Individualized Music Listening in Acute Leukemia Patients With Fatigue: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Individualized Music Listening in Acute Leukemia Patients With Fatigue (NCT06286332), a randomized na study. The primary outcome is Change in Fatigue Score on the Tang Fatigue Rating Scale (TFRS).

2. Clinical Question

3. Trial Design

The study is registered as a randomized, double-masked, parallel-group trial and is marked completed. Chang Gung University is listed as the sponsor. The registry gives an enrollment of 60. The primary outcome summaries include 27 participants in the individualized music-listening group and 28 in the standard care group. These counts describe the outcome summaries; participant flow from enrollment to the primary analysis is not reported in the registry record.

Participants assigned to individualized music listening received self-selected music through an app for 30 minutes every day, in addition to standard therapy. Participants assigned to standard care received standard care alone. Both groups were followed over a study duration of 21 days. The registry lists the study start as 2024-04-01 and the primary completion as 2024-11-30.

The primary outcome was the change in the Tang Fatigue Rating Scale total score from baseline to Day 21. Secondary outcomes listed in the record were albumin, hemoglobin, and absolute neutrophil count, measured at Day 21. The registry record does not explain how masking was implemented for participants, care providers, or outcome assessors. It also does not describe the allocation procedure beyond identifying the study as randomized.

The record does not report the original sample-size justification, the planned statistical analysis, analysis populations, or methods for handling incomplete measurements. It lists no reported analyses. The comparisons discussed in the statistical interpretation are unadjusted recalculations from the posted summary statistics, rather than a registry-reported adjusted analysis.

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:

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.

Population: Baseline characteristics are reported for participants who completed the study and were included in the final analysis.

6. Primary Endpoint

The registry lists the primary outcome as Change in Fatigue Score on the Tang Fatigue Rating Scale (TFRS), measured over Baseline (T0) to Day 21 (T21).

The primary endpoint was change in the total score on the Tang Fatigue Rating Scale from baseline (T0) to Day 21 (T21). The TFRS is a validated, self-reported measure of average fatigue intensity. It contains 37 items, each scored on a scale from 1 to 10, and its total score ranges from 37 to 370. Higher totals indicate greater fatigue.

A change score is intended to describe how a participant’s measured fatigue differs between the start and end of the specified period. Comparing average change between randomized groups can summarize how their recorded trajectories differed during the study. However, the registry record does not state whether change was calculated as the Day 21 score minus baseline or baseline minus the Day 21 score. That convention matters when assigning a direction to a positive or negative change.

The posted arm summaries report mean change scores of 14.7 for individualized music listening and 54.78 for standard care. Their reported standard errors are 10.64 and 8.32, respectively. The primary comparison is the difference between those mean change scores. The scale’s validation and direct focus on fatigue make it relevant to the study question, but the score alone does not establish the clinical importance of a group difference. A threshold for clinically meaningful change is not reported in the registry record.

7. Results Posted in the Registry

• Individualized Music-Listening Group: mean 14.70 versus 54.78 on control; difference -40.08 (95% CI -66.55 to -13.61), standardized effect d = -0.80; z-test p = 0.003.

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.

Albumin

• 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:
  • Individualized Music-Listening Group: mean 3.87 versus 3.49 on control; difference 0.38 (95% CI 0.31 to 0.45), standardized effect d = 2.81; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Individualized Music-Listening Group than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Hemoglobin

• 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:
  • Individualized Music-Listening Group: mean 9.30 versus 8.19 on control; difference 1.11 (95% CI 0.98 to 1.24), standardized effect d = 4.52; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Individualized Music-Listening Group than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Absolute Neutrophil Count（ANC)

• 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:
  • Individualized Music-Listening Group: mean 2,456 versus 1,374 on control; difference 1,083 (95% CI 737.55 to 1,428), standardized effect d = 1.66; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Individualized Music-Listening Group than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted Day 21 summaries show higher group means for each of the three listed laboratory outcomes in the individualized music-listening group than in standard care. Each unadjusted recalculated comparison has a p-value of <0.001. These outcomes cover albumin, hemoglobin, and absolute neutrophil count, rather than fatigue itself.

As a group, the secondary results add descriptive information about laboratory measurements at the end of the 21-day study period. They do not provide a second measurement of the primary patient-reported fatigue outcome, and their direction cannot resolve the TFRS change-score convention. A difference in a laboratory measure should not be treated as evidence of a corresponding difference in fatigue, or as proof of a clinically important change, without appropriate clinical context and analysis.

The registry record lists no reported analyses for the secondary outcomes. The reported p-values and mean differences are unadjusted recalculations from summary statistics. Because several outcomes are considered, the chance of observing apparently notable results across the set can be greater than for a single prespecified test. No multiplicity procedure or hierarchy among outcomes is reported in the registry record.

For that reason, the secondary results carry less confirmatory weight than a clearly prespecified primary analysis with a documented statistical plan. They are useful as a pattern of posted group summaries, but they should be viewed as exploratory evidence unless the analysis plan and multiplicity approach can be established. The record does not identify which secondary outcome, if any, was intended to support a particular claim, nor does it report whether all planned secondary analyses were completed.

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

• Albumin
• Hemoglobin
• Absolute Neutrophil Count（ANC)

9. Statistical Interpretation

10. Statistical Methods Explained

The numerical comparisons discussed in this interpretation are simple, unadjusted recalculations from the posted group summaries. They are useful for describing the size and uncertainty of mean differences, but they are not a substitute for a complete statistical analysis plan or an analysis based on participant-level records. The registry record lists zero reported analyses, so it does not document a sponsor-reported model, adjustment strategy, or analysis population.

What does a mean difference describe?

For a continuous outcome, a group mean is the arithmetic average of the recorded values in that group. The mean difference compares the averages, with the comparison expressed as individualized music listening minus standard care. A negative primary estimate means that the first group’s reported mean change score was lower than the second group’s. This arithmetic direction is separate from the clinical interpretation of change, which depends on the score’s subtraction convention.

The primary arm summaries give means and standard errors. A standard error describes the estimated uncertainty in a sample mean, rather than the spread of individual participant scores. A standard deviation, by contrast, describes the variability of participant measurements around a group mean. The secondary outcome summaries report standard deviations. These two measures of dispersion serve different purposes and should not be treated as interchangeable.

What does the interval add?

A confidence interval expresses uncertainty around an estimated difference. A narrower interval indicates greater precision under the analysis assumptions; a wider interval indicates that a broader range of differences remains compatible with the data. The interval for the primary mean difference is -66.55 to -13.61. The confidence level and the sponsor’s method for calculating an interval are not reported in the registry record. The intervals discussed for the comparisons are therefore best understood as part of the unadjusted recalculation, not as a documented result from an identified registry analysis.

General explanation: intervals are affected by both the variability of measurements and the amount of information available. They do not account automatically for design features, missing outcomes, or multiple testing. Those require explicit methods and decisions, none of which are described for the trial’s analyses in the registry record.

How should a p-value be read?

A p-value measures how surprising data at least as incompatible with a specified null model would be if that model and its assumptions were correct. It is not the probability that the null hypothesis is true, nor a measure of clinical importance. The primary recalculated p-value is 0.003. The secondary recalculated p-values are each <0.001. They are unadjusted, so they do not account for the fact that several outcomes are being examined.

General explanation: a smaller p-value can be evidence against a null model, but it does not reveal whether an estimate is large enough to matter in practice. It also does not address whether the analysis was planned, whether the data were complete, or whether the statistical model matches the study design. Those considerations are particularly relevant when no analysis plan or reported analysis is available in the record.

Why does over-dispersion matter?

General explanation: for continuous outcomes, larger variation among participants relative to the difference between group means makes a group contrast less precise. A model that assumes less variation than the data contain can produce uncertainty estimates that are too small. Conversely, extra variation may call for methods that represent it more adequately. The posted summaries do not report an over-dispersion assessment or a model-based variance adjustment, and the record does not describe a model that could be evaluated for this issue.

What can be inferred from the recalculation?

The recalculated comparisons use posted means and measures of dispersion to describe unadjusted group differences. They do not adjust for baseline characteristics, account for repeated measurements beyond the posted change score, or incorporate participant-level information that is absent from the summaries. Whether such adjustments were planned or performed is not reported in the registry record. Because the discrepancy indicator is false, no discrepancy between a recalculation and a sponsor result is flagged; nevertheless, the registry lists no sponsor analysis for comparison.

General explanation: randomized assignment can make group comparisons informative about intervention effects, but a transparent analysis also needs to specify which participants and outcomes are included, how missing observations are treated, and how uncertainty is calculated. These details are not documented in the registry record. The recalculated statistics should therefore be read as descriptive statistical comparisons of the posted summaries, not as a complete account of the trial’s statistical methods.

11. Confidence Intervals and Precision

The primary mean difference is -40.08 TFRS change-score points, with an interval from -66.55 to -13.61. The interval remains on the negative side of zero, while still spanning a substantial range of possible mean differences. This indicates that the estimate has uncertainty; it should not be reduced to a single exact value. The registry record does not report the confidence level or describe the method used for an official interval.

The separate group intervals are -66.59 to -13.56 for individualized music listening and 38.47 to 71.09 for standard care. These intervals describe uncertainty around the group summaries and are not interchangeable with the interval for the between-group difference. For a comparison, uncertainty in the difference is directly represented by the interval for that difference.

The primary arm standard errors are 10.64 and 8.32. They represent uncertainty in the estimated group means, not the range of fatigue changes among individual participants. The comparison is based on outcome summaries for 27 and 28 participants, respectively. The record does not explain why the outcome-summary counts differ from one another or from the enrollment figure.

General explanation: precision depends on the amount and variability of the information analyzed, as well as the method used to calculate uncertainty. Even an interval that excludes zero does not establish that an effect is clinically important or free of bias. Here, the interval quantifies the recalculated contrast under its assumptions; the undocumented analysis plan, change-score convention, and missing-data handling limit how fully its precision can be assessed.

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 sample-size figures are planning illustrations for the primary comparison, expressed as participants per arm. They are not total event counts. The calculation uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It considers effects equal to 100%, 75%, and 50% of the observed effect. The trial’s original design assumptions and sample-size justification are not reported in the registry record.

For planning around 100% of the observed effect, the illustration gives 25 participants per arm for 80% power and 33 participants per arm for 90% power. For planning around 75% of the observed effect, it gives 44 participants per arm for 80% power and 58 participants per arm for 90% power. For planning around 50% of the observed effect, it gives 98 participants per arm for 80% power and 131 participants per arm for 90% power.

In plain terms, the 80% column describes the number per group estimated to give an 80% chance of detecting the specified effect under the calculation assumptions, if that effect were the true one. The 90% column describes the corresponding planning target for a greater chance of detection. Smaller effects require more participants to distinguish them from random variation with the same planned power. These are illustrations based on the observed effect, not observed power for the completed trial.

Because the observed effect is used as the reference for these illustrations, the planning results are not independent evidence that the effect will recur. The figures also do not demonstrate that the completed study was designed according to these assumptions. The registry record does not report the original rationale, target power, or sample-size method used when the trial was planned.

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 = -40.080; pooled standard deviation σ = 49.869.
2. n = 2 × (1.96 + 0.842)² × 49.869² / -40.080² = 24.3, rounded up to 25 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 <- -40.08                      # observed difference in means
sigma <- 49.86874727439                     # 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(6286332)
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 = 25 (80% power), 33 (90% power)
 75% of observed effect: n per arm = 44 (80% power), 58 (90% power)
 50% of observed effect: n per arm = 98 (80% power), 131 (90% power)
power.t.test: 25.3 
Simulated power at n = 25 per arm: 0.800 (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 record identifies a primary fatigue endpoint and lists three secondary laboratory outcomes. Considering more than one outcome creates a multiplicity issue: when several statistical tests are performed, the chance of at least one apparently unusual result can increase, even when the tests do not represent separate confirmatory findings. General statistical practice addresses this through prespecified outcome hierarchies, adjustment procedures, or clear labeling of secondary analyses as exploratory. The registry record does not report a multiplicity plan or adjustment.

The primary p-value of 0.003 and secondary p-values of <0.001 are unadjusted recalculations. They should not be interpreted as though a family-wise or other multiplicity correction had been applied. Whether the study protocol specified such a correction is not reported in the registry record. No hierarchy for interpreting the outcomes is reported either.

Missing-data methods are also not reported in the registry record. The record does not state how missing baseline or Day 21 measurements were handled, whether participants with incomplete measurements were included in the primary comparison, or whether any imputation was used. The outcome summaries list 27 participants in one primary group and 28 in the other, while enrollment is recorded as 60; the record does not explain participant flow or those counts.

Analysis populations are not described. The registry record does not say whether the reported summaries use all randomized participants, participants who completed treatment, or another defined group. Nor does it report an intention-to-treat analysis, a per-protocol analysis, or sensitivity analyses. These omissions limit assessment of whether the outcome summaries preserve the advantages of randomization and how robust the results are to incomplete follow-up.

The record lists zero reported analyses. Consequently, no sponsor-reported model, missing-data procedure, or multiplicity-adjusted result is available for comparison with the unadjusted recalculations. These methods and populations are not reported in the registry record.

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 serious adverse event terms

Serious events with the highest arm-level rate: disease progression (6.7%), septic shock (6.7%).

The safety summaries list serious adverse events among 30 participants at risk in each group. In the individualized music-listening group, 3 participants were reported as affected by serious adverse events; in standard care, 2 were reported as affected. The registry also lists 1 death in the music-listening group and 2 deaths in standard care. These are descriptive counts, not evidence by themselves that an event was caused by the intervention or that group safety differs.

The most frequently listed serious event terms are Disease Progression and Septic shock, each reported as 6.7%. The record lists no other adverse events affecting participants in either group. It does not provide event timing, severity details beyond the serious-event classification, a causal assessment, or an explanation of the relationship between events and deaths. It also does not state whether individuals could contribute more than one event term.

Safety figures should be read alongside the study duration and the population being studied. The study lasted 21 days and involved patients with acute leukemia undergoing chemotherapy. The registry record does not provide enough detail to attribute the listed events to music listening or standard care, or to establish a comparative safety conclusion.

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

The posted primary summaries show a difference in mean TFRS change scores between the randomized groups over baseline to Day 21. The unadjusted recalculated difference is -40.08 points, with an interval from -66.55 to -13.61 and a p-value of 0.003. This is evidence of a statistical separation in the posted summaries under the recalculation assumptions. It is not, on its own, a complete account of the trial’s planned analysis.

The scale measures self-reported fatigue, and higher total scores indicate greater fatigue. However, the registry record does not state the direction used to calculate the change score. Therefore, the negative difference can be described arithmetically as a lower mean change score in the music-listening group, but the sign alone should not be translated into a specific amount of fatigue improvement. The record also does not report a threshold for a clinically meaningful TFRS change.

The randomized design is relevant to comparing the assigned groups, but interpretation also depends on follow-up, adherence, missing outcomes, analysis population, and statistical methods. These details are not reported in the registry record. The summary statistics do not establish whether participants listened as assigned or whether any changes in laboratory measures were caused by the intervention.

The laboratory outcomes provide additional endpoint summaries, not independent confirmation that fatigue changed in a particular way. Their unadjusted results are subject to multiplicity, and the record does not report a multiplicity strategy. Nor does it provide enough clinical context to infer the meaning of the laboratory differences.

Overall, the registry record supports a description of the observed group summaries and their recalculated statistical uncertainty. It does not establish the clinical importance, durability, or broader applicability of the fatigue result. It should not be used alone to make a treatment decision.

17. Why This Trial Matters Statistically

This trial raises a useful statistical question about how to evaluate a patient-reported outcome alongside laboratory measurements in a randomized study. The primary endpoint is a fatigue scale, whereas the secondary endpoints are laboratory values at Day 21. Keeping these domains distinct matters: statistical evidence in one type of outcome does not automatically validate an interpretation in another.

The change-score convention is especially important. The scale’s total-score direction is documented, but the registry record does not say how the change was subtracted. This prevents a complete directional interpretation of the primary contrast even though the group difference and interval are available. Clear reporting of the change definition is a basic condition for translating a numerical contrast into an understandable outcome statement.

The record also illustrates why estimates should be reported with uncertainty and in context. The primary interval conveys a range of plausible differences under the recalculation assumptions, while the p-value alone does not describe effect size or practical importance. The sample-size illustrations further show how planning targets depend on the effect size chosen, but they cannot reveal the study’s original design rationale.

Finally, the absence of a reported analysis plan, multiplicity approach, missing-data strategy, and analysis population constrains what can be concluded from the posted results. Transparent reporting of these elements would make it easier to distinguish prespecified confirmatory findings from exploratory patterns and to assess how much confidence to place in the estimates.

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 registry record leaves several trial-specific interpretive gaps. The primary endpoint is defined as change from baseline to Day 21, but the direction of subtraction is not stated. This matters because the TFRS total score is higher with greater fatigue, while a change score can have either sign convention. The result can be reported as a lower mean change score in the music-listening group, but a more specific description of change direction is not supported by the record.

The registry gives enrollment as 60, while the primary summaries include 27 and 28 participants. Safety summaries list 30 participants at risk in each group. The record does not provide a participant flow diagram or explain why these counts differ across outcomes. It is therefore not possible to determine from the registry record whether the differences reflect missing outcome measurements, exclusions, or another reason.

Although the trial is identified as randomized and double-masked, the registry record does not detail the randomization procedure or how masking was maintained. It does not describe adherence to daily music listening, the content of standard care, or the handling of treatment deviations. It also does not report baseline characteristics that would help assess the groups’ comparability in the posted outcome summaries.

The statistical plan, analysis populations, missing-data methods, and multiplicity handling are not reported, and the record lists no reported analyses. The available comparisons are unadjusted recalculations from summary statistics. The record also does not state the confidence level or interval method. The short 21-day study period limits what these results can say about outcomes beyond Day 21, and the registry does not provide a threshold for clinically meaningful fatigue change.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Individualized Music Listening in Acute Leukemia Patients With Fatigue — NCT06286332.
• Registry record last updated 2026-10-29; status last verified 2026-10.
• Results first posted 2026-01-20.
• 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

NCT06286332 is a completed randomized, double-masked, parallel-group study titled “Individualized Music Listening in Acute Leukemia Patients With Fatigue,” sponsored by Chang Gung University. The registry lists an enrollment of 60. The intervention group received self-selected app-based music listening for 30 minutes every day plus standard therapy; the comparison group received standard care. The study duration was 21 days.

The primary endpoint was change in TFRS total score from baseline to Day 21. The unadjusted recalculated mean difference was -40.08, with an interval from -66.55 to -13.61 and p = 0.003. Secondary outcomes were albumin, hemoglobin, and absolute neutrophil count at Day 21. The registry record does not report the analysis plan, change-score convention, missing-data methods, or multiplicity strategy.