Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19 (NCT04747249), a na na study. The primary outcome is Proportion of Patients With Improvement in Post-traumatic Stress Symptoms.

2. Clinical Question

In statistical terms, this is a within-group outcome question: the record specifies a measure of change relative to baseline, rather than a contrast between an intervention group and a control group. That distinction matters when interpreting any reported change. Without a concurrent comparator, the record cannot separate changes associated with the support from changes over time or other influences. The registry entry lists 29 participants enrolled, but it does not report how many contributed data to the primary outcome or the number who met the improvement definition.

3. Trial Design

The registry lists this as a completed, single-group study of psychological support for oncology patients with post-traumatic stress in the context of COVID-19. It records 29 participants enrolled. The intervention is described as monthly psychological support. The primary outcome was assessed at 6 months, and resilience scores are listed as a secondary outcome. The registry record does not report further details about how often participants received support, the length of the intervention, or the timing of the secondary outcome.

Allocation is recorded as not applicable, consistent with the single-group design; masking is listed as none. There is no control group for comparison. Consequently, the design can describe outcomes among participants who received the support, but it does not estimate a controlled difference between support and another intervention or usual care. The record identifies the study as completed, with a start date of 2021-06-18 and a primary completion date of 2022-03-31.

The study is listed with phase not applicable. The registry record does not report a sample-size justification, a recruitment target rationale, or a statistical analysis plan. It also does not report whether there were interim analyses, how participants were selected for analysis, or how missing outcome data were handled. These omissions limit assessment of whether the planned design and analysis were adequate for the stated question. Enrollment alone does not establish how many participants were included in an outcome analysis.

Planning illustrations associated with the record use assumptions for two arms with equal allocation, even though this trial is recorded as single-group. Those illustrations are not the study’s design and should not be read as observed power or as evidence of a comparison that the trial did not conduct. Their assumptions describe hypothetical planning calculations based on an observed effect; the registry record does not report the effect value or a trial-specific sample-size justification.

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: Patients aged ≥18 years, treated or followed for a solid tumor at Centre François Baclesse, and presenting moderate to high post-traumatic stress symptoms (score ≥24 on the Impact of Event Scale-Revised (IES-R)) related to the COVID-19 epidemic.

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: All patients included were described at baseline

6. Primary Endpoint

The registry lists the primary outcome as Proportion of Patients With Improvement in Post-traumatic Stress Symptoms, measured over 6 months.

The primary endpoint is the proportion of patients with improvement in post-traumatic stress symptoms, with the registry outcome also described as a count of participants. Assessment was at 6 months. Improvement was defined as a decrease below the threshold of 24 on the Impact of Event Scale-Revised (IES-R) compared with baseline.

The IES-R is a 22-item self-report questionnaire covering intrusion, avoidance, and hyperarousal. Its total score ranges from 0 to 88, with higher scores indicating greater symptom severity. Using a stated threshold makes the endpoint a classification of whether a participant meets the specified improvement definition, rather than simply reporting a change in the total score. The record does not provide the number of participants who met that definition, the number assessed, or a result estimate.

As a general statistical point, a threshold-based endpoint can be straightforward to interpret as a count or proportion, but it compresses the scale’s range into a category. Participants close to a threshold may be classified differently from those farther from it despite similar score changes. A continuous score analysis could retain more detail about the size and distribution of change, but the registry record does not report such an analysis for the primary outcome. The endpoint is relevant to the study’s stated focus on post-traumatic stress symptoms; its observed result and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is the primary endpoint?

The primary endpoint is expressed as a count or proportion of participants meeting a stated improvement definition. Each participant is classified according to whether the IES-R criterion was met at the 6-month assessment relative to baseline. This is a binary outcome for analysis: the criterion is either met or not met. The registry record does not report the observed count, the denominator assessed, or an analysis estimate.

As a general statistical explanation, a proportion describes the share of an analyzed group meeting a condition. Its interpretation depends on knowing both the count meeting the condition and the number evaluated. If some participants lack an assessment, the choice of denominator and the handling of missing measurements can affect the estimate. Those details are not reported in the registry record, so an outcome proportion cannot be reconstructed from enrollment alone.

What would an uncertainty interval mean?

As a general statistical explanation, a confidence interval describes a range of values compatible with the data and a specified method, reflecting sampling uncertainty. A narrow interval indicates greater precision than a wide interval, but neither an interval nor a point estimate is reported for this primary endpoint. Without those results, the precision of the estimated proportion cannot be assessed. An interval would not by itself resolve the limitations of the single-group design; it would describe uncertainty around an estimate, not establish a causal effect.

Why does the design affect the analysis?

This study is listed as single-group, with allocation not applicable and no masking. Its primary outcome compares a participant’s status with baseline, rather than contrasting outcomes in randomized groups. As a general statistical point, a within-group change and a between-group treatment contrast answer different questions. A within-group result can summarize observed change, while a controlled contrast can account for changes shared by groups under the conditions of the study. The registry record has no control group and reports no primary estimate, so neither a comparative effect nor its precision is available.

Masking is listed as none. For a self-report outcome, awareness of participation and expectations can be relevant to how responses are generated; however, the record does not describe measurement procedures or assess such influences. This is a general consideration, not evidence that responses were biased in this study.

What do the planning assumptions represent?

The registry’s planning assumptions describe an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not a report of the trial’s own design: the study itself is recorded as single-group. The record does not provide the calculated planning values or an effect estimate from which they were derived. These illustrations should not be interpreted as observed power, as a sample-size justification for this study, or as evidence of a two-arm comparison.

As a general statistical explanation, a significance level is a threshold used in a specified testing procedure to control the chance of a false-positive result under its assumptions. A two-sided procedure considers departures in either direction. A normal approximation uses a normal distribution to approximate the sampling behavior of an estimate or test statistic. Whether those choices are appropriate depends on the analysis, sample size, and data structure; the registry record does not report a trial-specific analysis plan that would allow those choices to be evaluated.

The planning assumptions refer to fractions of an observed effect. A planning calculation based on an effect size is not itself evidence that the effect was observed or reliably estimated. It is a hypothetical way to explore what sample size might be needed under stated assumptions. The registry record does not state a prospective sample-size rationale, and the planning assumptions should not be mistaken for one.

What statistical details are unavailable?

The registry record lists 0 analyses. That means no analyses are listed in the record; it does not establish that no analyses were conducted. The analysis method for the primary endpoint, any adjustment for baseline values or other factors, and any inferential test are not reported in the registry record. The record also does not report confidence intervals, p-values, subgroup analyses, or sensitivity analyses for the primary endpoint. No specific statistical model can therefore be attributed to the study from the registry entry.

In general, over-dispersion matters when observed variability is greater than a statistical model expects. It can make standard errors too small if a model fails to account for that extra variation. This concept is often relevant to count outcomes, but the primary endpoint is specified as a participant count or proportion, and the record does not report a model or data distribution that would support a claim about over-dispersion in this study. Statistical methods should therefore be interpreted only to the extent they are actually documented.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Psychological Support")
n      <- c(22)
events <- c(12)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Psychological Support  22  12  54.5  32.2  75.6  34.7  73.1  34.5  73.2

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary outcome and resilience scores as a secondary outcome. It does not report a multiplicity plan, such as whether any adjustment was planned for examining more than one outcome or more than one analysis. Without that information, the handling of multiple statistical questions cannot be assessed. The record lists 0 analyses, but this does not establish that no analyses took place; it indicates that analyses are not listed in the registry record.

Missing-data methods are not reported. The record does not state how many participants completed the 6-month assessment, whether any baseline or follow-up IES-R measurements were missing, or how missing values were treated. It also does not describe imputation, exclusions, or sensitivity analyses. These details matter because an analysis based only on participants with available measurements can represent a different group from all participants enrolled, particularly if availability of measurements is related to outcomes.

The analysis population is not reported. The registry does not specify whether the primary endpoint was evaluated among all enrolled participants, those who received support, or those with outcome measurements. The record also does not report an interim-analysis plan, a statistical analysis plan, or a sample-size justification. These absences should not be interpreted as proof that such plans or procedures did not exist; they are not reported in the registry record.

With no reported endpoint results, analysis denominator, missing-data approach, or multiplicity strategy, the robustness of any outcome finding cannot be evaluated from the registry entry. These are reporting limitations, not evidence that a particular analysis was biased or that missing data occurred.

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

The registry record establishes that a completed, single-group study evaluated monthly psychological support and specified improvement in post-traumatic stress symptoms at 6 months as its primary outcome. It also identifies resilience scores as a secondary outcome. It does not report the result for either outcome. The record therefore does not show how many participants improved, the size or precision of any change, or whether resilience scores changed.

Even if a within-group improvement result were available, its interpretation would be descriptive of change in the observed participants. In general, a before-and-after comparison without a concurrent control group cannot distinguish changes associated with an intervention from changes over time, other care, or other influences. The registry record does not provide a controlled comparison, and it cannot establish a treatment effect relative to another approach.

The primary endpoint uses a threshold on the IES-R, a self-report measure of intrusion, avoidance, and hyperarousal symptoms. Meeting the stated improvement definition would indicate that the specified threshold criterion was met; it would not, by itself, describe the full pattern of scores or the experience of every participant. The registry record does not report individual scores, outcome denominators, or results, so even this limited description cannot be applied to observed participants from the available entry.

The adverse-event entry lists 2 deaths in the Psychological Support group, with 0 recorded for participants at risk and affected for serious and other adverse events. The record does not provide causes, timing, intervention relationship, or comparison data. These details do not support a conclusion about whether the intervention caused, prevented, or had no relationship to any event.

In short, the registry entry documents a study design and intended outcome, not a result that can establish benefit, lack of benefit, or comparative safety. The completed status alone does not fill the gap in reported analyses.

13. Why This Trial Matters Statistically

This study raises a useful statistical distinction between describing change and estimating a comparative effect. The primary endpoint is defined relative to baseline, which can capture whether participants cross a stated symptom threshold over the assessment period. But the single-group design offers no concurrent reference group. That limits what can be inferred about why an observed change occurred, even if outcome results were reported.

The endpoint also illustrates how a continuous symptom measure can be converted into a binary classification. That can make a result easier to express as a count or proportion, while concealing variation in score changes and the distance of participants’ scores from the threshold. The IES-R’s 22 items cover intrusion, avoidance, and hyperarousal, but the registry’s primary definition focuses on the threshold-based improvement classification. The record does not report results for the underlying score or the resilience outcome.

Reporting is important to statistical interpretation. Enrollment is recorded as 29, yet the number assessed for the primary endpoint, the analysis population, and the outcome result are not reported. Without those elements, neither the estimated frequency of improvement nor its precision can be assessed. The absence of an analysis plan, missing-data methods, and a multiplicity strategy in the registry entry also leaves important aspects of the analysis unclear.

Finally, the planning assumptions describe a hypothetical two-arm calculation while the registered study is single-group. Keeping planning illustrations separate from the trial’s actual design prevents confusion between a hypothetical sample-size exercise and a completed comparative analysis. The statistical value of the record is therefore in clarifying the question and design while also showing which information is needed for a sound interpretation of results.

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 most important trial-specific limitation is the single-group design. Allocation is not applicable, and no control group is listed, so the study does not provide a concurrent comparison. A change from baseline, if reported, would not on its own distinguish intervention-associated change from other changes over time.

The registry record reports enrollment of 29 participants but does not report the number assessed for the primary outcome or the number analyzed. It also does not report the primary outcome result, confidence interval, or other estimate of precision. Without those results, the extent and uncertainty of any observed improvement cannot be evaluated. The secondary resilience outcome is named, but its result is also not reported.

The outcome is defined using a threshold on a self-report scale. The registry describes the instrument and its domains, but does not report score distributions, the number with missing scores, or how missing measurements were handled. The analysis population, statistical analysis plan, and multiplicity approach are not reported. These omissions limit assessment of the analysis and its robustness.

The intervention is described only as monthly psychological support. Further details about its content, duration, delivery, and adherence are not reported in the registry record. Masking is listed as none. The adverse-event entry lists 2 deaths, but the record does not report their timing, causes, or relationship to the intervention. These limitations do not establish that any particular outcome or bias occurred; they describe what cannot be assessed from the registry information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19 — NCT04747249.
• Registry record last updated 2026-07-31; status last verified 2026-07.
• Results first posted 2026-06-24.
• 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

The registry lists NCT04747249 as a completed, single-group study titled “Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19.” Centre Francois Baclesse is named as sponsor. Enrollment was 29; the recorded start date is 2021-06-18 and the primary completion date is 2022-03-31.

The intervention was monthly psychological support. The primary outcome was the proportion, also described as a participant count, with improvement in post-traumatic stress symptoms at 6 months, defined using the IES-R and a threshold of 24 compared with baseline. Resilience scores are listed as a secondary outcome. Allocation is not applicable, masking is none, and the study model is single-group.

The registry record does not report primary or secondary outcome results, an analysis plan, missing-data methods, or an analysis population. Adverse-event entries list 2 deaths in the Psychological Support group; further details are not reported in the registry record.