3.5 and 2.7, describe variation in observed change. A mean difference alone hides that variation; the interval and standard errors help communicate how uncertain the comparison is. General statistical principle: more variability makes it harder to distinguish a group contrast from random variation, all else being equal.

The recalculation uses the posted standard deviations directly; the record indicates that they were not approximated. The planning illustrations use a normal approximation and equal allocation assumptions, but those are planning assumptions for the illustrations, not documented assumptions of the original pilot’s design.

What is the role of randomization and the pilot design?

Random assignment is intended to create groups that can be compared without choosing treatment based on participants’ characteristics. In practice, chance differences can remain, particularly in a pilot. The registry identifies the study as randomized and parallel-group, but details of sequence generation, concealment, and the identity of the masked party are not reported in the registry record. The record also does not describe the analysis population or how participants with missing outcome measurements were handled.

The study was designed as a pilot with aims that included acceptance and feasibility. A pilot can provide information about implementation and outcome variability, but the registry’s posted anxiety comparison does not itself establish how acceptable the program was or whether randomization was feasible. Those specific findings are not reported in the registry record. No interim-analysis plan or original statistical analysis plan is reported in the registry record.

11. Confidence Intervals and Precision

The primary recalculated mean difference is 0.1, with interval limits of -1.363 and 1.563. The interval includes zero, so the posted summary is compatible with no difference in average change as well as with differences favoring either group. It is also wide enough that the point estimate alone gives an incomplete impression of what the data allow. The registry record does not report the confidence level for this interval, so no confidence percentage should be attached to it based on the record alone.

Precision depends on the amount of observed variability and the number of outcome observations. The primary summaries report standard deviations of 3.5 and 2.7, with 39 and 30 patients in the respective groups. Those sample sizes are smaller than total enrollment of 128. The registry record does not explain why the primary outcome summaries contain fewer participants than total enrollment, or how missing endpoint observations were handled.

The interval is a measure of statistical uncertainty for the recalculated mean difference; it is not a measure of the range of individual patient changes. Nor does it tell whether a value inside the interval is clinically important. A clinically meaningful difference threshold is not reported in the registry record. The interval should therefore be read as showing uncertainty around the group contrast, without assigning clinical meaning to its endpoints.

The sponsor’s ANOVA result reports p = 1.00 but does not include a confidence interval. The recalculated interval helps describe uncertainty for the unadjusted contrast based on posted summary statistics, but it does not supply the missing details of the sponsor’s model. The registry record does not report whether the sponsor calculated an interval by another method.

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 illustrations give participants per arm for the continuous-outcome comparisons, not total events. They are based on the observed effect and show planning for 100%, 75%, and 50% of that observed effect. The stated planning 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 the stated percentage of the observed effect. The trial’s original design assumptions and its own sample-size justification are not reported in the registry record.

The 80% power column gives the illustrated number of participants per arm for a study designed, under those assumptions, to have an 80% chance of detecting the selected effect if that effect is present. The 90% power column gives the corresponding number for a 90% chance. These are prospective planning quantities, not a measure of what the completed pilot achieved. The figures are not observed power.

Each row changes the effect size used for planning. Smaller effects are harder to distinguish from random variation, so the illustrations require more participants per arm when planning for a smaller portion of the observed effect. For example, the primary-outcome row for 100% of the observed effect lists 15,860 participants per arm for 80% power and 21,232 for 90% power; the row for 50% lists 63,439 and 84,927, respectively. These figures are not proposed trial targets and do not establish what sample size would be appropriate for a future study. The planning calculation is based on the observed effect, which itself is uncertain in a pilot.

A sample-size curve, if read alongside these rows, represents the same general relationship between effect size and required sample size under the stated assumptions. It is a planning aid rather than a description of the participants actually enrolled. No time-to-event outcome is being summarized in these illustrations.

13. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = 0.100; pooled standard deviation σ = 3.179.
2. n = 2 × (1.96 + 0.842)² × 3.179² / 0.100² = 15,859.7, rounded up to 15,860 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.1                      # observed difference in means
sigma <- 3.1785427995165                     # 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(3078608)
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 = 15,860 (80% power), 21,232 (90% power)
 75% of observed effect: n per arm = 28,195 (80% power), 37,746 (90% power)
 50% of observed effect: n per arm = 63,439 (80% power), 84,927 (90% power)
power.t.test: 15860.6 
Simulated power at n = 15,860 per arm: 0.798 (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. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary analysis as an ANOVA with F statistic 0 and p = 1.00. The posted arm summaries give mean changes of -1.4 for the intervention group and -1.5 for the wait-list group. A simple unadjusted recalculation from those means, standard deviations, and group sizes estimates a mean difference of 0.1, with an interval from -1.363 to 1.563 and p = 0.893.

These are not identical numerical summaries. The recalculation is a transparent comparison of the posted summary statistics; it does not recreate a participant-level model. The registry does not report sufficient details about the sponsor’s ANOVA specification, analysis population, handling of missing outcomes, or any other model features to determine the source of the numerical difference. The registry record does not flag a discrepancy between analyses, but that does not make the two approaches interchangeable.

The sponsor’s ANOVA is the registry’s reported analysis. The recalculated interval and p-value add a simple unadjusted perspective on the posted means, rather than replacing the sponsor’s analysis or establishing a different primary conclusion. Neither result alone resolves the uncertainty about the size or practical importance of any group difference.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and 10 analyses, including a primary anxiety outcome and named secondary outcomes for distress, fatigue, and pain interference in patients and caregivers. Multiple outcomes can increase the chance that at least one result appears noteworthy by chance. General statistical principle: multiplicity procedures can control or describe that issue, but they can also affect how results are interpreted. Whether an adjustment was planned or applied is not reported in the registry record. Accordingly, the secondary p-values should not be treated as if each were the only test conducted.

The record identifies the primary comparison and reports the sponsor’s ANOVA result, but a full statistical analysis plan is not reported in the registry record. It is not reported whether the outcome hierarchy, covariate adjustment, handling of repeated measurements, or analysis populations were specified before the results were examined. Interim analyses are also not reported in the registry record. These omissions limit the ability to assess how the reported analyses relate to a prespecified plan.

Missing outcome data are a particular interpretive issue because the posted primary summaries include 39 intervention patients and 30 wait-list patients, while total enrollment is 128. Other patient outcomes have different numbers of observations. The registry record does not report why those numbers differ, how much outcome data were missing, whether missingness differed by group, or what methods were used to address missing data. No assumptions about the unobserved outcomes can therefore be evaluated from the record.

The record also does not report a defined analysis population, such as whether all randomized participants were included regardless of program use, or how participants were handled if they did not follow the assigned practice schedule. The app programs asked participants to practice daily for 8 weeks, but adherence results are not reported in the registry record. Without these details, the posted summaries describe the available outcome data but do not establish the effect of assignment under a fully specified analysis strategy.

16. 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’s safety summaries list serious adverse events and other adverse events separately from deaths. For patient participants, the intervention group lists 54 at risk, with zero serious adverse events and zero other adverse events; the wait-list group lists 43 at risk, also with zero serious and zero other adverse events. The safety groups and their at-risk counts are not the same as the primary endpoint analysis groups.

For caregivers, the intervention group lists 17 at risk and the wait-list group lists 14 at risk. Both groups report zero serious adverse events and zero other adverse events. The registry lists 1 death in the patient intervention group and 2 in the patient wait-list group, and zero deaths in each caregiver group.

Deaths are listed as a separate count; the registry record does not report whether they were related to study participation or treatment, or provide circumstances or timing. Zero reported serious or other adverse events means none were recorded in these registry categories for the listed groups; it does not establish that no health events occurred or that an intervention caused or prevented an event. The record does not provide further safety detail or a causal assessment.

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

The primary result describes average change in patient anxiety scores between baseline and 8 weeks in the intervention and wait-list groups. The group means were -1.4 and -1.5, and the recalculated mean difference was 0.1. Its interval includes zero and values on both sides, so the posted summary does not give a precise estimate of the direction or size of a group difference.

This result does not show that the two groups are identical. It also does not establish that mindfulness meditation is effective or ineffective. The estimate is uncertain, the sample contributing to the primary outcome is smaller than total enrollment, and a clinically meaningful difference threshold is not reported in the registry record. The sponsor’s reported ANOVA result is also a statistical comparison, not a direct measure of whether participants found the app acceptable or useful.

The trial was described as a pilot and included aims about acceptance, usefulness, and the feasibility of randomizing participants among intervention, active control, and wait-list groups. The posted anxiety comparison does not answer all of those aims. The registry record does not report specific feasibility findings, adherence information, or numerical caregiver secondary results. It therefore does not support conclusions about how consistently participants used the program or how caregivers’ outcomes changed.

The safety counts are also limited to the registry’s reported categories and groups. The zero serious and other adverse-event counts do not prove the absence of all health events, and the separate death counts do not establish a relationship to study participation. Overall, the posted data describe selected outcomes in this pilot; they do not settle the broader questions that the study was intended to inform.

18. Why This Trial Matters Statistically

This trial raises several statistical questions that are especially important in pilot studies. The registry describes a randomized comparison, multiple study arms, patient and caregiver populations, and a continuous primary outcome. Yet the posted primary estimate is based on fewer participants than total enrollment, and the interval around the mean difference is broad. Those features make it important to distinguish the point estimate from the uncertainty around it.

The study also illustrates the difference between a pilot’s feasibility aims and a confirmatory test of an outcome. The stated intention was to assess whether a mobile mindfulness program was accepted and useful and whether randomization among three groups was feasible, in preparation for a possible future study. The primary anxiety score is relevant to the intervention’s rationale, but it does not by itself answer whether the app was acceptable, whether participants practiced as requested, or whether the three-group design was workable. Those specific results are not reported in the registry record.

Another statistical issue is the relationship between sponsor-reported analyses and simple recalculations from arm summaries. The sponsor’s ANOVA and the recalculated unadjusted comparison are distinct presentations. A clear distinction helps readers avoid treating a calculation from summary statistics as if it were a full reconstruction of the analysis plan. The record lacks several details needed to evaluate that relationship fully.

Finally, the listed outcomes raise questions about multiplicity and missing data. Several outcomes and populations are named, but adjustment for multiple comparisons and the handling of missing measurements are not reported in the registry record. These are not technical footnotes: they affect how confidently secondary patterns can be interpreted and how well the posted summaries represent the randomized groups. Recognizing these limits helps keep conclusions proportional to the information available.

19. 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 leaves important details of the trial’s conduct and analysis unspecified. It identifies the study as randomized, single-masked, and parallel-group, but does not say who was masked or describe sequence generation or allocation concealment. Eligibility criteria beyond the described cancer-patient and caregiver population are not reported in the registry record. These omissions make it difficult to assess recruitment and risk of bias from the record alone.

Total enrollment is 128, while the primary outcome summaries include 39 intervention patients and 30 wait-list patients. The record does not explain the difference, report the amount or pattern of missing outcome data, or describe any method used to address missingness. Outcome group sizes also vary across the posted patient secondary summaries. Caregiver outcome estimates are not reported in the numerical results, despite caregiver outcomes being listed.

The intervention and wait-list comparison does not include the active progressive muscle relaxation arm in the posted primary result. The registry does not report a numerical comparison against that active control, so the primary contrast cannot distinguish mindfulness-specific effects from effects associated with app access, daily practice, or other features common to an active program. This is a limitation of the reported comparison, not a claim about the design’s full aims.

The record does not report the original sample-size justification, an analysis plan, multiplicity handling, interim analyses, adherence results, a clinically meaningful change threshold, or detailed feasibility findings. The pilot’s planning illustrations are based on the observed effect and should not be mistaken for the original design rationale. These reporting gaps constrain interpretation of both the primary outcome and the secondary results.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: POEM (Practice Of Embracing Each Moment) STUDY — NCT03078608.
• Registry record last updated 2025-04-16; status last verified 2025-03.
• Results first posted 2025-04-16.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

POEM was a completed randomized, single-masked, parallel-group pilot study sponsored by Kaiser Permanente. It evaluated an app-based mindfulness meditation program for cancer patients and caregivers, with progressive muscle relaxation as an active control and a wait-list control. Total enrollment was 128.

The primary posted patient outcome was mean change in HADS anxiety score from baseline to 8 weeks, comparing the intervention with the wait-list group. The means were -1.4 and -1.5, respectively; the recalculated mean difference was 0.1, with an interval from -1.363 to 1.563. The sponsor reported an ANOVA with F statistic 0 and p = 1.00.

Secondary outcomes include distress, fatigue, and pain interference for patients and caregivers. Numerical patient results are posted for selected outcomes, while caregiver numerical results are not reported in the registry record. The record does not report the original sample-size justification, missing-data methods, multiplicity adjustment, or specific feasibility findings.