This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Managing Cancer and Living Meaningfully (NCT04646213), a na na study. The primary outcome is Recruitment for CALM.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04646213 |
| Phase | NA |
| Condition | Mood, Cancer Brain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 14 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Virginia Commonwealth University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with primary brain tumors are the intended population, based on the official trial title and summary. The registry lists Mood and Cancer Brain as conditions. It does not report further eligibility details or describe the enrolled participants in enough detail to assess how broadly the findings might apply.
Intervention
The intervention is Managing Cancer and Living Meaningfully (CALM) Therapy, described as a psychotherapeutic intervention. The study is characterized as a pilot test intended to better understand potential effects on mood and quality of life. Specific details about how therapy was delivered, its duration, or the amount of contact with participants are not reported in the registry record.
Comparator
There is no separate comparator group in this single-group study. The registry does not describe a randomized comparison, and allocation is listed as NA. The therapy group therefore cannot be compared with a concurrent control group using the registered design.
Primary question
The primary endpoint is Recruitment for CALM, defined as the number of potential participants consented and enrolled, with a timeframe of 1 day. This is a recruitment measure, not a direct measure of mood, quality of life, or treatment effect. The record lists enrollment of 14, but does not report a separate analyzed result for the primary endpoint or explain the recruitment denominator.
3. Trial Design
The registry describes Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients as a completed, single-group study. Its stated purpose is to pilot test CALM, an empirically supported psychotherapeutic intervention, and better understand its potential benefits for mood and quality of life. The registry identifies the intervention as behavioral and lists one therapy group. It does not identify a control group or a randomized allocation process.
The record lists enrollment of 14 and names Virginia Commonwealth University as the sponsor. The study start is recorded as 2020-12-03, and primary completion as 2021-09-14. Its status is completed. Phase is listed as NA. Masking is listed as none. Further information about recruitment procedures, eligibility criteria, intervention delivery, follow-up, or the characteristics of participants is not reported in the registry record.
The primary outcome is titled Recruitment for CALM. It measures the number of potential participants consented and enrolled, over a stated timeframe of 1 day. The record also lists 10 outcome measures, but does not report their analyzed results. It records 0 analyses. Consequently, the design and registry metadata describe the study’s structure and intended questions, but do not provide a reported statistical evaluation of mood, quality of life, or other outcomes.
A single-group pilot can describe whether participants were recruited and can collect information useful for planning or refining future research. It cannot, by itself, separate changes after an intervention from changes that might have occurred over time or for other reasons. The registry does not report a concurrent comparison that would address that limitation. Nor does the record state a sample-size justification, a planned analytic approach, or whether the study was designed to test a treatment effect.
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
| Stage | Therapy |
|---|---|
| STARTED | 14 |
| COMPLETED | 9 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Therapy |
|---|---|
| Physician Decision | 3 |
| Withdrawal by Subject | 2 |
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.
| Characteristic | Unit | Therapy |
|---|---|---|
| Participants analysed | 14 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 |
| Age, Categorical: >=65 years | Participants | 5 |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 13 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 14 |
6. Primary Endpoint
The registry lists the primary outcome as Recruitment for CALM, measured over 1 day.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint, Recruitment for CALM, is defined as the number of potential participants consented and enrolled. Its unit is participants, and its timeframe is 1 day. This endpoint concerns recruitment activity: it records whether potential participants entered the study, rather than measuring mood, quality of life, tumor status, or a response to therapy. The registry lists enrollment of 14, but does not separately report the analyzed value for this endpoint, its denominator, or how the stated timeframe was applied.
As a general statistical consideration, recruitment measures are useful in pilot research because they can help describe whether a study is feasible to conduct. A clearly defined recruitment count can inform planning about recruitment processes, but its interpretation depends on context, such as the number of people approached or eligible and the period over which recruitment occurred. Those details are not reported in the registry record, so the listed enrollment alone cannot establish a recruitment rate or indicate how recruitment compared with a target.
This endpoint also does not answer the study’s broader question about potential effects on mood or quality of life. Those concepts may be addressed by other listed outcomes, but their results and measurement details are not reported in the registry record. Recruitment should therefore be interpreted as a study-process measure, not as evidence about clinical benefit or the magnitude of any change in participants’ wellbeing.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that this was a completed pilot study of CALM therapy in a single group, with enrollment of 14. Its primary endpoint concerns recruitment: the number of potential participants consented and enrolled, with a timeframe of 1 day. The record does not report a separate analyzed result for that endpoint. It also lists 10 outcome measures but records 0 analyses. Thus, the registry information does not provide an inferential result about mood, quality of life, or another measured outcome.
There is no concurrent comparator group. This matters because a change observed within a treated group, if such a change were reported, would not by itself show that therapy caused the change. General explanations include natural change over time, other care, measurement variation, and factors related to which participants enrolled. A controlled comparison can help address some of these alternative explanations, but the registry does not describe one for this study.
The primary endpoint is also distinct from a measure of treatment effect. A count of consented and enrolled participants can describe recruitment, but without a reported denominator or recruitment target it cannot be interpreted as a rate or as evidence that recruitment met a particular standard. The registry’s enrollment figure is a study-level record, not a reported analysis of the primary endpoint within its stated timeframe.
The adverse-event entry lists zero participants at risk and zero affected for both serious and other events in the therapy group. These entries do not establish that no adverse events occurred. With zero recorded as at risk, the record does not provide an interpretable event rate or a clear basis for assessing safety. The registry also does not report the details needed to clarify how adverse events were collected or classified.
Accordingly, the posted record supports a description of the study design, recruitment endpoint, enrollment, and selected registry fields. It does not support a conclusion about the size, precision, or cause of changes in mood or quality of life. A confidence interval, when reported for an estimate, describes the uncertainty associated with that estimate under the analysis assumptions; no such result for the primary endpoint or the listed clinical outcomes is reported in the registry record.
The record includes planning assumptions for illustrative sample-size calculations: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of an observed effect. Those assumptions describe hypothetical planning calculations, not the study’s single-group design. They are not evidence of observed power, and the registry does not report the trial’s own sample-size justification or statistical plan.
9. Statistical Methods Explained
What does the design allow?
As a general statistical principle, a single-group design describes observations in the group receiving the intervention. It does not provide a concurrent estimate of what would have happened to comparable participants without the intervention. Without that comparison, an observed change cannot be attributed to therapy alone. The registry identifies this study as single-group and does not describe a randomized comparison. Its results, if reported, would need to be interpreted as descriptive or exploratory unless a suitable analysis and design supported a stronger claim.
The registry lists allocation as NA and masking as none. These are design descriptors; they do not, by themselves, establish how participants were selected, what they knew about the study, or how outcomes were assessed. Those details are not reported in the registry record. Likewise, the phase is listed as NA, which does not supply information about the study’s analytic objectives or the strength of evidence it can provide.
What does the recruitment endpoint measure?
The primary endpoint is a count of potential participants consented and enrolled, measured in participants over 1 day. Counts are generally interpreted by considering what event is counted, the population from which it is counted, and the period of observation. Here, the endpoint description identifies the event and the stated timeframe, but the record does not report a recruitment denominator, a target, or a separate analyzed result. Enrollment of 14 is recorded, but it should not be substituted for a recruitment rate or treated as a distinct endpoint analysis.
In general, a recruitment count can be useful for describing the conduct of a pilot. To assess recruitment efficiency or feasibility more fully, researchers would usually need contextual information about the people approached, their eligibility, and the recruitment process. The registry record does not report those details. No rate or other recruitment summary can be inferred without them.
How should outcome estimates and uncertainty be read?
In general, an estimate summarizes the observed data under a defined analysis. A confidence interval expresses uncertainty around an estimate under the assumptions of the method used; it is not a guarantee that the true value lies within the interval, nor does it account automatically for bias or design limitations. No estimates or confidence intervals for the primary endpoint or clinical outcomes are reported in the registry record, so their magnitude and precision cannot be assessed from the recorded results.
Counts of participants with an event are one possible outcome form. For such data, interpretation depends on the number of participants observed, the time period, and the event definition. If observations vary more than a simple probability model allows, over-dispersion can make standard errors too small and intervals too narrow unless the analysis accounts for it. This is a general consideration only; the registry does not report an event-outcome analysis or an over-dispersion assessment for this study.
The adverse-event fields list zero at risk and zero affected in the therapy group for serious and other events. A zero count cannot be interpreted in isolation when the number at risk is also recorded as zero. It does not provide an event rate or demonstrate the absence of events. Details of event ascertainment and the analysis population are not reported in the registry record.
What do the planning assumptions mean?
The record describes planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are stated as assumptions for hypothetical sample-size planning, not as the design of this single-group trial. The record also says that the effect to detect is a stated fraction of the observed effect; those planning illustrations are not observed power. The registry does not report the trial’s own sample-size justification, any prespecified effect, or a statistical analysis plan. No additional sample-size conclusion should be inferred from those assumptions.
In general, a planning calculation estimates how much information a future study might need under chosen assumptions. Its result depends on the effect size, outcome variability, significance level, allocation, and analysis method. If assumptions are uncertain or do not match the future design, the calculation may not transfer. For this study, the two-arm equal-allocation assumptions do not describe the recorded single-group structure, so they should be understood only as hypothetical planning assumptions, not as a description of how participants were assigned.
What can be concluded from the recorded analyses?
The registry records 0 analyses, and no analysis method is reported. This means the record does not provide a basis for evaluating adjustment, uncertainty estimation, handling of repeated measurements, or comparisons among outcomes. It would be inappropriate to assign a statistical test or model to the study based on the design description alone. Any such methods would need to be documented in the registry record or an analysis report before their assumptions and results could be assessed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and records 0 analyses. It does not report which outcomes were analyzed, which were designated primary beyond the recruitment endpoint, or whether any multiplicity procedure was planned or used. The status of outcome-specific hypotheses and analysis populations is not reported in the registry record.
As a general statistical consideration, examining multiple outcomes can increase the chance of finding an apparently notable result by chance, especially if many tests are treated as independent opportunities for a positive finding. A prespecified outcome hierarchy or an adjustment for multiple comparisons can help control that issue, but no such approach is reported. Without outcome results or analysis details, the extent to which multiplicity affects interpretation cannot be assessed.
Missing-data methods, the amount of missing information, and reasons for missingness are not reported in the registry record. In general, missingness can affect both the estimate and its uncertainty, particularly when the likelihood of missing data is related to participants’ outcomes or study experience. An analysis that excludes participants with incomplete observations may differ from one that uses another explicit method; which approach is appropriate depends on the data and assumptions. No approach can be attributed to this study from the registry information.
The record does not define an intention-to-treat, per-protocol, or other analysis population. Such populations specify which participants contribute to a particular analysis and can affect interpretation. Enrollment of 14 does not establish how many participants contributed to any outcome analysis, especially since no analyses are recorded. The available information therefore does not support conclusions about attrition, completeness, or the handling of participants after enrollment.
11. What the Result Does, and Does Not, Mean
The registry record describes a completed pilot of CALM therapy in primary brain tumor patients, with a single therapy group and enrollment of 14. Its primary endpoint is recruitment: the number of potential participants consented and enrolled over a stated timeframe of 1 day. The record does not report a separate analyzed result for that endpoint. It lists 10 outcome measures and records 0 analyses, so it does not provide reported statistical findings about mood, quality of life, or other clinical outcomes.
This information does not show that the intervention improved or worsened participants’ wellbeing. It also does not establish that there was no effect. The absence of reported analysis results is not equivalent to a finding of no difference or no change. Because there is no concurrent control group, a within-group change, if reported elsewhere, would not by itself establish that therapy caused it.
The enrollment entry should not be read as a recruitment rate or as proof that a recruitment goal was met. The registry does not report the number of people approached or eligible, a target, or the endpoint’s analyzed value. Similarly, the adverse-event fields, which list zero at risk and zero affected, do not demonstrate that no events occurred or establish safety.
The record can therefore support a limited account of the study’s design and registered aims, but not a judgment about treatment effect, precision, or comparative safety. General statistical interpretation requires the underlying outcome data, defined analysis populations, methods, and uncertainty estimates. Those results and details are not reported in the registry record.
12. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a pilot’s feasibility questions and a test of clinical effect. Its primary endpoint concerns recruitment, while the study’s stated motivation includes potential effects on mood and quality of life. Those are different kinds of questions and require different outcome information. A recruitment count can describe study conduct; it cannot establish a change in a participant’s clinical state.
The single-group design is another important feature. In general, observations from one group can describe what happened among participants, but they do not supply a concurrent counterfactual comparison. That limits causal interpretation, even if clinical outcomes are eventually reported. A future controlled study could address a different question by comparing outcomes between groups, subject to its design and analysis assumptions.
The registry record also highlights why outcome definitions and analysis reporting matter. It names 10 outcome measures but records 0 analyses. Without outcome-specific estimates, uncertainty measures, missing-data information, or analysis populations, readers cannot assess the magnitude or precision of any clinical findings. Reporting the recruitment denominator and the endpoint result would also make the feasibility question more interpretable.
Finally, hypothetical sample-size planning assumptions should not be confused with the study’s design or evidence. The record describes two-arm equal-allocation assumptions, whereas the trial is listed as single-group. Such planning illustrations are not observed power and do not replace a documented sample-size rationale. Taken together, the registry information makes design transparency and complete results reporting central to evaluating what this pilot can contribute.
13. 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 trial-specific limitation is the single-group design. There is no concurrent control group in the registry record, so the study cannot provide a like-for-like comparison of outcomes with and without CALM. This constrains causal interpretation of any changes that might be reported. The record also lists no masking, and does not report details about outcome assessment that would clarify how potential measurement bias was addressed.
The primary endpoint is a recruitment count with a timeframe of 1 day, but the registry does not report a separate analyzed value, denominator, or recruitment target. Although enrollment is listed as 14, that entry does not show how many people were approached, eligible, or consented during the endpoint timeframe. It therefore cannot establish recruitment efficiency or whether a feasibility benchmark was achieved.
Clinical outcome interpretation is limited by the absence of reported analyses. The registry lists 10 outcome measures, but gives no analyzed estimates, uncertainty intervals, or methods. It also does not report missing-data handling, the analysis population, intervention delivery details, or participant characteristics sufficient to judge applicability. The adverse-event entry lists zero at risk and zero affected, which does not permit estimation of event frequency.
The registry does not report a sample-size justification or statistical analysis plan. Its stated planning assumptions describe hypothetical two-arm calculations, which do not match the listed single-group design. These limitations concern what can be learned from the registry record; they do not establish what analyses or results may exist outside it.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Managing Cancer and Living Meaningfully — NCT04646213.
- Registry record last updated 2024-03-13; status last verified 2024-03.
- Results first posted 2024-03-13.
- 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.
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17. Record Summary
NCT04646213 is a completed, single-group pilot of Managing Cancer and Living Meaningfully (CALM) Therapy in primary brain tumor patients. Virginia Commonwealth University is listed as sponsor. The registry records enrollment of 14, a start date of 2020-12-03, and primary completion on 2021-09-14. Phase is listed as NA, allocation as NA, and masking as none.
The primary endpoint, Recruitment for CALM, is defined as the number of potential participants consented and enrolled, with a timeframe of 1 day. The record lists 10 outcome measures and 0 analyses. It does not report an analyzed primary-endpoint result, clinical outcome estimates, or a statistical analysis plan. The adverse-event fields list zero at risk and zero affected in the therapy group, which does not establish event rates. Overall, the registry record describes the study structure and aims but does not report statistical results that quantify effects on mood or quality of life.