Enhancing Community Capacity to Improve Cancer Care Delivery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Enhancing Community Capacity to Improve Cancer Care Delivery (NCT04107116), a non-randomized na study. The primary outcome is Edmonton Symptom Assessment Scale (ESAS) Symptom Screen.

2. Clinical Question

3. Trial Design

The registry describes a parallel-group, nonrandomized study of a behavioral intervention and usual care. The intervention group was assigned a lay health worker, while the control group received usual care from local oncologists. The stated intervention includes proactive symptom assessments for up to 12-months and an expansion intended to support referrals to palliative care and behavioral health. The record lists 832 participants as the enrollment.

There is an important qualification to the allocation description. The registry classifies allocation as nonrandomized, but the intervention-arm description refers to patients being randomized into the intervention. These statements conflict. The classification and the accompanying warning indicate that this is not a randomized comparison and that the arms should not be interpreted as like-for-like controls. The exact allocation process is not reported in the registry record.

The study is labeled parallel and triple masked. The registry does not explain who was masked, what information was concealed, or how masking was maintained. It also does not describe the allocation mechanism or provide enough detail to evaluate how differences between groups were handled in analysis.

The study is listed as completed. Its recorded start was 2016-11-01, and primary completion was 2020-09-30. The registry lists cancer and end of life among the conditions. Those labels describe the registry record; they do not by themselves establish that all participants were at the end of life.

The registry lists 15 outcome measures, including symptom assessment, healthcare use, hospice consultation, costs, and end-of-life care measures. It reports zero analyses. Comparative estimates, uncertainty intervals, and statistical test results are not reported in the registry record. As a result, the design and planned outcomes can be described, but the effects observed in the groups cannot be assessed from the reported information.

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: One oncology clinic was excluded due to involvement in a previously reported intervention in the sources. The study also excluded clinic patients that did not receive medical oncology care.

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.

Population: Amongst the 832 participants, 6 baseline characteristics were measured between the intervention and control arms.

6. Primary Endpoint

The registry lists the primary outcome as Edmonton Symptom Assessment Scale (ESAS) Symptom Screen, measured over Baseline (at time of patient enrollment).

The primary endpoint is the total score on the Edmonton Symptom Assessment Scale (ESAS) at baseline, defined as the time of patient enrollment. The scale assesses the intensity of 10 symptoms. Each symptom is rated on an 11-point scale from 0 to 10, and the symptom subscores are combined into a total score ranging from 0 to 10. Higher values correspond to worse symptom severity.

As a general measurement concept, a combined symptom score can describe overall reported symptom burden in a compact form. It may be useful for characterizing patients’ symptoms at study entry and for comparing baseline profiles between groups. The score does not, by itself, identify which individual symptoms account for a total value; the component ratings would be needed for that more specific interpretation.

The timing matters: this is a baseline assessment, not a reported change from baseline or a later treatment response. A baseline group difference would describe the groups at enrollment, not an effect caused by the intervention. The registry record does not report the baseline group means, ranges, or a between-group estimate, so the degree of similarity or difference at enrollment cannot be evaluated.

The record specifies a mean and full-range summary for this outcome. It does not report observed summary values. The scale’s definition therefore explains what the endpoint is intended to measure, but it does not provide evidence about the symptom burden observed in either group.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry labels the study as parallel, nonrandomized, and triple masked. These labels answer different design questions. A parallel design means participants are assigned to one of the study groups rather than moving through both groups in sequence. Nonrandomized allocation means that assignment was not classified as random in the registry. Triple masking indicates a masking label, but the identities of the masked parties and the procedures used are not reported in the registry record.

The intervention group received a lay health worker, with proactive symptom assessments described for up to 12-months. The control group received usual care from local oncologists. The registry’s intervention-arm description includes wording that patients were randomized, while the allocation classification is nonrandomized. Because those statements conflict, the precise allocation process cannot be inferred. The registry warning also states that the arms are not a like-for-like control comparison. Any comparison should therefore be interpreted with the possibility of baseline differences and confounding in mind.

What the primary measure represents

The primary endpoint is the ESAS total score at enrollment. It combines ratings for 10 symptoms, each rated on a scale from 0 to 10, into a total symptom score that also ranges from 0 to 10. The record identifies the outcome as a mean with a full-range summary. A mean describes the average score, while the full range describes the lowest and highest observed values. These are descriptive summaries; without reported group values, they cannot establish whether groups were similar or different.

As a general statistical concept, a confidence interval describes a range of values compatible with the data and the method used to estimate uncertainty. Its width reflects precision: broader intervals indicate less precise estimates, while narrower intervals indicate greater precision. No confidence interval is reported for the primary outcome in the registry record, so the precision of a group contrast is unknown. A p-value, also not reported, would address compatibility with a specified null hypothesis under the chosen model; it would not communicate the size or practical importance of an effect on its own.

Why allocation affects comparisons

In nonrandomized studies, baseline characteristics can differ because of how people enter or are assigned to groups. This can distort an unadjusted comparison if those characteristics are also associated with the outcome. General methods for addressing measured confounding include regression adjustment, stratification, or weighting, but each depends on assumptions and on having appropriate information about relevant covariates. The registry record does not report which methods, if any, were used. It also does not report the covariates collected or the analysis population.

Masking can reduce some forms of bias in outcome assessment or care, depending on who is masked and what processes are involved. A masking label alone is not enough to determine whether assessments were blinded or whether participants and clinicians knew group assignment. Those details are not reported in the registry record.

Planning calculations and observed results

The sample-size assumptions describe planning illustrations based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The record also distinguishes the reporting convention for time-to-event planning from other outcomes. These assumptions describe illustrations, not the trial’s own design justification. The registry does not report a sample-size justification for the trial itself. No planning illustration is an observed result, and a planned sample size cannot substitute for an effect estimate or its uncertainty.

The record lists 15 outcome measures and zero analyses. It does not report a statistical analysis plan, model specification, covariate adjustment, handling of repeated symptom assessments, or details of how outcomes were summarized. Those omissions prevent an assessment of whether the analysis matched the intended estimand, which is the specific treatment contrast and outcome the analysis is meant to estimate.

As a general concept, over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can make model-based uncertainty too small if not handled appropriately. Whether over-dispersion is relevant depends on the particular outcome and model; the registry does not report models or diagnostics from which to assess it. Likewise, a count outcome, binary outcome, cost outcome, and symptom score may require different modeling choices. The record lists several kinds of outcomes but does not report the methods used for them.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 15 outcome measures, including the baseline ESAS symptom score and outcomes concerning emergency department visits, hospitalization, hospice consultation, costs, and end-of-life care. It reports zero analyses. The registry record does not report how many outcomes were designated primary for analysis beyond the listed primary outcome, whether secondary outcomes were tested, or how multiple statistical tests were handled.

As a general statistical concept, testing many outcomes can increase the chance that at least one result appears noteworthy by chance. A multiplicity plan may control that risk by defining a hierarchy, adjusting significance thresholds, or treating some analyses as exploratory. The plan used in this study is not reported in the registry record, so the interpretation of any potential collection of tests cannot be assessed.

Missing-data procedures are also not reported in the registry record. The record does not state how incomplete symptom questionnaires, unavailable claims, or missing chart-review information were handled. As a general matter, conclusions can depend on why data are missing and whether missingness differs across groups. Complete-case analysis, imputation, and other approaches rely on assumptions; without a reported method and information about missingness, the impact on estimates cannot be evaluated.

The analysis populations are not reported in the registry record. It is therefore unclear which participants would have been included in each outcome analysis, how departures from the intervention were treated, or whether denominators varied by outcome. The posted enrollment alone does not establish the number contributing data to any particular analysis.

Interim analyses and stopping rules are not reported in the registry record. Nor is a statistical analysis plan reported. These are distinct from the trial’s outcome definitions and should not be inferred from the registry’s design labels or planning assumptions.

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 serious adverse events for the intervention and control groups. For the intervention group, 425 participants are listed as at risk, with 0 affected by serious adverse events; for the control group, 407 are listed as at risk, with 0 affected. The counts for other adverse events are also listed as 0 in each group, with 425 and 407 at risk, respectively.

The record separately lists deaths: 180 in the intervention group and 189 in the control group. These figures should not be treated as counts of deaths caused by the intervention. The registry does not report attribution, timing details, or a safety comparison that would explain how the death counts relate to the adverse-event entries.

As a general principle, zero recorded events in a registry field does not prove that no events occurred in the wider population or that the intervention is free of risk. Interpretation depends on the event definitions, follow-up completeness, ascertainment methods, and reporting scope. Those details are not reported in the registry record. The safety entries should therefore be read as recorded counts, not as a comprehensive comparative safety assessment.

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

The registry record identifies a study of a lay health worker intervention intended to expand symptom assessment and support referrals for people with cancer. It describes usual care as the comparator and names baseline ESAS symptom burden as the primary outcome. It also lists outcomes involving healthcare use, hospice consultation, costs, and end-of-life care. These elements show the scope of the evaluation, not its findings.

The record does not report comparative estimates for the primary or secondary outcomes. It therefore does not show the size or direction of any difference between the groups, nor the precision of such a difference. Without outcome estimates and uncertainty intervals, readers cannot determine whether observed effects, if any, were small or large, or whether estimates were precise or uncertain. The absence of reported analyses should not be interpreted as a finding of no effect.

The nonrandomized classification is central to interpretation. Groups in a nonrandomized study may differ for reasons other than the intervention. The registry warning explicitly notes that the arms are not a like-for-like control comparison. Even if group outcome values were available, a causal interpretation would require attention to confounding, group comparability, and the methods used to adjust for differences. Those analysis details are not reported in the registry record.

The baseline primary measure also has a limited role: it characterizes symptoms at enrollment, rather than demonstrating change after the intervention. The description of symptom assessment for up to 12-months does not supply follow-up results. Similarly, the safety counts should not be used to infer causation or to conclude that no safety concerns occurred.

In short, the record supports a description of the study design, intervention, comparator, outcome definitions, and selected safety counts. It does not support a conclusion about intervention effectiveness, the magnitude of any outcome difference, or the certainty of an effect.

13. Why This Trial Matters Statistically

This study raises several statistical issues that matter for interpreting evaluations of care-delivery interventions. First, the registry classifies allocation as nonrandomized and warns that the two arms are not a like-for-like comparison. That makes the distinction between an observed group difference and an intervention effect especially important. The groups may differ for reasons that also influence symptoms, healthcare use, or costs.

Second, the primary outcome is a baseline symptom score. Baseline measurement can describe the participants’ symptom burden at enrollment and can help characterize group comparability. It does not, by itself, measure improvement or a response to the intervention. A clear separation between baseline description and follow-up effect is essential when reading outcome labels and study summaries.

Third, the listed outcomes span different types of information: a symptom scale, healthcare-use events, hospice consultation, costs, and end-of-life care. General statistical practice recognizes that different outcome types may call for different models and assumptions. The registry record does not report the models or analyses used, so readers cannot examine those choices or their influence on estimates.

Fourth, the intervention involves contact and assessment by lay health workers, while the comparator is usual care from local oncologists. This is a delivery-of-care comparison, not just a comparison of two measurement techniques. Interpretation would require attention to implementation, participant exposure, and outcome ascertainment; details beyond the intervention description are not reported in the registry record.

Finally, the record lists 15 outcomes but zero analyses. Without reported estimates, uncertainty, missing-data methods, and multiplicity handling, statistical significance and clinical relevance cannot be assessed. The example underscores why outcome definitions and study labels are not substitutes for transparent reporting of analyzed 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 main limitation for interpreting this study is the absence of reported comparative outcome estimates. The registry lists 15 outcome measures but zero analyses, and does not provide group results for the primary ESAS endpoint or the other listed outcomes. Effect size, uncertainty, and the direction of any differences cannot be assessed from the registry record.

The allocation description is also internally inconsistent: the registry classifies the study as nonrandomized, while the intervention-arm description refers to patients being randomized. The record’s warning says the arms are not a like-for-like control comparison. The allocation process and the reasons for group assignment are not reported in the registry record, limiting assessment of comparability and potential confounding.

The primary outcome is specified at baseline, at enrollment. Although proactive symptom assessments are described for up to 12-months, follow-up symptom results are not reported. The registry record therefore does not establish whether the primary measure was analyzed as a baseline characteristic, whether later symptom scores were evaluated, or how repeated measurements were handled.

Key analytic details are absent. The statistical analysis plan, covariates, analysis populations, missing-data approach, multiplicity procedure, and interim-analysis plans are not reported in the registry record. The masking label is triple, but the people masked and the procedures are not described. These gaps prevent a detailed assessment of bias, precision, and robustness.

Safety interpretation is limited as well. The record reports zero serious and other adverse events in each group and lists deaths, but does not report attribution, timing details, or the methods used to ascertain events. The counts alone cannot establish comparative safety or cause.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Enhancing Community Capacity to Improve Cancer Care Delivery — NCT04107116.
• Registry record last updated 2025-02-27; status last verified 2025-02.
• Results first posted 2025-02-27.
• 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 NCT04107116, titled Enhancing Community Capacity to Improve Cancer Care Delivery. It lists a parallel, nonrandomized study with triple masking and enrollment of 832. The intervention assigns a lay health worker for proactive symptom assessments for up to 12-months, while the control group receives usual care from local oncologists.

The primary outcome is the baseline ESAS total symptom score, ranging from 0 to 10, with higher values corresponding to worse symptom severity. The record lists 15 outcome measures and reports zero analyses. It does not report comparative outcome estimates, confidence intervals, p-values, or a statistical analysis plan.

The registry lists zero serious adverse events and zero other adverse events in both groups, and records deaths of 180 in the intervention group and 189 in the control group. The allocation classification conflicts with wording in the intervention-arm description, and the record warns that the arms are not a like-for-like control comparison. The study is listed as completed, with primary completion on 2020-09-30.