Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2 (NCT04179305), a non-randomized na study. The primary outcome is Change in Prognostic Understanding.

2. Clinical Question

The outcome focuses on whether patients recognize that their disease is incurable and advanced, and whether they expect to live months rather than years. These topics are relevant to the intervention because the training aims to guide how physicians communicate prognosis and expected treatment outcomes. The study description explains the rationale in terms of patients understanding their illness and its implications; it does not establish that the intervention changed understanding or any later care outcome.

3. Trial Design

The study is titled “Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2.” Its phase is listed as NA. The record describes a parallel, single-masked, nonrandomized study with an enrollment of 37 and a completed status. The listed study start date is 2020-10-25, and the primary completion date is 2022-07-25. Weill Medical College of Cornell University is the sponsor.

The study includes patient and physician arms. Physicians in the Oncolo-GIST arm received the training intervention; physicians in the usual-care arm did not. Patients in the intervention arm discussed progressive scan results with an Oncolo-GIST-trained physician, while patients in usual care discussed those results with an untrained physician. The primary endpoint concerns patient prognostic understanding, not physician outcomes.

Because allocation was nonrandomized, the arms are not a like-for-like randomized comparison. Differences between groups could reflect factors other than training, including how participants came to be in each arm. The registry record does not report the allocation procedure, baseline comparability, the identity of the masked party, or details of how masking was maintained. It also does not report the planned sample-size justification or a full statistical analysis plan.

The registry describes a baseline assessment and a follow-up in the week after the scan. Assessments at 2- and 4-months were ultimately not done because participants preferred not to commit to follow-up. The record lists seven outcome measures, including patient quality of life, whether a do-not-resuscitate order was made, treatment and care received, and patient performance status. It reports zero analyses in its analysis listing; that does not establish whether analyses were performed outside the registry record.

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: Group assignment was not random, but was based on the arm of the participating patient's physician: GIST-trained or usual care. Screening for cognitive deficit and health literacy occurred prior to enrollment. Following enrollment, one patient withdrew due to time constraints and one was lost to follow-up.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 1 patient on the Oncolo-GIST arm was not analyzed due to not having completed the post-scan visit interview. Not relevant to Physician arm participants. The investigators did not include one item from the validated 4-item scale (terminal illness acknowledgement) in the follow-up assessment due to technical error, and so the measure was limited to the three items for which there was follow-up data. 2- and - 4-month assessments were not done as participants preferred not to commit to follow-up.

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 participants who completed the Baseline Survey.

6. Primary Endpoint

The registry lists the primary outcome as Change in Prognostic Understanding, measured over Baseline; week after scan. 2- and - 4-month assessments were ultimately not done as participants preferred not to commit to follow-up..

The primary endpoint is change in prognostic understanding, measured in units on a scale. The registry describes questions about recognition of incurable disease, knowledge that the disease is at an advanced stage, and expectation of living months rather than years. Responses are coded to indicate whether each element is present. A summary score is used, and change is defined as the post-scan score minus the baseline score. Higher change scores represent increased understanding; lower scores represent decreased understanding.

This endpoint is intended to capture whether communication is associated with patients recognizing important aspects of their prognosis. It measures reported understanding rather than treatment decisions, quality of life, or care received. Those topics appear among the secondary outcomes, but they are not substitutes for the primary measure.

The registry’s endpoint description refers to three questions from a validated four-item assessment, while also describing four indicators and a score ranging from 0 to 3. It says that one item concerning terminal illness acknowledgement was not included in the follow-up assessment. This wording leaves the scoring details unclear. The record also identifies a mean and standard deviation as the summary format, but does not report the observed endpoint values, the amount of change, or a group comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous: it is a score, and the registry identifies the mean and standard deviation as its summary format. No actual means or standard deviations are reported in the registry record. The record also does not specify the statistical test, model, covariates, or procedure used to compare changes between groups.

What does a mean describe?

General statistical explanation: A mean is an average that locates the center of a set of measurements. For a change score, the mean describes the average change among the observations included in that calculation. It does not show whether every participant changed in the same direction, and it can be influenced by unusually high or low values. The score’s definition and the participants included in the calculation are therefore important to interpretation.

A standard deviation describes how spread out individual measurements are around their mean. It is not a measure of uncertainty in the mean itself. A group can have a small standard deviation while the estimated mean remains imprecise if few observations contribute, or a larger standard deviation with a more precise mean when more observations contribute. The record identifies standard deviation as the dispersion measure but gives no observed values from which to assess spread.

How should a confidence interval be read?

General statistical explanation: A confidence interval expresses the uncertainty around an estimate under the assumptions of the method used to calculate it. A narrower interval indicates greater precision than a wider interval, but neither width nor location alone establishes that an effect is clinically important. The interval should be interpreted alongside the outcome scale, the estimated difference, study design, and possible sources of bias. No confidence interval is reported for this endpoint in the registry record.

A p-value, if reported, would describe how compatible the observed data are with a specified statistical null model under its assumptions. It would not measure the probability that the intervention works, nor would it quantify the size or importance of a difference. The registry record does not report a p-value or the statistical test to which one might relate.

Why does nonrandomized allocation matter?

General statistical explanation: Random assignment is one way to balance measured and unmeasured factors between comparison groups, on average. With nonrandomized allocation, group differences can reflect the intervention, pre-existing differences, or both. Statistical adjustment can address measured factors when appropriate data and a prespecified approach are available, but it cannot automatically remove bias from unmeasured factors. The registry identifies nonrandomized allocation and explicitly notes that the arms are not a like-for-like control comparison. It does not report an adjustment model or enough detail to judge how confounding was addressed.

What does over-dispersion mean for count outcomes?

General statistical explanation: Over-dispersion occurs when count data vary more than a statistical model expects. If ignored, the model can understate uncertainty and make estimates appear more precise than they are. This concept may matter for outcomes recorded as counts, but the registry entries do not identify count-based primary outcomes or report analyses of such outcomes. It is not possible to say whether over-dispersion was assessed or relevant to the posted analyses.

How should planning illustrations be understood?

The stated sample-size assumptions describe a planning illustration based on the observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. For this non-time-to-event setting, the stated convention is participants per arm. No observed effect or resulting planning counts are included in the registry entries, so no sample-size value can be interpreted.

General statistical explanation: A sample-size calculation asks how many observations would be needed under stated assumptions to detect a chosen effect with a target probability of detecting it, if that effect were present. Such a calculation depends on assumptions about variability, significance threshold, allocation, and effect size. A calculation made after observing results is a planning illustration, not evidence that the study had a particular probability of success before it began. It is not “observed power.” In this record, the illustration is explicitly separate from the trial’s own design, and no sample-size justification for the trial is reported.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Oncolo-GIST Arm - Patients", "Usual Care Arm - Patients")
n   <- c(12, 11)
m   <- c(0.58, 0.18)
sp  <- c(1, 1.25)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Oncolo-GIST Arm - Patients  12  0.580  1.000  -0.055  1.215
CARM  Usual Care Arm - Patients  11  0.180  1.250  -0.660  1.020

11. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures, while the primary endpoint is change in prognostic understanding. Considering multiple outcomes can raise the chance of at least one apparently notable result when many statistical tests are conducted. General statistical explanation: Multiplicity refers to the challenge of interpreting a family of tests rather than a single prespecified test. Methods can control error rates or organize outcomes into primary and secondary questions, but the appropriate approach depends on the study’s objectives and analysis plan. Whether multiplicity was addressed, and how, is not reported in the registry record.

The record lists zero analyses. It therefore does not provide analysis-specific details such as test selection, model form, covariate adjustment, handling of repeated measurements, or confidence intervals. The absence of those details in the record should not be read as proof that no analysis was conducted.

For the primary endpoint, one patient in the Oncolo-GIST arm was not analyzed because the post-scan interview was not completed. The record does not report an imputation method, a sensitivity analysis, or whether any other outcome data were missing. It also does not define an analysis population, such as whether participants were analyzed according to their original group assignment or according to assessments completed.

The registry states that the planned 2- and 4-month assessments were ultimately not done because participants preferred not to commit to follow-up. These uncollected assessments cannot contribute observed follow-up results. The record does not report whether other follow-up efforts or alternative data sources were used. The reason for omitting a terminal illness acknowledgement item from the follow-up assessment is incomplete in the registry description, so its implications for the score’s comparability across time are not fully clear.

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

The registry record shows that investigators intended to assess whether patients’ prognostic understanding changed between baseline and the post-scan interview, comparing patients whose physicians received Oncolo-GIST training with patients receiving usual care. It also documents the intervention’s communication focus and the nonrandomized design. It does not report the endpoint estimates or statistical comparisons needed to describe an observed effect.

Accordingly, the record does not establish whether scores increased, decreased, or remained similar in either group. It does not show how large a difference may have been, how precisely it was estimated, or whether a statistical analysis found evidence of a group difference. The lack of reported results is not evidence that there was no effect, just as the study’s rationale is not evidence that an effect occurred.

The outcome is a measure of prognostic understanding, not a direct measure of every consequence that might matter to patients. The listed secondary topics include quality of life, do-not-resuscitate orders, treatment and care received, and performance status. Their results are not reported in the registry record. The study description discusses potential reasons that understanding prognosis may matter, but those potential implications should not be mistaken for measured findings.

Nonrandomized allocation also limits causal interpretation. Any observed contrast, if results were available, could reflect group differences as well as the training. The record does not provide enough information to determine whether statistical adjustment could address such differences. In addition, one intervention-arm patient lacked the post-scan interview and the later planned assessments were not conducted. These features constrain what can be learned about outcome completeness and longer-term patterns.

13. Why This Trial Matters Statistically

This study raises a statistical question about evaluating a communication intervention through a patient-reported understanding score. The endpoint is defined as change from baseline to a post-scan follow-up, so interpretation depends both on the score’s construction and on having comparable measurements at each time. The registry’s account of three questions, four indicators, and omission of one item at follow-up makes the scoring description especially important to clarify.

The design also illustrates why comparison groups require careful interpretation. The arms differ in physician training, but allocation is nonrandomized. A statistical contrast alone cannot separate intervention effects from differences between the groups unless the design and analysis support that distinction. The registry record does not describe a strategy for doing so.

Missing follow-up matters because the primary outcome requires a post-scan assessment. One intervention-arm patient was not analyzed after not completing that interview, and the planned later assessments were not done. These registry entries highlight the value of specifying analysis populations, missing-data methods, and the intended role of each follow-up time point. Those details are not reported in the registry record.

Finally, the record includes a planning illustration based on an observed effect, separate from the study’s own design. This distinction matters: a retrospective illustration can describe assumptions for future planning, but it cannot replace a prospective sample-size rationale or establish the study’s power. Since the registry does not report the observed effect or the primary results, the illustration’s numerical implications cannot be evaluated from this record.

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 limitation for statistical interpretation is that the registry record does not report primary outcome values or analyses. Without group summaries, a comparison estimate, and an uncertainty measure, neither the magnitude nor precision of a difference can be assessed. The record also does not report the statistical analysis plan, any adjustment for group differences, or whether analysis decisions were prespecified.

Nonrandomized allocation limits the strength of causal conclusions. The record does not describe the allocation process, baseline group characteristics, or how potential confounding was handled. The listed single masking does not identify who was masked or how masking was implemented. These omissions make it difficult to assess the risk of bias from the record alone.

One patient assigned to the Oncolo-GIST patient arm was not analyzed because the post-scan interview was not completed. The handling of missing data beyond this stated exclusion is not reported. The 2- and 4-month assessments were not done because participants preferred not to commit to follow-up, limiting information about later outcomes. The registry does not report whether the score was analyzed consistently despite omission of an item at follow-up; its endpoint description is not fully clear about the number of questions and indicators.

The enrollment of 37 describes the study overall, but the registry entries do not provide complete primary-outcome analysis counts by arm. The record’s listing of seven outcome measures and zero analyses leaves multiplicity handling and outcome-specific methods unknown. The sample-size planning illustration is not the trial’s design justification, and the observed effect and resulting planning values are not reported in the registry entries.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2 — NCT04179305.
• Registry record last updated 2023-04-24; status last verified 2023-04.
• Results first posted 2023-04-24.
• 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

NCT04179305 is a completed, nonrandomized, parallel, single-masked study sponsored by Weill Medical College of Cornell University. The study title refers to Oncolo-GIST communication training in lung and GI cancer. Enrollment was 37; the listed start date was 2020-10-25 and primary completion date was 2022-07-25. The phase is listed as NA.

The primary outcome is change in patient prognostic understanding from baseline to the week after a scan. The record describes physician training in the Oncolo-GIST arm and usual care from untrained physicians in the comparator arm. It lists seven outcome measures, but reports zero analyses. Primary outcome results and the statistical plan are not reported in the registry record. One intervention-arm patient was not analyzed because the post-scan interview was not completed, and planned 2- and 4-month assessments were not done.