Managing Distress in Malignant Brain Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Managing Distress in Malignant Brain Cancer (NCT05087095), a na na study. The primary outcome is Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains.

2. Clinical Question

The registry lists the primary measure at four months and specifies a mean and standard deviation as the planned summary. Higher ratings mean greater applicability. The four domains address symptom management and communication with healthcare providers; personal relationships; meaning and purpose; and the future, hope, and mortality.

The central statistical question is descriptive: what ratings did participants give to the domains, and how variable were those ratings? The registry record does not report the numerical ratings, mean, standard deviation, or a statistical estimate of adaptation needs. It therefore does not establish which domain was considered most applicable or whether any domain called for adaptation.

3. Trial Design

This was a completed, single-group behavioral study sponsored by Virginia Commonwealth University. The registry lists 13 participants enrolled. It records the start date as 2022-03-23, the primary completion date as 2023-11-01, and the study status as completed. The phase is listed as NA.

All participants were assigned to the CALM intervention; there was no control arm. Allocation is listed as NA, and masking as none. This is not a randomized comparison, so the design cannot estimate a difference between CALM and an alternative intervention or usual care. Enrollment alone does not establish how many participants completed each assessment or contributed data to the primary endpoint.

The intervention description says CALM therapy was delivered by telehealth. Participants were to complete surveys through a secure email link after sessions, after the intervention, and at 90-day follow-up. Exit interviews were to be conducted by phone. The primary endpoint is tied to ratings collected at the exit interview, with a four-month timeframe in the registry.

The brief study summary states that the purpose was to identify potential adaptations of CALM for service members, Veterans, their beneficiaries, and civilian populations with cancer metastasis to the brain. That purpose is consistent with an acceptability or applicability assessment, rather than a controlled efficacy comparison. The registry record does not report the detailed intervention schedule, the number of sessions, the criteria for completing treatment, or whether every participant received the same intervention exposure.

Details of the recruitment process, study locations, participant characteristics, and analysis population are not reported in the registry record. The record also does not describe a formal comparator, randomization procedure, or masking procedure beyond the listed design fields. These absences limit what can be inferred about representativeness, treatment fidelity, and the context in which the ratings were collected.

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 Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains, measured over 4 Months.

The primary endpoint asks participants to rate the applicability of the four CALM domains at an exit interview. Each domain is rated on a Likert scale from 1 (not applicable) to 5 (very applicable), and higher scores indicate greater applicability. The domains cover symptom management and communication with healthcare providers, changes in personal relationships, meaning and purpose, and the future, hope, and mortality. The registry specifies a mean and standard deviation as the endpoint summary and gives a four-month timeframe.

This measure is relevant to the stated aim of identifying potential adaptations: domain ratings can describe whether participants see the topics as pertinent to their circumstances. They do not, by themselves, show that the intervention changed distress, improved health, or caused any other outcome. Nor do ratings alone specify what adaptation should be made; interpretation would also depend on participants’ explanations and the qualitative content of exit interviews.

The registry record does not report the actual ratings, the mean or standard deviation, or separate numerical results for each domain. It also does not describe a threshold for deciding that a domain is sufficiently applicable, or a rule for combining domain ratings into an overall score. Thus, the endpoint definition is available, but the observed endpoint findings are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the planned mean describe?

For a continuous outcome, the mean is the arithmetic average of the observations included in the analysis. In this study, the registry names the mean as the primary endpoint parameter and identifies the observation as a rating of applicability. If all four domains are assessed separately, each domain’s mean would describe the average rating for that domain among participants whose ratings were included. The registry record does not say whether the primary result was intended to be a separate mean for each domain, one combined mean, or both.

A mean is useful because it gives a compact description of the overall level of responses. Its limitation is that it can conceal differences among participants. For example, a mean does not reveal whether most responses were similar or whether ratings were spread across the scale. The standard deviation, also specified in the record, is a companion description of dispersion: a larger standard deviation indicates more spread around the mean, while a smaller one indicates greater concentration. No observed mean or standard deviation is reported in the registry record, so neither the average rating nor its variability can be interpreted.

How should a Likert rating be understood?

The endpoint uses a five-point Likert scale from 1 (not applicable) to 5 (very applicable). As a general statistical consideration, individual Likert responses are ordered categories: a higher response expresses greater applicability, but the numerical labels do not necessarily guarantee equal distances between adjacent categories. Reporting a mean treats the scale values as if their spacing can be summarized numerically. That can be a practical descriptive choice, but it should be read alongside the scale definition and, where available, the distribution of individual responses. The registry record does not report response distributions or alternative summaries such as the frequency at each rating.

The four domains represent distinct topics. A mean for one domain cannot automatically stand in for the others, because participants may regard each topic differently. Any combined score would require a stated scoring rule and a rationale for treating the domains together. Such a rule is not reported in the registry record.

What can uncertainty estimates add?

In general, a confidence interval describes a range of values compatible with the data and a specified statistical procedure. It communicates uncertainty in an estimate, rather than the spread of individual participants’ responses. A standard deviation describes participant-level variation; a confidence interval for a mean describes uncertainty about the mean. They answer different questions. The registry specifies the mean and standard deviation as the planned endpoint summaries but does not report a confidence interval or other uncertainty estimate for the endpoint.

For a small study, uncertainty can be substantial, and descriptive results may be sensitive to the particular participants with available data. That is a general consideration, not a numerical finding about this study. The enrollment was 13, but the endpoint analysis count is not reported in the registry record, so the precision of any estimate cannot be established.

Why does the design matter for inference?

In general, a controlled comparison can help distinguish an intervention-associated difference from changes that might have occurred for other reasons. This study is listed as single-group and has no comparator, so its primary endpoint is descriptive rather than a between-group treatment effect. A participant’s rating at an exit interview indicates their reported view at that time; without a control group or a reported baseline rating, the design cannot isolate a change caused by the intervention.

The study is also unmasked. This means the registry does not describe masking of participants or study personnel. For a subjective rating, expectations and the context of the interview can be relevant in general, but the registry record does not report whether or how these influences were assessed. No claim about their actual effect on the ratings can be made.

What does the planning illustration represent?

The registry describes sample-size assumptions for a planning illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Those assumptions describe a hypothetical two-arm planning framework, whereas the registered study is single-group and has no like-for-like control comparison. They should not be interpreted as the trial’s own design or as evidence that the study had a particular probability of detecting an effect.

Sample-size planning illustrations are not observed power. They do not establish what the study found, whether an endpoint result was statistically significant, or whether an estimate is precise. The record does not report a trial-specific sample-size justification, the effect used in the illustration, or a numeric sample-size result. Those items are not reported in the registry record.

The registry lists six outcome measures and zero analyses. The existence of outcome measures does not itself establish that results were analyzed or reported. The listed count of analyses is not a substitute for a prespecified statistical analysis plan, which is not reported in the registry record. The endpoint definition and summary measure can be described, but the specific inferential procedures, model details, and any adjustments cannot be inferred.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and zero analyses. It identifies a primary endpoint, but the registry record does not report a statistical analysis plan describing how the primary endpoint would be prioritized in analysis or how the other outcome measures would be handled. The number of planned or applied hypothesis tests, any multiplicity adjustment, and any hierarchy among outcomes are not reported in the registry record.

As a general statistical matter, multiplicity arises when several outcomes or comparisons are examined. The more questions assessed, the greater the chance that at least one result may appear noteworthy by chance if tests are interpreted without accounting for the number of analyses. This does not establish that such a problem occurred in this study: the registry record lists zero analyses and does not report inferential results. It means the approach to multiplicity cannot be evaluated from the registry information.

The record describes surveys at several stages, including after sessions, after the intervention, and at 90-day follow-up. The primary endpoint, however, is associated with the exit interview and a four-month timeframe. The registry record does not explain whether ratings at other timepoints were analyzed, whether repeated measurements were planned, or how results from different timepoints would be distinguished.

Missing-data procedures are not reported in the registry record. It does not give the number of participants who completed the exit interview or the endpoint, explain how incomplete domain ratings would be handled, or state whether any imputation or sensitivity analysis was planned. The analysis population is also not reported. Therefore, the enrolled total of 13 should not be assumed to be the number contributing to the primary endpoint.

These omissions matter for interpretation because the number and characteristics of participants with observed endpoint data affect how representative a summary may be. The record does not allow an assessment of whether missingness was limited, whether it differed across participants, or how it might have affected results.

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.

The registry lists 13 participants at risk in the CALM group for serious adverse events and 0 participants affected by a serious adverse event. It also lists 13 at risk for other adverse events and 0 affected. The death count is 0. These are the counts recorded for the group; they are not estimates of comparative safety because there is no control group.

“At risk” indicates the number of participants included in the registry’s accounting for the relevant category. “Affected” is the count recorded as having the event. A count of 0 affected means that no participants are listed as affected in that category in the registry record; it should not be expanded into a claim about unrecorded events or about risks outside the study’s reporting.

The registry does not list serious adverse-event terms. The observation period used for these safety counts, the definitions applied to event categories, and the completeness of event ascertainment are not reported in the registry record. The listed counts should therefore be read as registry-reported counts, not as proof that an event was impossible or that a broader population would have the same experience.

Because the study enrolled 13 participants and had no comparator, the counts offer limited descriptive information and cannot establish a relative risk. They also do not answer the primary question about the applicability of the CALM domains, which is a separate outcome.

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

The registry record describes a study intended to identify potential adaptations of the CALM intervention for service members, Veterans, their beneficiaries, and civilian populations with cancer metastasis to the brain. Its primary endpoint was designed to capture how applicable participants found four CALM domains, using ratings from 1 (not applicable) to 5 (very applicable) at an exit interview. This is a participant-reported assessment of relevance, not a direct measure of treatment benefit.

The numerical primary endpoint results are not reported in the registry record. Without the ratings or their summary, the record cannot show the average perceived applicability, how varied participants’ views were, or whether one domain was rated differently from another. It also does not report a statistical estimate of adaptation needs or describe what adaptations, if any, were identified.

The study’s single-group design also sets an important boundary on interpretation. There is no control group against which to compare ratings, and the registry record does not report a baseline value for the primary measure. Thus, the design does not estimate a treatment effect or establish that any change in a participant’s circumstances was caused by CALM. An exit-interview rating, if reported, would describe participants’ reported views at that assessment.

The enrollment of 13 and the completed status describe the registered study, but do not establish that all enrolled participants completed the intervention or provided endpoint data. Completion counts, missing-data handling, and the analysis population are not reported in the registry record. That information would be needed to judge how fully the endpoint summaries represent the enrolled group.

The adverse-event counts are also descriptive and come from a single group. They do not provide a comparative safety estimate. In short, the record identifies a relevant exploratory question and a defined way to ask it, but it does not report the numerical primary findings needed to characterize participants’ ratings. Neither efficacy nor lack of efficacy can be concluded from the absence of endpoint results.

13. Why This Trial Matters Statistically

This study raises a statistical question that differs from the usual treatment-versus-control comparison. Its stated aim is to identify possible adaptations of CALM for people with cancer metastasis to the brain, and its primary endpoint asks participants whether the intervention’s domains apply to their experience. That makes clear definition of the population, scale, timing, and domain-specific results important to understanding the intended evidence.

The endpoint has several components: four domains, an ordered rating scale, and a mean and standard deviation as planned summaries. Statistical reporting would be most informative if readers could understand both the average ratings and their variation, as well as how the individual domains were handled. The registry record identifies the domains and scale but does not report the observed ratings or a scoring rule for a combined result.

The design also illustrates why the research question and the estimand need to match. A single-group applicability assessment can describe participants’ views, but it does not offer a controlled estimate of how those views compare with an alternative. A descriptive endpoint may be appropriate to an adaptation-focused objective, while still being unable to establish a causal effect. These are different kinds of evidence, not interchangeable conclusions.

Finally, the distinction between enrollment and analysis is consequential. Although 13 participants were enrolled, the registry does not report the number contributing to the primary endpoint or the handling of missing responses. Those details, along with the actual domain ratings, would be needed to assess the representativeness and precision of the findings. Since numerical endpoint results are not reported, the study’s statistical contribution cannot be evaluated beyond its design and measurement plan.

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 principal limitation for interpreting this registry record is that the primary endpoint is defined but its numerical results are not reported. The mean, standard deviation, domain-specific values, and uncertainty estimates are unavailable, so the extent and variability of perceived applicability cannot be assessed.

The study is single-group and has no control arm. It cannot provide a like-for-like comparison or isolate an intervention effect. The registry does not report a baseline assessment for the primary endpoint, so change in applicability ratings cannot be evaluated either.

The enrolled total is 13, but the number of participants who completed the exit interview or contributed endpoint data is not reported in the registry record. Participant characteristics, recruitment details, eligibility criteria, and representation across the named populations are also not reported. This limits assessment of how broadly any findings would apply, even if endpoint results were available.

The registry record does not describe the statistical analysis plan, missing-data methods, analysis population, scoring rule for combining domains, or procedures for handling multiple outcomes. The planned mean and standard deviation are named, but the record does not clarify whether the primary result was to be domain-specific, combined, or both. Such details would affect the interpretation of the endpoint.

The intervention is described as telehealth CALM, with surveys at several stages and a phone exit interview, but the number and content of sessions, intervention adherence, and fidelity procedures are not reported in the registry record. Qualitative exit-interview findings and any adaptation decisions are also not reported. These limitations constrain interpretation of both implementation and the study’s adaptation-focused objective.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Managing Distress in Malignant Brain Cancer — NCT05087095.
• Registry record last updated 2025-04-09; status last verified 2025-03.
• Results first posted 2025-04-09.
• 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 record describes a completed, single-group behavioral study of the CALM intervention, sponsored by Virginia Commonwealth University, with 13 participants enrolled. It lists the study start as 2022-03-23, primary completion as 2023-11-01, and status as completed.

The primary endpoint was intended to assess the applicability of four CALM domains through participant ratings at an exit interview. Ratings use a scale from 1 (not applicable) to 5 (very applicable), with higher scores meaning greater applicability; the planned summaries are a mean and standard deviation. The intervention was delivered by telehealth, with surveys and phone exit interviews described in the record.

There was no comparator. The record lists six outcome measures and zero analyses. Numerical results for the primary endpoint, endpoint completion counts, missing-data methods, and the statistical analysis plan are not reported in the registry record. The adverse-event entries list 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths, with 13 at risk in each adverse-event category.