Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders (NCT04208243), a na na study. The primary outcome is PedsQL 3.0 Cancer Module Scale.

2. Clinical Question

3. Trial Design

This is a completed, single-group study of Creative Arts Therapy in the Center for Cancer and Blood Disorders. The registry lists cancer as the condition and classifies CAT as a behavioral intervention. The sponsor is the University of Colorado, Denver. The registered enrollment is 83. The study phase and allocation are recorded as NA, and masking is recorded as NONE.

The described population consists of oncology patients in the outpatient unit who had not previously received more than two CAT sessions and were expected to receive approximately weekly infusions of at least one hour in the infusion center. The registry says a research assistant would identify eligible patients. This description does not establish how many patients were screened, eligible, approached, or enrolled beyond the overall registered enrollment.

The registry dates the study start to 2010-09-29 and the primary completion to 2022-01-02, with status listed as completed. Those dates do not by themselves explain the duration of each participant’s follow-up or when individual outcome measurements were collected. The primary outcome timeframe is 7 months, but the schedule of assessments and whether measurements were planned at additional time points are not reported in the registry record.

Because the study is single group and has no listed control arm, it is not a randomized comparison. The design can describe outcomes among the enrolled participants, but a comparison with a separate untreated or alternative-treatment group is not available in the registered design. The protocol’s rationale for the design, sample-size justification, recruitment targets, and any changes to the study plan 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.

Overall Study

5. Baseline Characteristics

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

6. Primary Endpoint

The registry lists the primary outcome as PedsQL 3.0 Cancer Module Scale, measured over 7 months.

The primary endpoint is the PedsQL 3.0 Cancer Module Scale, a continuous quality-of-life measure for children with cancer. The registry describes the instrument as a 27-item measure covering 8 subscales: pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication. The subscales are summed to produce a total score.

The instrument uses a 0-100 score system, with higher scores indicating a better outcome. The registry identifies the summary measure as a mean and the accompanying measure of spread as a standard deviation. In general, the mean describes the average score in a group, while the standard deviation describes how dispersed individual scores are around that average. Neither statistic is reported for this study’s primary endpoint.

The description identifies a Parent-Proxy Report for ages 2-18 years and a companion Child Self-Report for children 5 years and up. It also states that the instrument has been reported as responsive to change compared with other quality-of-life measures used with children undergoing chemotherapy. The registry describes internal-consistency reliability coefficients ranging from .80-.90 across total and individual scales and says the measure is appropriate for group comparisons. These instrument characteristics explain why the measure may be used to assess quality of life; they do not supply the study’s outcome results.

The endpoint timeframe is 7 months. The exact assessment schedule, respondent used for each participant, and observed score at that timeframe are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The primary outcome is continuous and is summarized in the registry as a mean with a standard deviation. In general, a mean is the arithmetic average of measured scores in a specified group. It gives a central summary, but does not show whether participants’ scores were tightly clustered or widely dispersed. The standard deviation describes that spread in the same units as the score. A group mean and standard deviation together offer more context than the mean alone, but they do not reveal the full distribution or individual participants’ outcomes.

For this study, neither the primary mean nor its standard deviation is reported in the registry record. The registry also does not report how many participants contributed measurements to the primary outcome summary. Consequently, the primary endpoint’s central tendency and variability cannot be described from the posted results.

How would uncertainty be assessed?

In general, a confidence interval gives a range of values compatible with the data and the statistical procedure used to construct it. Its width reflects precision: a narrower interval indicates a more precise estimate under the assumptions of that method, while a wider interval indicates more uncertainty. A confidence interval is not a range containing every individual participant’s score, nor does it remove limitations in the design or measurement.

No confidence interval for the PedsQL outcome is reported in the registry record. The sample size alone is not enough to reconstruct one. A valid interval would require the relevant outcome estimate and information about the analysis population and method. Those details are not reported. A p-value, standard error, or other inferential result for the primary endpoint is likewise not reported.

What does a single-group design allow?

The registered model is single group, with allocation recorded as NA and masking as NONE. There is no listed comparator arm. In general, random allocation to concurrent groups can help balance measured and unmeasured factors on average, while a concurrent comparison can help distinguish an intervention-associated outcome from changes shared over time. A single-group study does not have that design-based comparison.

If outcome measurements were collected repeatedly, a within-person analysis could describe how scores changed across assessment times. Such a change would still need cautious interpretation because factors other than CAT could contribute to it. The registry does not report whether a baseline score was collected, whether repeated measurements were analyzed, or what statistical model was planned. The record lists 0 analyses, so no analysis method for the primary outcome is available to evaluate.

What is the relevance of the planning illustration?

The planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrated effect is described as a stated fraction of the observed effect. These assumptions do not describe the registered single-group design, which has no two-arm comparison. The effect estimate used for the illustration is not reported in the registry record, and the planning illustration must not be read as observed power or as evidence about the outcome.

In general, sample-size calculations estimate the number of observations needed under specified assumptions about an effect, variability, allocation, and error rates. They do not show that an effect was observed, and they do not guarantee that an analysis will have the intended precision. A planning calculation based on an observed effect can be especially dependent on how that effect was estimated. The trial’s own sample-size justification and the assumptions used in its design are not reported in the registry record.

Why do distribution and measurement details matter?

A mean-based analysis is often useful for a continuous score, but its interpretation depends on the measurement process and the analysis population. In general, outlying observations can influence a mean, and a standard deviation may not fully describe a skewed distribution. The score’s bounds and its construction also matter when interpreting changes or comparing groups. The registry describes a 0-100 scale and a total score formed by summing subscales, but it does not report the observed distribution, data checks, handling of unusual values, or any transformations used in the study analysis.

Over-dispersion is a concept most often discussed for count data: it occurs when variability exceeds what a chosen count model expects. It is not a reported feature of this continuous PedsQL endpoint. More generally, model assumptions should fit the outcome and design, but the registry does not identify a fitted model or diagnostic checks for this study. No model-specific conclusion can therefore be assessed.

Finally, measurement quality and statistical uncertainty are related but distinct. The registry’s description of reliability and responsiveness concerns the instrument’s characteristics. It does not substitute for reporting the study’s actual scores, analysis population, uncertainty estimates, or methods. Those study-specific analysis details are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Oncology Patient")
n   <- c(83)
m   <- c(71.59)
sp  <- c(16.14)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Oncology Patient  83  71.590  16.140  68.066  75.114

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures and identifies the PedsQL 3.0 Cancer Module Scale as the primary outcome. It lists 0 analyses. No multiplicity procedure, testing hierarchy, or explanation of how results across the listed outcomes would be interpreted is reported in the registry record. In general, when several outcomes or hypotheses are examined, the chance of at least one apparently notable result can increase if each is assessed separately. A prespecified primary outcome can help focus interpretation, but it does not establish how other outcomes were handled.

Missing-data information is not reported. The registry does not state how many participants completed the PedsQL assessment, whether missing scores occurred, why any data might be missing, or how missing values were handled. In general, missingness can affect both the representativeness of an analysis group and the precision of estimates. Without the number and pattern of missing measurements or the analysis approach, the potential effect of missing data cannot be evaluated.

The analysis population is also not described. The registered enrollment is 83, but the registry does not state whether all enrolled participants were included in an outcome analysis or identify any subset used for analysis. No definitions for an intention-to-treat, per-protocol, or other analysis population are reported. Enrollment, exposure to CAT, follow-up completion, and inclusion in an endpoint analysis should not be assumed to be identical.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists the Oncology Patient group with 83 participants at risk for serious adverse events and 0 serious adverse events. It also lists 83 at risk for other adverse events and 0 other adverse events, with 0 deaths. No serious adverse event terms are listed.

These are the safety counts recorded in the registry. They do not describe the timing or duration of safety monitoring, the event definitions, the method of collection, or whether all enrolled participants contributed the same amount of follow-up. Those details are not reported in the registry record. The safety figures should therefore be read as registry-reported counts, not as evidence that the possibility of adverse events was absent or that all relevant events were captured.

The listed counts also do not supply a comparison with another group. Because the registered design is single group and no comparator is listed, the safety entries cannot establish a relative difference in adverse events between CAT and an alternative. No medical conclusion about risk can be drawn from these counts alone.

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

The record describes a completed study of CAT among pediatric oncology patients receiving chemotherapy, with a primary quality-of-life outcome measured using the PedsQL 3.0 Cancer Module Scale and a stated timeframe of 7 months. It also records an enrollment of 83 and lists 4 outcome measures. These details clarify the study’s focus and registered structure.

The registry does not report the primary outcome result, an analysis, or an estimate of uncertainty. It therefore does not establish how participants scored, whether scores changed, or how precise any outcome estimate might be. The absence of a reported result is not evidence that CAT had no effect; it also is not evidence that CAT improved the measured outcome. The posted information does not support either conclusion.

The single-group design further limits causal interpretation. Even if a score change were available, a change among participants receiving CAT would not, by itself, distinguish the contribution of CAT from other influences. The registry does not list a control group or randomized allocation.

The registry summary gives a rationale based on a previous pilot study and describes the outcomes the investigators hoped to evaluate. A rationale and hypothesis are not substitutes for results from this study. The actual outcome estimates, missing-data information, analysis population, and statistical methods are not reported in the registry record. Accordingly, the defensible reading is descriptive: the record documents a completed single-group study and its intended primary measure, but the posted results do not permit an assessment of the primary outcome.

14. Why This Trial Matters Statistically

This study illustrates why a clearly named endpoint and an enrollment count do not, on their own, allow a statistical conclusion. The registry identifies a continuous quality-of-life measure, a direction for interpreting its score, and a timeframe. It does not report the score distribution, a mean, a standard deviation, or an analysis. Without those outcome details, neither the size of an observed result nor its precision can be evaluated.

The design also matters. A single-group study can contribute descriptive information about participants who receive an intervention, but it does not offer a concurrent comparison for separating intervention-associated changes from other influences. This is a design limitation for causal interpretation, not a claim that the study’s observations are uninformative. How much can be learned depends in part on what outcomes were measured and reported, and those results are not available in the registry record.

Safety reporting provides a separate example of the need for context. The record lists zero serious adverse events, zero other adverse events, and zero deaths, alongside 83 participants at risk in each adverse-event category. Interpretation still depends on definitions, monitoring, and follow-up details, which are not reported.

For clinical researchers and biostatisticians, this record highlights the distinction between study status, study design, and study findings. A completed study is not necessarily a study with posted outcome analyses. A planning illustration is not a trial result, and a registry’s background rationale is not an estimate of the intervention’s effect. Clear reporting of analysis populations, outcome estimates, uncertainty, missing data, and methods is needed to make the findings statistically interpretable.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this study are apparent from the registry record. The registered design is single group, with no listed comparator and no randomized allocation. This prevents a direct between-group comparison and limits the ability to attribute any observed change specifically to CAT. Masking is recorded as NONE, and the record does not describe any procedures intended to reduce outcome-assessment or reporting bias.

The primary outcome is named and its timeframe is stated, but the registry does not report its observed mean, standard deviation, or analysis. It also lists 0 analyses. As a result, the actual primary endpoint findings cannot be evaluated. Although 83 participants are registered as enrolled, the number contributing a primary outcome measurement is not reported.

The record does not describe the schedule of assessments, baseline outcome values, completion of follow-up, missingness, analysis population, or approach to missing data. It does not identify the statistical methods used for the outcomes or any plan for handling multiple outcomes. These omissions make it difficult to assess the analysis and the potential for selective availability of results.

The intervention description is limited to the name Creative Arts Therapy and its behavioral classification. The registry does not report the specific CAT content or implementation details, which limits understanding of what was delivered. The sample-size justification, detailed study protocol, and any interim analyses are not reported in the registry record. The planning illustration assumptions do not resolve these gaps or establish the design’s achieved precision.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders — NCT04208243.
• Registry record last updated 2023-04-03; status last verified 2023-03.
• Results first posted 2022-06-10.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed, single-group study of Creative Arts Therapy in pediatric oncology patients receiving chemotherapy at the Center for Cancer and Blood Disorders. The registered enrollment is 83. Allocation is listed as NA, masking as NONE, and the study phase as NA. The sponsor is the University of Colorado, Denver.

The primary outcome is the PedsQL 3.0 Cancer Module Scale, a continuous score with a stated timeframe of 7 months. The registry lists 4 outcome measures and 0 analyses. It does not report the primary endpoint result, analysis population, missing-data handling, or statistical methods used for outcome analyses.

Safety entries list 83 participants at risk for serious and other adverse events, 0 events in each category, and 0 deaths. The record does not include details needed to assess event monitoring or follow-up. In sum, the registry documents the study’s design and intended outcome, but its posted results do not permit statistical evaluation of the primary endpoint.