Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer (NCT04520061), a randomized na study. The primary outcome is Acceptability of the Health Insurance Navigation Program.

2. Clinical Question

3. Trial Design

The registry record describes a completed, randomized, parallel-group study with no masking. It lists phase as NA and enrollment as 82. The study was sponsored by Massachusetts General Hospital. The recorded start date is 2020-08-25, and the primary completion date is 2022-12-31. The study title and stated aims frame it as developing and piloting a health insurance navigation program for survivors of childhood cancer, with attention to feasibility, acceptability, insurance literacy, and financial distress related to medical costs.

The navigation program was planned as synchronous videoconferencing with a trained patient navigator: 4 weekly sessions, each 30 minutes, spanning one month. Enhanced usual care consisted of an online or mailed health insurance resource guide. These are the intervention descriptions in the registry record; details such as the randomization procedure, allocation concealment, and adherence to the intended schedule are not reported in the registry record.

The primary endpoint was acceptability at 5 month follow-up. It was designed for the intervention group only, and the record explicitly says the enhanced usual care group did not complete the acceptability measures for that reason. The posted primary result therefore describes the intervention group and cannot serve as a randomized comparison between groups.

The record identifies two secondary outcomes, both assessed as change from baseline to 5-month follow-up: familiarity with ACA provisions and health insurance literacy. Each has posted results for both groups and an unadjusted recalculated comparison. The registry record reports no sponsor-reported analyses for these outcomes. Further details about the planned statistical analysis, participant flow, analysis population, or handling of missing observations are not reported in 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The EUC did not complete acceptability measures as it was intended only for the intervention group.

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 consented and completed the baseline survey.

6. Primary Endpoint

The registry lists the primary outcome as Acceptability of the Health Insurance Navigation Program, measured over 5 month follow-up.

The primary endpoint is acceptability of the health insurance navigation program at 5 month follow-up. It is measured as a mean score on an investigator-created 10-point scale, where 1 means least helpful and 10 means most helpful. The scale covers program materials, scheduling, communication with the navigator, and the length and number of sessions. Higher scores indicate higher acceptability.

Acceptability is relevant to a program-development and pilot study because a service can be assessed for how participants experience its materials, delivery, communication, and session format. Such information can help characterize whether the intervention is acceptable to those receiving it. As a general statistical point, a mean describes the central level of scores, while the standard deviation describes how spread out individual scores are around that mean.

The navigation group’s posted mean was 8.9 units, with a standard deviation of 1.2, based on 37.0 participants. The enhanced usual care group did not complete acceptability measures because the endpoint was intended only for the intervention group. Thus, the endpoint gives a descriptive assessment of intervention acceptability rather than evidence of a difference in acceptability between randomized groups. It also does not directly measure insurance literacy, insurance status, or financial distress.

The registry record does not report details about the scale’s validation, scoring procedures beyond the stated range and domains, or the distribution of individual responses. It also does not report a confidence interval for the mean. Those omissions limit how fully the precision and measurement properties of the acceptability result can be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design is randomized and parallel, with no masking recorded. In a randomized comparison, assignment is intended to make the groups comparable on average, so a difference in outcomes can be interpreted in relation to the assigned intervention under the analysis assumptions. The registry record does not describe the random sequence generation, allocation concealment, or the statistical model used by the investigators. It therefore is not possible to assess those design and analysis details from the registry record.

What does the primary mean describe?

The primary result is a mean, which is a measure of the average score in the navigation group. The posted mean is 8.9 units and the standard deviation is 1.2, with 37.0 participants contributing to the result. The standard deviation characterizes variability among participant scores; it is not a confidence interval and does not directly state how precisely the mean has been estimated. The registry record does not provide a confidence interval for this mean.

The primary endpoint was intended only for the intervention group. A group mean can describe acceptability among participants who completed the measure, but it cannot estimate a treatment contrast without a corresponding comparator measurement. The record explains that enhanced usual care did not complete the acceptability measure by design. That makes the lack of a control result different from a missing control value that might otherwise have been expected under the endpoint plan.

How should the secondary mean differences be read?

The secondary outcomes are continuous measures expressed in scale units. The posted values are mean changes from baseline to 5-month follow-up. The recalculated comparisons subtract the enhanced usual care mean change from the navigation mean change, using the posted summary statistics. For familiarity with ACA provisions, the reported recalculated mean difference is 1.2 units, with a 95% confidence interval from 0.461 to 1.939. For health insurance literacy, it is 7.3 units, with a 95% confidence interval from 3.837 to 10.76.

A confidence interval represents uncertainty around an estimated quantity under the assumptions used to construct it. It is not a range containing a known proportion of individual participant outcomes, and it does not correct for bias, missing data, or unreported analysis choices. The intervals are recalculated from the posted summary statistics and are not investigator-reported confidence intervals. The registry record reports no sponsor analyses for these secondary endpoints.

The associated unadjusted p-values are 0.001 for familiarity with ACA provisions and <0.001 for health insurance literacy. A p-value measures compatibility between the observed result and a specified null model, conditional on the analysis assumptions. It is not a measure of effect size or practical importance. Since the analyses are unadjusted and multiplicity procedures are not reported in the registry record, these p-values should not be treated as confirmatory tests in isolation.

Why do spread and sample size matter?

For a continuous outcome, the standard deviation summarizes the spread of individual values. Greater variability generally makes a group mean less precise when other features are similar. The posted standard deviations for the secondary change outcomes are 1.7 and 1.6 for familiarity with ACA provisions, and 7.6 and 7.9 for health insurance literacy, for navigation and enhanced usual care respectively. The recalculated comparisons use the reported group sizes and summary statistics. The record does not provide individual-level data, so alternative analyses of distributions, outliers, or covariate adjustment cannot be assessed.

General statistical context: when the assumptions of a simple mean-based comparison are reasonable, the standard error quantifies the expected sampling variability of the estimated mean or contrast. A confidence interval is built from that uncertainty. These calculations do not by themselves establish that the assumptions hold, and the registry record does not report diagnostics or a detailed model specification.

What do the planning illustrations mean?

The posted planning illustrations use the observed secondary effect as a starting point and show hypothetical participants per arm for 80% power and for 90% power when planning for 100% of the observed effect, 75% of the observed effect, or 50% of the observed effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. For familiarity with ACA provisions, the illustrations range from 30 participants per arm for 80% power when planning for 100% of the observed effect, to 119 participants per arm when planning for 50% of the observed effect; the corresponding 90% power illustrations are 40 and 159 participants per arm. For health insurance literacy, the corresponding 80% power values are 18 and 71 participants per arm, and the 90% power values are 24 and 95 participants per arm.

These are planning illustrations based on observed effects, not observed power and not the trial’s own design justification. They are sensitive to the assumed effect size: planning for a smaller effect requires more participants per arm under the stated assumptions. The registry record does not report the study’s sample-size justification or a prespecified target effect for the trial. The illustrations should not be mistaken for evidence that the trial was planned or powered according to those assumptions.

What cannot be evaluated from the registry analysis?

The registry record does not report an analysis plan, a multiplicity strategy, missing-data methods, or analysis-population definitions. It also does not report whether analyses adjusted for baseline values or other variables. These are not details that can be inferred from the posted means and standard deviations. As a general point, transparent reporting of these decisions helps readers judge whether estimates were prespecified, how participants with incomplete data were handled, and how much confidence to place in secondary comparisons.

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("Navigation Intervention")
n   <- c(37)
m   <- c(8.9)
sp  <- c(1.2)
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  Navigation Intervention  37  8.900  1.200  8.500  9.300

11. Multiplicity, Missing Data and Analysis Populations

The registry record identifies a primary acceptability endpoint and two secondary outcomes, but it does not report a statistical analysis plan or a multiplicity adjustment. The two secondary p-values are unadjusted. When several outcomes are examined, the chance of encountering a nominally unusual result can rise even if no true difference exists. This is why unadjusted secondary comparisons are generally interpreted as exploratory unless the analysis plan establishes how the outcomes and error rates will be handled. No such plan is reported in the registry record.

Missing-data handling is also not reported in the registry record. The primary endpoint includes a navigation-group result based on 37.0 participants, while the enhanced usual care group did not complete acceptability measures by design. That comparator absence is built into the stated endpoint intent and means that the primary result is descriptive rather than comparative. For the secondary outcomes, the posted group counts are 37.0 and 40.0 participants for both endpoints. The record does not describe whether these counts represent all randomized participants with available observations, how incomplete follow-up was handled, or whether any imputation or sensitivity analysis was used.

The analysis population is not reported in the registry record. It is therefore not possible to determine whether the posted estimates use an intention-to-treat population, a per-protocol population, or another defined set of participants. The record also does not explain whether participants were analyzed according to randomized assignment or whether any departures from assignment were considered.

These omissions do not change the posted values, but they constrain interpretation. Without a reported analysis plan, multiplicity procedure, missing-data approach, and analysis population, readers cannot determine whether the secondary comparisons were prespecified or how robust they might be to alternative choices. The recalculated estimates are straightforward comparisons of the posted summaries, but they cannot replace an investigator analysis that accounts for the full trial design and documented participant-level data.

12. 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 posted serious adverse event figures list 41 participants at risk in each group, with 0 serious adverse events in the navigation group and 0 in enhanced usual care. The figures also list 41 participants at risk in each group for other adverse events, with 0 in both groups, and deaths are listed as 0 in both groups. These counts describe the safety data reported in the registry record.

Zero reported events means that no events of the listed type were recorded in these reported group figures. It does not establish that the risk of an event is absent, nor does it show that the groups have equivalent safety profiles. With no events recorded, a comparative event-rate estimate cannot be derived from the posted figures. The registry record does not report additional details about event collection, definitions, observation time, or whether adverse-event ascertainment was complete.

The at-risk counts for safety are not the same as the denominators reported for the primary acceptability endpoint or secondary outcomes. The record does not explain the relationship between those counts and the endpoint-specific participants, so they should not be reconciled by assumption. These figures are a registry safety summary, not a substitute for a detailed adverse-event analysis.

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

The primary result tells readers how participants in the navigation group rated the program’s acceptability at 5 month follow-up. The mean rating was 8.9 units on a scale where higher values indicate greater acceptability. It supports a description of reported participant experience among those represented in that result. Because enhanced usual care did not complete the acceptability measure, it does not show whether acceptability was higher than for the resource guide or whether navigation caused a difference in acceptability.

The secondary results describe changes in insurance familiarity and literacy in both groups. The unadjusted recalculated comparisons favor greater mean change in the navigation group for each posted measure. They are relevant to the intervention’s stated aims, but they remain secondary, unadjusted comparisons based on summary statistics. Their interpretation is limited by the absence of a reported analysis plan, missing-data methods, multiplicity approach, and analysis-population definition.

These outcomes do not establish that participants became insured, obtained more comprehensive insurance, reduced financial distress, or experienced different medical outcomes. Insurance status and financial distress are mentioned as motivations and aims in the registry summary, but the posted results described in the record are acceptability and changes in familiarity and literacy. The findings should not be extended to outcomes that were not reported.

The study is described as a development and pilot effort. Pilot findings can characterize delivery and generate estimates that may inform later research, but they do not automatically answer whether results would be reproduced in a larger or different setting. The planning illustrations are hypothetical calculations using observed effects and stated assumptions; they are not evidence of observed power or of the study’s original design rationale. Overall, the registry record documents a favorable intervention-group acceptability mean and positive-direction secondary contrasts, while leaving important questions about comparative analysis and uncertainty unresolved.

14. Why This Trial Matters Statistically

This trial is statistically informative because its primary outcome and secondary outcomes answer different questions. The acceptability measure was designed for the navigation arm alone, which is appropriate to describing participant experience but does not create a randomized comparison. The secondary outcomes include both groups and permit unadjusted contrasts, but those analyses are not reported as sponsor analyses and are not described within a posted analysis plan. Keeping these distinctions clear prevents a descriptive mean from being mistaken for a treatment effect.

The record also illustrates why outcome-specific denominators matter. The primary result and secondary results have their own reported participant counts, and the safety summary uses different at-risk counts. The registry record does not explain the relationship among these denominators. Treating them as interchangeable would assume participant flow or endpoint availability that is not reported.

Another important issue is the status of secondary evidence. The calculated mean differences and confidence intervals quantify contrasts from posted summary statistics, but the comparisons are unadjusted and the multiplicity approach is not reported. This makes statistical significance alone an incomplete guide to evidential strength. Confidence intervals, endpoint purpose, analysis reporting, and missing-data information all contribute to a careful reading.

Finally, the planning illustrations show how sample-size requirements depend on the effect assumed for future planning. They are explicitly based on observed effects and stated assumptions, rather than the trial’s original design. That distinction matters in a pilot: observed effects can be imprecise, and using them as planning inputs does not establish that the study had adequate power for a confirmatory question. The registry record does not report its own sample-size justification. These features make the study useful for understanding the statistical boundaries of pilot evidence as well as its posted outcome pattern.

15. 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 primary endpoint is not comparative. Enhanced usual care did not complete the acceptability measure because it was intended only for the intervention group. The reported mean therefore cannot estimate a between-group difference, and no control-group acceptability result is available in the registry record. The acceptability measure is described as investigator-created; its validation and measurement properties are not reported in the registry record.

The posted primary result gives a mean and standard deviation but no confidence interval. As a result, the registry record does not directly show the uncertainty around the mean. The secondary estimates are recalculated from summary statistics rather than reported investigator analyses. The registry record does not provide individual-level data, adjusted analyses, or diagnostic information that would allow further assessment of distributional assumptions or influential observations.

For the secondary outcomes, the analyses are unadjusted and no multiplicity procedure is reported. The record does not explain how missing observations were handled, define the analysis population, or state whether the comparisons were prespecified. These gaps limit the strength of causal and confirmatory interpretation. The endpoint counts differ from the safety at-risk counts, and the registry record does not explain why.

The study is identified as a pilot, and the intervention is a specific navigator-led videoconferencing program with a resource-guide comparator. The registry record does not report further details about participant characteristics, recruitment, adherence, implementation fidelity, or the representativeness of those completing follow-up. Without those details, applicability to other populations or delivery settings cannot be assessed from the posted record. The stated aims include financial distress, but no financial-distress result is included among the posted endpoints.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer — NCT04520061.
• Registry record last updated 2025-02-03; status last verified 2025-01.
• Results first posted 2025-02-03.
• 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.

19. Record Summary

The registry record describes a completed randomized, parallel-group study with no masking, phase listed as NA, and enrollment of 82. The study evaluated a navigator-led health insurance navigation program against enhanced usual care consisting of an online or mailed resource guide. The primary endpoint was acceptability at 5 month follow-up, measured only in the intervention group.

The navigation group’s mean acceptability rating was 8.9 units, with a standard deviation of 1.2, among 37.0 participants. Two secondary outcomes were posted: change in familiarity with ACA provisions and change in health insurance literacy. Both have unadjusted recalculated group comparisons; sponsor analyses are not reported. Safety figures list no serious adverse events, other adverse events, or deaths in either group. The registry record does not report the statistical analysis plan, multiplicity handling, missing-data methods, or analysis population.