National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC (NCT03982459), a na na study. The primary outcome is Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations.

2. Clinical Question

The central question concerns how participants engaged with care recommendations after using the decision-support tool, rather than a comparison of outcomes between randomized treatment groups. The selected benchmarks cover smoking-cessation counseling, adjuvant chemotherapy after surgery for specified stages, mediastinal staging before surgical or nonsurgical management, definitive chemoradiotherapy for specified stage III disease, and molecular testing for specified stage IV disease. Each benchmark applies to a particular clinical circumstance, so the number of participants eligible to evaluate a benchmark may differ from the overall enrollment.

The registry also lists secondary measures involving decisional conflict, satisfaction with health-care decisions, decision-support preference, quality of life, lung symptoms, and reported agreement with a physician after consultation. These topics describe the broader evaluation of the tool, but their results are not reported in the registry record. The record therefore identifies what investigators intended to assess without establishing what participants reported on those measures.

3. Trial Design

This was a completed, single-group study of a behavioral decision-support tool for people with non-small cell lung cancer. The sponsor was the University of California, San Francisco. The registry lists enrollment as 76, the phase as NA, allocation as NA, and masking as none. The recorded study start was 2015-02-01 and primary completion was 2017-09-01.

Participants received training in use of the decision-support tool from a trained coordinator. The tool was based on the patient version of the NCCN guidelines and presented individually tailored decision trees. The primary outcome description says participants explored those trees and that investigators assessed whether participants demonstrated quality of care on selected guideline-derived benchmarks.

The design does not establish a randomized comparison of the tool against a control intervention. The registry explicitly identifies the study as not being a randomized comparison and cautions that arms are not a like-for-like control comparison. Consequently, the record supports describing an evaluation within a single-group setting, not a causal contrast between independent trial groups. The absence of masking is also recorded, but the registry does not report further details about how outcome assessment was conducted.

The registry lists seven outcome measures and zero analyses. It records several secondary outcome topics, but does not include their numerical findings. The primary outcome has a timeframe of 1 Day and a description of the benchmarks and eligibility tailoring, but its percentage results are not reported in the registry record. Protocol details such as the planned statistical analysis, sample-size justification, and interim analyses are not reported in the registry record. The design should therefore be interpreted from the information actually recorded: a completed single-group assessment, with tool training and guideline-based measures, but without posted analysis results that permit evaluation of the primary outcome.

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

Analysis population for the primary outcome, as defined in the registry: Nine participants were missing survey results preventing calculation for this measure

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 Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations, measured over 1 Day.

The primary endpoint is the percentage of participants reporting quality of care on selected NCCN recommendations. The outcome description focuses on whether participants who interacted with a tailored decision tree demonstrated care consistent with a relevant guideline-derived benchmark. Its timeframe is 1 Day.

The six benchmarks address documented smoking-cessation counseling in active smokers; adjuvant chemotherapy after surgery for patients with stage IB to IIB NSCLC; pathologic mediastinal staging before surgery or nonsurgical management for patients with stage III NSCLC; definitive chemoradiotherapy for patients with stage III NSCLC not undergoing surgery; and molecular testing for EGFR and ALK alterations for patients with stage IV NSCLC. The two mediastinal-staging circumstances are listed as separate benchmarks.

This type of endpoint is used to describe how often a defined quality criterion is met among participants assessed for that criterion. Because the decision trees were tailored, not all participants evaluated all six benchmarks. The percentage for a benchmark therefore relates to participants who interacted with it, rather than necessarily to the full enrolled group. The registry notes that nine participants had missing survey results preventing calculation for this measure. It does not report the benchmark-specific denominators, percentages, or uncertainty estimates. Accordingly, the outcome definition is available, but the observed primary results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General: A percentage endpoint expresses the number of people meeting a defined criterion relative to the people assessed for that criterion. Interpreting it requires knowing both the numerator, meaning the number meeting the criterion, and the denominator, meaning the number assessed and eligible for that measure. In this study, the registry describes six guideline-derived benchmarks and says tailored decision trees meant not every participant evaluated all six. It does not report the benchmark-specific counts or denominators, so the percentages cannot be reconstructed from the registry record.

General: A confidence interval describes the range of estimates compatible with the observed data under a statistical method and its assumptions. It communicates uncertainty around an estimate; it is not a guarantee that the true value falls within that interval. No confidence intervals for the primary percentages are reported in the registry record. Without an estimate and its uncertainty, it is not possible to judge whether a benchmark-specific percentage is precise or imprecise.

General: A single-group study estimates outcomes within the group studied. A randomized comparison instead uses assigned groups to estimate a contrast under the trial design. Since this study is listed as single-group, with allocation NA, the primary question is descriptive in the posted record. The registry specifically cautions that this is not a randomized comparison and that arms are not a like-for-like control comparison. The listed design does not establish a causal treatment contrast.

General: Masking can affect how participants, staff, or assessors know which intervention is being delivered or evaluated. The registry records masking as none. It does not describe further safeguards for outcome assessment, so no additional masking procedures should be inferred.

General: Missing data matter when the participants with observed results differ in relevant ways from those without results. The registry says nine participants had missing survey results preventing calculation for the primary measure. It does not report why these surveys were missing, whether missingness differed across benchmarks, or what analysis approach was used. The record also does not report whether any imputation or sensitivity analysis was conducted. These omissions limit assessment of how missing information may affect the reported measure, especially because the measure’s results are not posted.

The registry lists seven outcome measures and zero analyses. It identifies secondary measures related to decisional conflict, satisfaction with health-care decisions, decision-support preference, quality of life, lung symptoms, and agreement with a physician. Those outcome descriptions do not specify the results or the statistical procedures used to analyze them. The statistical analysis plan is not reported in the registry record. In particular, it is not possible to determine from the record whether models adjusted for participant characteristics, how repeated measurements were handled, or how outcomes were summarized beyond the descriptions in their titles.

General: When a study assesses several outcomes or several related benchmarks, multiplicity can arise because multiple statistical questions are considered. Testing many outcomes can increase the chance of a chance finding if each test is treated independently at a conventional threshold. Researchers may prespecify a primary outcome, adjust for multiple testing, or frame secondary results as exploratory. The registry identifies a primary outcome and lists secondary outcomes, but its multiplicity strategy is not reported in the registry record. No inferential results are posted from which to assess the consequences of any testing strategy.

The sample-size assumptions described for planning illustrations specify 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. The same description says time-to-event illustrations use a total event count and other illustrations use participants per arm. These are planning assumptions, not the documented design of this single-group study. The registry record does not report the study’s own sample-size justification. It also does not report the primary observed effect needed to evaluate an illustration based on that effect. Such planning calculations should not be interpreted as observed power or as evidence of a trial finding.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary outcome and lists secondary measures, but it does not report a plan for handling multiplicity. It is therefore not reported in the registry record whether analyses across the six benchmarks or the secondary outcomes were adjusted for multiple comparisons, treated as descriptive, or interpreted under another prespecified approach. Because zero analyses are listed, there are no posted inferential results with which to assess any multiplicity procedure.

The primary outcome description states that tailored decision trees meant not every participant evaluated all six benchmarks. Each benchmark therefore has its own relevant assessment group, and the record does not provide benchmark-specific denominators or missingness details. It also states that nine participants had missing survey results preventing calculation for the primary measure. The reasons for the missing survey results, their distribution across benchmarks, and any method used to address them are not reported in the registry record.

The record lists 76 enrolled participants, but that total should not be assumed to be the denominator for every benchmark or secondary measure. The available description does not identify analysis populations for the outcomes, such as which participants were included in each calculation. Handling of incomplete secondary questionnaires and any exclusions from analysis are not reported in the registry record.

These gaps limit interpretation of both completeness and statistical uncertainty. They do not establish that a particular missing-data method or multiplicity adjustment was absent; they mean the registry record does not report whether one was used. The primary percentages and secondary outcome results are also not reported in the registry record, preventing assessment of how these issues affected actual estimates.

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 76 participants at risk in the Decision Support Tool group for the serious-adverse-event entry and records 0 participants affected. It also lists 76 at risk for other adverse events and records 0 affected. Deaths are recorded as 0. These are the figures in the registry’s safety entries; they describe what was recorded for the listed group.

A zero affected count means no participants were recorded as affected in that particular registry entry. It does not establish that every possible adverse event was systematically assessed or that no event occurred outside the reporting definitions or period. The registry lists no top serious adverse event terms. The specific follow-up period and detailed event-collection procedures are not reported in the registry record, so broader claims about safety surveillance cannot be made from these entries alone.

These counts should also be read in the context of the study design: a single-group evaluation of a behavioral decision-support tool, not a randomized comparison. They are not a comparative safety estimate against another group. The entries provide descriptive counts, not an estimate of a treatment-related difference.

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

The registry record establishes that the study evaluated a decision-support tool based on the patient version of NCCN guidelines for people with non-small cell lung cancer. Participants received training from a coordinator and explored individually tailored decision trees. The primary outcome was defined around participants’ reporting of quality of care on selected recommendations, with a timeframe of 1 Day.

What the record does not establish is the observed percentage meeting any benchmark. Benchmark-specific results, counts, denominators, and uncertainty estimates are not reported in the registry record. The primary outcome description and the fact that nine participants had missing survey results explain aspects of measurement, but they do not reveal the direction or size of an outcome.

The single-group design also limits what could be concluded even if descriptive percentages were available. The record does not describe a randomized control comparison, and it explicitly notes that the study is not a randomized comparison. A within-group observation would describe participants in the study, but would not alone show that the tool caused their responses or care-related reports.

The listed secondary outcomes indicate that investigators also considered decision conflict, satisfaction, preferences, quality of life, symptoms, and physician agreement. Their results are not reported in the registry record. The absence of these results means that the registry entry cannot support a quantitative account of participant experience across those measures.

Accordingly, the findings that can be stated from this record are about the study’s purpose, design, outcome definitions, enrollment, and recorded safety counts. The record does not permit conclusions about the size or precision of the primary outcome, comparisons across benchmarks, or causal effects. This is a limit of the information recorded, not evidence that the tool did or did not produce a particular outcome.

13. Why This Trial Matters Statistically

This study is statistically instructive because its primary endpoint is tailored to clinical context rather than applied uniformly to every participant. The registry describes six quality-of-care benchmarks, while also stating that not all participants evaluated all six. That makes benchmark-specific denominators central to interpretation. Reporting a percentage without clarifying who was assessed for that benchmark could obscure which population the estimate represents.

The record also illustrates the difference between an outcome definition and an outcome result. It gives detailed descriptions of guideline-based criteria and lists an outcome timeframe, but does not report the corresponding percentages. A clearly specified endpoint is necessary for interpreting a study, yet it cannot substitute for estimates and uncertainty measures. The registry’s listing of seven outcome measures and zero analyses makes the distinction particularly important.

The single-group design is another important statistical feature. It can describe observations among participants who used the tool, but it does not provide the randomized control contrast needed to separate the intervention’s contribution from other explanations. The record itself cautions against treating its arms as a like-for-like comparison.

Finally, the stated missing survey results highlight the need to understand outcome availability. The record identifies missingness that prevented calculation of the primary measure but does not report its causes, distribution, or handling. These design and reporting details shape the strength of any interpretation, independently of the clinical relevance of the guideline benchmarks.

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 outcomes is that the registry record does not report the primary percentages or the results of the listed secondary measures. It also lists zero analyses. Thus, it is not possible to assess the magnitude, direction, or precision of the measured outcomes from the registry record.

The primary measure applies to tailored decision trees, and not every participant evaluated every benchmark. Benchmark-specific denominators and counts are not reported, so the populations represented by any potential percentage cannot be examined. The record notes nine participants with missing survey results that prevented calculation for this measure, but does not describe the reasons, distribution, or handling of the missing information.

The study is single-group and not a randomized comparison. The record states that arms are not a like-for-like control comparison. This limits causal interpretation and means that no comparative effect of the tool can be established from the described design. Masking is listed as none, while further details about outcome assessment are not reported in the registry record.

The statistical analysis plan, sample-size justification, interim analyses, and multiplicity approach are not reported in the registry record. The planning assumptions described for sample-size illustrations refer to equal allocation between two arms, which is not the recorded single-group design. Such illustrations are planning scenarios, not observed power, and the primary observed effect needed to evaluate an effect-based illustration is not reported in the registry record.

These limitations concern what can be learned from the registry entry. They do not indicate that unreported procedures were or were not performed; they indicate that those details are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC — NCT03982459.
• Registry record last updated 2025-01-09; status last verified 2024-10.
• Results first posted 2025-01-09.
• 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

NCT03982459 is a completed, single-group study sponsored by the University of California, San Francisco. It evaluated a behavioral decision-support tool based on the patient version of NCCN guidelines for non-small cell lung cancer. The registry lists enrollment of 76, no masking, and a primary completion date of 2017-09-01.

The primary outcome concerns the percentage of participants reporting quality of care on selected recommendations. Six benchmarks are described, with tailored decision trees meaning that not all participants evaluated every benchmark. The record notes nine participants had missing survey results preventing calculation for the primary measure, but does not report the benchmark-specific results. Seven outcome measures and zero analyses are listed.

The safety entries record 0 serious adverse events, 0 other adverse events, and 0 deaths among the listed group. The study is not a randomized comparison. Primary and secondary outcome results, analysis methods, and the study’s sample-size justification are not reported in the registry record.