Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer (NCT03993054), a na na study. The primary outcome is Change in General Stress.

2. Clinical Question

3. Trial Design

This was a completed, single-group study of a culturally tailored, web-based cognitive behavioral stress management intervention for Latino sexual minority men living with HIV and cancer. The registry lists enrollment of 16 and describes a single-group pre-post design. Participants were to receive the intervention over 10 weeks. The primary outcome timeframe was also 10 weeks.

The design means that the main intended comparison was each participant’s stress measure at baseline against their measure at follow-up. This is different from a randomized comparison, in which outcomes are compared across groups assigned to different conditions. The registry lists allocation as NA and describes the model as single group; it does not identify a control arm. Accordingly, the tables and plots should not be read as if they establish a contrast between intervention and control.

The study description calls this a one year project to develop and test the intervention and says community partners were included in the research process. The registry lists the study as completed, with a start date of 2023-01-09 and primary completion date of 2024-07-12. These dates describe the registry record; they do not provide details about when individual participants entered or completed the intervention.

The registry lists phase as NA and masking as none. It does not report further details about the recruitment process, visit schedule, adherence, or how baseline and follow-up observations were handled. The study’s protocol, including any planned statistical methods beyond the stated change-from-baseline outcome, is not reported in the registry record. The absence of a comparison group is central to interpreting any change: even a precisely measured within-group change would not, on its own, show what would have happened without the intervention.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Sixteen adults signed informed consent form and were allocated to the intervention. PI removed one from the study for providing false information.

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: Sixteen adults signed an informed consent form and were allocated to the intervention. The principal investigator removed one participant from the study and its analysis for providing false information.

6. Primary Endpoint

The registry lists the primary outcome as Change in General Stress, measured over 10 weeks.

The primary endpoint was change in general stress, measured using the Perceived Stress Scale (PSS). The registry describes a 10-item questionnaire whose item responses are summed to produce a score from 0 to 40. Higher scores indicate greater perceived stress. The outcome was defined as change from baseline, with the primary timeframe listed as 10 weeks.

A repeated measure of perceived stress can describe whether scores in this group changed over the study period. A summed scale provides a quantitative measure that can be compared across time, while the score’s direction gives a straightforward interpretation: higher PSS values correspond to greater perceived stress. The registry does not describe a threshold for a meaningful change, or how the PSS was administered beyond the information above.

For this endpoint to be interpreted fully, readers would need the baseline and follow-up summaries, the estimated change, and information about its variability and uncertainty. Those results are not reported in the registry record. The outcome definition alone therefore explains what the study intended to measure, but it does not establish whether scores changed or how precisely any change was estimated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a change-from-baseline outcome represent?

In general, a change-from-baseline outcome summarizes how a measurement differs between an initial assessment and a later assessment. Here, the registry defines the primary outcome as change in general stress on the Perceived Stress Scale, with the later assessment at 10 weeks. The score is based on 10 items and ranges from 0 to 40; higher scores indicate greater perceived stress. The registry does not report the numerical change or its direction.

Change scores can be summarized by a mean and a standard deviation when the measure is treated as continuous. The mean describes the average change across the analyzed observations. The standard deviation describes how spread out individual changes are around that average. These summaries answer different questions: an average can be near a particular value even when individual changes vary widely. The registry identifies mean and standard deviation as the type of outcome and dispersion, but does not post their values.

What would uncertainty tell a reader?

In general, a confidence interval gives a range of values compatible with the data and the statistical method used, subject to the method’s assumptions. A narrow interval indicates a more precise estimate than a wide interval. A confidence interval does not show every possible source of uncertainty, and it cannot repair limitations in the study design or measurement process.

No confidence interval for the primary change is reported in the registry record. There is also no posted estimate to assess against a confidence interval or statistical test. The record therefore does not allow a reader to evaluate the precision of the primary outcome estimate. It would not be appropriate to infer precision from the enrollment alone, because the analyzed sample size and the variability of participant changes are not reported.

Why does the single-group design affect interpretation?

In general, repeated measurements in one group can describe changes observed over time, but they do not provide the same counterfactual comparison as a control group. A control group can help account for changes that might have occurred over the same period without the intervention, depending on how the study is designed and conducted. In this study, the registry describes a single-group pre-post design and no like-for-like control comparison.

Consequently, even if a within-group change were posted, it would describe change in the observed group and would not, by itself, establish that the intervention caused the change. The registry record does not describe a randomized comparison, and the analysis count is zero. The study’s description and completed status do not supply a missing comparison or an unreported analysis.

How should the planning illustrations be read?

The sample-size section uses planning assumptions: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are assumptions for planning illustrations, not evidence that this single-group study had two arms. They also do not represent the trial’s own reported design justification; that justification is not reported in the registry record.

In general, a sample-size calculation estimates how many observations a hypothetical design would need under specified assumptions. Its result depends on the target effect, variability, significance level, allocation, and analysis method. A planning calculation is not an observed result and is not observed power. It should not be read as a probability that the completed study detected an effect. The illustrations are distinct from the actual enrollment of 16 and from the unreported primary outcome analysis.

What can be said about analysis choices?

The registry says the endpoint was analyzed as change from baseline and identifies a continuous outcome summarized by a mean with standard deviation. Other details of the statistical method are not reported in the registry record. In particular, the record does not state how missing observations were handled, whether the outcome model adjusted for other variables, how assumptions were assessed, or whether an alternative analysis was planned.

General statistical practice distinguishes a prespecified analysis from an analysis chosen after observing data, because choices made after seeing results can affect interpretation. The registry information does not allow readers to assess that distinction. It also does not report an interim analysis plan or a sample-size justification, so neither should be inferred from the planning illustrations.

Because no primary estimate or analysis output is posted, the methods information supports explanation of the intended endpoint and broad design only. It cannot support a reconstruction of the analysis or an independent recalculation. If a sponsor analysis were posted alongside a recalculation, the sponsor’s own analysis would take precedence when the two differed; no such analysis is reported.

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("Culturally-tailored CBSM")
n   <- c(15)
m   <- c(-1.8)
sp  <- c(10)
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  Culturally-tailored CBSM  15  -1.800  10.000  -7.338  3.738

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, while the primary outcome is change in general stress on the Perceived Stress Scale. Results and analysis details for the other outcomes are not reported in the registry record. The record lists zero analyses, so it does not provide a collection of outcome-specific tests that could be reviewed for statistical significance.

Multiplicity refers, in general, to the interpretive problem that can arise when several outcomes, timepoints, subgroups, or statistical tests are examined. If many tests are considered, the chance of at least one apparently notable result can increase. A prespecified approach may address this issue, but the registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a detailed statistical analysis plan. It would be inappropriate to assume that an adjustment was or was not performed outside the information recorded.

Missing data are also relevant for a pre-post endpoint. A participant needs measurements at the relevant times, or a specified analysis method, for their change to contribute to an estimate. The registry records enrollment of 16 but does not report how many participants had baseline and 10-week PSS data, whether any follow-up measurements were missing, or how missingness was handled. The analyzed population and any exclusions are not reported in the registry record.

These gaps limit assessment of both the analysis population and the robustness of any result. They do not establish that data were missing or that an inappropriate method was used; they mean that the registry entry does not report this information. Readers should distinguish the recorded enrollment from the unreported number included in an endpoint analysis.

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 adverse-event figures in the registry record are counts for the Culturally-tailored CBSM group. The record lists 16 participants at risk for serious adverse events and zero participants affected by a serious adverse event. It also lists 16 participants at risk for other adverse events and zero participants affected by other adverse events. The death count is zero. No serious adverse-event terms are listed.

These are the posted counts, not a guarantee that no adverse events occurred in circumstances outside the registry’s definitions or reporting. The entry does not provide additional details about event collection, attribution, timing, or severity categories beyond the serious and other adverse-event fields. A zero count should therefore be read as no affected participants recorded in these fields, rather than as proof that the intervention has no risks.

The record describes one group and does not include a control-group safety comparison. It also does not provide event-level narratives or further safety analyses. These figures describe what the registry reports for the study; they do not establish whether events were caused by the intervention.

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

This registry record tells readers that a culturally tailored, web-based cognitive behavioral stress management intervention was studied in Latino sexual minority men living with HIV and cancer. It describes a single-group pre-post design, an enrollment of 16, a 10-week intervention, and a primary stress outcome measured with the Perceived Stress Scale. It also records zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths in the listed fields.

What the record does not show is the primary outcome result. It gives no baseline or follow-up PSS summary, no change estimate, and no measure of uncertainty or statistical test. Therefore, the registry information does not establish the direction or size of any change in stress. It is not possible to determine from this entry whether the observed change was precise or whether it would meet any criterion for statistical or practical importance.

Even a reported change in this design would be a change observed within a single group. Without a comparison group, it would not by itself establish that the intervention caused the change. This does not negate the value of documenting the study’s question, delivery approach, and outcome; it sets a boundary on what can be concluded from the design and posted results.

The safety counts should likewise be read narrowly as registry counts, not as a broad claim about safety. The record contains no comparative safety data and no event descriptions beyond the reported counts. The planning illustrations on the page are not trial findings or observed power, and they do not fill the gap left by the unreported endpoint analysis.

In sum, the record is informative about the study’s population, intervention, design, and intended measurement, but not about the primary outcome estimate. Any conclusion about the intervention’s effect on stress would go beyond what is reported in the registry record.

14. Why This Trial Matters Statistically

Statistically, this study illustrates the difference between a well-defined question and a reported answer. The registry identifies a population, an intervention, a primary endpoint, and a 10-week timeframe. It also specifies how perceived stress was measured and the direction of the scale. Those details help readers understand what the study set out to assess.

At the same time, the record lists zero analyses and does not report the primary change estimate or its variability. Without those results, readers cannot assess effect size or precision. This is an important distinction for clinical research: a completed study and a clearly stated endpoint do not necessarily mean that the endpoint analysis is available in the registry record.

The single-group pre-post design is also statistically important. It can describe within-group change, but it cannot make a direct intervention-versus-control comparison. This difference helps prevent an overly causal reading of changes over time. The study’s focus on a population described as experiencing health disparities also makes transparent reporting valuable: clear estimates, uncertainty, and analysis populations would let readers assess what the data can and cannot say about this specific group.

Finally, the entry shows why planning calculations must be kept separate from observed evidence. The sample-size illustrations use stated assumptions and are not the study’s own reported justification or observed power. Together, these features make the record useful for understanding the design and endpoint, while also showing why outcome reporting and analysis details are necessary for statistical interpretation.

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.

The main limitation for interpreting this registry entry is that the primary outcome analysis is not reported. The record defines change in general stress and gives the PSS scoring range, but it does not give a change estimate, baseline or follow-up summaries, dispersion, confidence interval, or test result. The number included in an endpoint analysis is also not reported, so the recorded enrollment cannot be assumed to equal the analysis population.

The single-group pre-post design offers no concurrent control group for comparison. As a result, a within-group change, if reported, would not by itself distinguish an intervention-related change from other changes over time. The registry lists allocation as NA and describes a single-group model; it does not report randomization or a comparator.

The registry record does not report detailed eligibility criteria, participant characteristics, recruitment information, adherence, missing-data handling, an analysis plan, multiplicity procedures, or a sample-size justification. It lists four outcome measures, but details of the remaining outcomes are not available in the information. These are limits on what readers can assess from this record; they do not establish that the study failed to address these matters elsewhere.

Finally, the adverse-event fields provide counts without event narratives or comparative data. The sample-size illustrations are planning exercises based on stated assumptions and should not be mistaken for trial findings. Taken together, these limitations mean the record supports a description of the study but not a conclusion about the primary outcome’s result or causal effect.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer — NCT03993054.
• Registry record last updated 2025-06-02; status last verified 2025-05.
• Results first posted 2025-06-02.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed, single-group pre-post study of culturally tailored, web-based cognitive behavioral stress management for Latino sexual minority men living with HIV and cancer. Enrollment was 16. The intervention was described as lasting 10 weeks, and the primary outcome was change in general stress at 10 weeks, measured using the 10-item Perceived Stress Scale, scored from 0 to 40 with higher scores indicating greater perceived stress.

The registry does not report the primary outcome analysis; it lists zero analyses. The record does not provide an estimated change, uncertainty interval, or test result. It also records zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths. The study design and endpoint can be described, but the primary result cannot be interpreted from the registry record.