Health Gatherings - For Your Health After Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Health Gatherings - For Your Health After Cancer (NCT03344757), a randomized na study. The primary outcome is Change in Symptom Burden as Measure by EPIC-S..

2. Clinical Question

The study’s broader purpose was to examine stress management in relation to quality of life, distress, depression, and physical health. Listed secondary measures include stress-management skills, prostate cancer-specific psychological distress, depression, anxiety, and interpersonal function. The registry record names these outcomes but does not report their results. The clinical question is therefore identifiable from the study description, while the available record does not provide the outcome estimates needed to judge the comparative results.

3. Trial Design

This was a randomized, double-masked, parallel-group behavioral trial. Its listed enrollment was 188, and its status is completed. The study record gives a start date of 2017-10-05 and a primary completion date of 2024-08-01. The phase is listed as NA. The sponsor was the University of Miami.

Participants were assigned to one of two group-based programs: culturally adapted cognitive behavioral stress management (C-CBSM) or standard cognitive behavioral stress management (CBSM). The arm descriptions specify 10 weekly group sessions for each program. The trial therefore compares two active behavioral approaches rather than describing a no-treatment or usual-care arm. The registry record does not explain what aspects of the culturally adapted program differed from the standard program, beyond identifying one as culturally adapted.

Randomized allocation supports a planned comparison between the assigned groups, but the record does not report the sequence-generation or allocation-concealment procedures. It identifies masking as double, without naming which people were masked or describing how masking was implemented. Details of the group-session delivery, attendance, adherence, and any departures from assigned intervention are not reported in the registry record.

Repeated primary-outcome assessments were planned at baseline, Month 3, Month 6, and Month 12. The registry record cautions that some participants did not complete every assessment or timepoint and that some were lost to follow-up. It does not describe how these incomplete observations were handled in the analyses. Although the study is marked completed, completion status alone does not supply the outcome findings or statistical comparisons. No primary-outcome estimate, uncertainty interval, or analysis result is 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: Not all participants completed every assessment/timepoint and some were lost to follow-up.

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 Symptom Burden as Measure by EPIC-S., measured over Baseline, Month 3, Month 6, Month 12.

The primary outcome is change in symptom burden measured by the 5-item sexual domain of the Expanded Prostate Cancer Index Composite - Short Form (EPIC-S). The listed assessments are baseline, Month 3, Month 6, and Month 12. Items are transformed to a 0-100 scale and averaged to form the domain summary score. Higher scores indicate better functioning and less bother, so the direction of the scale is important when interpreting any change.

This domain provides a standardized way to represent participants’ reported sexual functioning and related bother after prostate cancer. Measuring the same domain at several timepoints can describe how scores change over follow-up and whether patterns differ between randomized groups. The registry record specifies that the endpoint is summarized as a mean, with standard error as the stated measure of dispersion.

The record does not give the observed means, changes, between-group contrasts, or uncertainty estimates at the listed timepoints. It also does not report an analysis result for this endpoint. Consequently, the outcome definition and its direction can be interpreted, but the actual course of scores and the comparative result cannot be determined from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a randomized, double-masked, parallel design with two behavioral intervention arms. Randomization is intended to make assignment—not participant characteristics—the basis for group comparison. In general, random assignment can reduce systematic differences between groups at the start of a trial, although chance imbalances can still occur. The record does not describe the randomization procedure, concealment, or the characteristics of participants by arm, so those design details cannot be evaluated.

What does the primary outcome represent?

The primary outcome is a continuous score: the mean of the five EPIC-S sexual-domain items after transformation to a 0-100 scale. For a continuous measure, a group mean describes the average score in that group. The stated score direction matters: higher scores indicate better functioning and less bother. The record names standard error as the dispersion measure. In general, a standard error describes the precision of an estimated mean, rather than the spread of individual participants’ scores. No observed means or standard errors are reported in the registry record.

Change is assessed from baseline across Month 3, Month 6, and Month 12. Repeated measurements can be analyzed in several ways, including time-specific comparisons or models that use observations across time. These approaches answer related but not identical questions. The statistical model, the specific contrast used to represent change, and the handling of within-participant correlation are not reported in the registry record. It is therefore not possible to identify which method, if any, was used for the primary outcome.

How should an effect estimate and its uncertainty be read?

In general, an effect estimate expresses the size and direction of a comparison, while a confidence interval describes a range of values compatible with the data and the model’s assumptions. A narrower interval indicates greater precision than a wider interval. A p-value, in general, measures how incompatible the observed data are with a specified null hypothesis under the analysis assumptions; it does not measure clinical importance. These general concepts cannot be applied to a particular treatment contrast because the registry record does not report an estimate, confidence interval, or p-value for the primary outcome.

Mean differences are often used for continuous outcomes when groups are measured on the same scale. For repeated assessments, the meaning of a difference depends on whether it compares scores at one timepoint, changes from baseline, or an overall pattern over time. Those definitions are not interchangeable. The registry record does not specify a primary contrast beyond naming change and listing multiple assessment times. It would be inappropriate to construct an unadjusted comparison without the necessary outcome summaries.

What do the planning assumptions mean?

The sample-size planning illustration is based on the observed effect and is described as a planning exercise, not as the trial’s own design justification. It assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. In general, a two-sided test allows for a difference in either direction. Equal allocation is a planning assumption about the group sizes used in that illustration, not a claim about the actual numbers analyzed in each arm. A normal approximation is a mathematical simplification used for the planning calculation.

Such planning values are hypothetical sample-size illustrations. They do not show the probability that this completed trial detected an effect, and they are not observed-power results. The registry record does not report the protocol’s sample-size justification or establish that the illustrative assumptions governed the trial’s design. The observed effect needed to anchor the illustration is not reported in the registry record, so no numerical planning conclusion can be independently interpreted from the information recorded.

Why can over-dispersion matter?

In general, over-dispersion occurs when observed variability is greater than a model assumes. If a model understates variability, standard errors may be too small and confidence intervals too narrow, making evidence appear more precise than it is. This issue is especially relevant to outcomes whose variance is modeled rather than directly summarized. The primary endpoint in this trial is described as a continuous mean score, and the registry record does not identify an over-dispersion adjustment or a model requiring one. No claim about over-dispersion in this trial is supported by the record.

The record identifies incomplete assessments and loss to follow-up but does not state the analysis population, missing-data method, covariate adjustment, or sensitivity analyses. These choices can affect estimates and their precision. With no reported outcome analyses, statistical methods and their assumptions cannot be checked against the observed results.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is assessed at baseline, Month 3, Month 6, and Month 12, while the registry lists several secondary outcomes. Multiple timepoints and outcomes create multiple possible comparisons. In general, examining many comparisons can increase the chance of finding an apparently notable result by chance. Prespecified outcome hierarchies, adjustment procedures, or a clearly designated primary contrast can help define how such comparisons should be interpreted. The registry record does not report a multiplicity strategy, a statistical analysis plan, or which timepoint-specific contrast was designated as primary.

The record lists zero analyses and does not report outcome estimates or tests. Thus there is no reported family of findings from which to evaluate multiplicity adjustments or determine whether a result was selected from several analyses. Whether interim analyses were planned or conducted is not reported in the registry record.

Missing observations are a further concern. The record states that not all participants completed every assessment or timepoint and that some were lost to follow-up. It does not give the number with available data at each visit, reasons for missingness, or whether missingness differed between arms. The method for handling missing data—such as the use of a model, imputation, or complete-case analysis—is not reported in the registry record. These methods rely on different assumptions, so the missing-data approach is important for interpreting repeated-measures estimates.

The analysis population is also not reported. The record does not say whether the primary analysis followed randomized assignment, included only participants who attended sessions, or used another population definition. These omissions prevent assessment of how the analysis preserved the randomized comparison and how incomplete follow-up affected the reported findings. No statistical plan or sensitivity analysis is reported in the registry record.

11. 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

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: injury (1.1%), insomnia (1.1%), hypertension (1.1%).

The adverse-event record reports serious events affecting 0 of 100 participants in the C-CBSM group and 3 of 88 in the standard CBSM group. Other adverse events affected 3 of 100 and 7 of 88, respectively. Deaths are listed as 0 in both groups. These are descriptive counts as recorded; the registry record does not provide a statistical comparison or uncertainty estimates for them.

The listed top serious-event terms are Injury, Insomnia, and Hypertension, each reported as 1.1%. The record does not assign these terms to a particular intervention group in the listed terms. It also does not provide event timing, duration, severity details beyond the serious-event classification, or an assessment of whether events were related to the interventions. A serious adverse event is a reporting category and does not by itself establish that the intervention caused an event.

Group counts should be read alongside the numbers at risk recorded for each category. The registry does not explain the safety observation period or provide further detail about ascertainment. These figures describe what was recorded in the registry; they do not establish comparative safety or the absence of unreported events.

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

The registry record establishes that a randomized, double-masked, parallel trial compared 10-week group-based culturally adapted and standard cognitive behavioral stress management programs. It identifies change in EPIC-S sexual-domain symptom burden as the primary outcome and specifies the scale’s direction and assessment times. It also documents that the trial is completed and lists adverse-event counts.

It does not establish whether one program produced a larger change in symptom burden than the other. The primary outcome’s means, changes, between-group estimates, confidence intervals, and p-values are not reported in the registry record. The record also gives no analysis results for the listed secondary outcomes. A trial’s enrollment, design, and completed status cannot substitute for an estimate of the comparative effect.

Nor can the record establish how precise any possible effect estimate would be, whether outcome patterns differed across follow-up, or whether missing data altered the comparison. Those judgments require analyses and details that are not reported. The adverse-event counts are descriptive and cannot, without additional analysis and context, establish that either program caused or prevented events.

The proper reading is therefore limited but useful: the registry record defines the intended population, intervention contrast, outcome, and follow-up schedule, while leaving the comparative efficacy results unavailable. It does not support a conclusion that the culturally adapted or standard program performed better or worse on the primary endpoint. It also does not support conclusions about the secondary outcomes or causal interpretation of adverse events.

13. Why This Trial Matters Statistically

This trial raises a statistically meaningful comparison because both arms received a structured cognitive behavioral stress-management program, while one was identified as culturally adapted. A randomized design can support a comparison of assigned programs, but the result depends on the outcome definition, analysis, completeness of follow-up, and precision of the estimates. The registry record identifies the question and endpoint without reporting the analyses that would answer it.

The repeated EPIC-S assessments are relevant because symptom burden may be described at more than one point in follow-up. A single summary can obscure a changing pattern, while separate timepoint comparisons raise questions about multiplicity and how the primary contrast was chosen. The record lists baseline and three later assessments but does not report the model, contrast, or adjustment strategy. These are central interpretive details rather than technical afterthoughts.

Incomplete assessments and loss to follow-up also matter statistically. Without visit-specific data counts, an analysis-population definition, and a missing-data approach, it is difficult to assess whether the intended randomized comparison was retained over time. The absent outcome estimates further mean that precision and practical importance cannot be judged.

The record is useful for identifying the design and measures, and it makes clear that the primary scale has an interpretable direction. At the same time, the absence of reported analyses sharply limits what can be learned about comparative outcomes. This distinction—between a well-specified question and an available answer—is important when reading trial registries.

14. 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 main limitation for interpreting this trial record is the absence of primary and secondary outcome analyses. The registry identifies the primary EPIC-S measure and its schedule, but does not report means, changes, between-group contrasts, confidence intervals, or p-values. The record lists zero analyses. As a result, the magnitude and precision of comparative effects cannot be assessed.

Some participants did not complete all assessments, and some were lost to follow-up. The record does not report the number assessed at each timepoint, reasons for missingness, or methods used to account for incomplete data. This limits assessment of the repeated-measures evidence and the possibility that missingness influenced the comparisons.

The record does not describe the primary contrast, statistical model, analysis population, covariate adjustment, multiplicity approach, or sensitivity analyses. It also does not describe randomization procedures or which parties were masked. Although masking is listed as double, implementation details are not reported. The specific features that distinguish the culturally adapted sessions from standard CBSM are not described in the arm summaries.

For safety, the record provides counts and selected serious-event terms but not event timing, intervention relatedness, or a comparative statistical analysis. The safety observation period is not reported. These limitations are specific to the information recorded and should not be mistaken for evidence that the omitted procedures or analyses were not conducted; their details are simply not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Health Gatherings - For Your Health After Cancer — NCT03344757.
• Registry record last updated 2025-09-11; status last verified 2025-08.
• Results first posted 2025-09-11.
• 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.

18. Record Summary

NCT03344757, titled “Health Gatherings - For Your Health After Cancer,” is a completed randomized, double-masked, parallel behavioral trial sponsored by the University of Miami. It enrolled 188 participants and compared culturally adapted C-CBSM with standard CBSM, each described as 10 weekly group-based sessions.

The primary outcome was change in EPIC-S sexual-domain symptom burden at baseline, Month 3, Month 6, and Month 12. Higher scores indicate better functioning and less bother. The record notes incomplete assessments and loss to follow-up, but does not report outcome analyses, analysis populations, or missing-data methods. Serious adverse events affected 0 of 100 participants in the culturally adapted arm and 3 of 88 in the standard arm; deaths were listed as 0 in both arms. The registry record describes the trial question but does not report comparative outcome estimates.