Addressing Cancer-Related Financial Toxicity in North Carolina Oncology Care Settings: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Addressing Cancer-Related Financial Toxicity in North Carolina Oncology Care Settings (NCT04931251), a na na study. The primary outcome is COST (Comprehensive Score for Financial Toxicity) Measure.

2. Clinical Question

The study addresses financial toxicity, meaning the material, psychological, and behavioral burden associated with the costs of cancer care. Its stated purpose is to evaluate financial navigation and patient outcomes, including financial toxicity and health-related quality of life, in community oncology settings. Rural and non-rural practice settings are both part of the study context, but the record does not report separate outcome estimates by setting.

This is a question about change observed among participants receiving navigation, not a direct comparison of navigation with usual care or another assigned intervention. Consequently, even a change between surveys would not, by itself, establish what would have happened over the same period without navigation. The registry record contains no reported primary outcome analysis with which to characterize the observed change.

3. Trial Design

This is a completed, single-group behavioral intervention study sponsored by UNC Lineberger Comprehensive Cancer Center. Its registry identifier is NCT04931251, and its title is “Addressing Cancer-Related Financial Toxicity in North Carolina Oncology Care Settings.” The official title specifies rural and non-rural North Carolina oncology care settings. The record lists the phase as NA, allocation as NA, and masking as none. It reports enrollment of 205 participants.

The intervention is Financial Navigation, delivered in 4 rural and 4 non-rural oncology practices. The intervention description includes screening with COST, baseline and post-intervention surveys, and approximately 2-6 navigator visits to identify financial assistance resources. This design makes the participant their own reference across the two survey occasions, but it does not create a concurrent untreated group. Differences between baseline and follow-up can therefore reflect changes over time as well as any intervention-associated change.

The study started on 2021-11-11, had a primary completion date of 2025-07-31, and is listed as completed. The primary outcome is the COST measure at 4-6 months. Health-related quality-of-life measures are listed as a secondary outcome. The registry reports 2 outcome measures and 0 analyses. Thus the record identifies outcomes and their intended timing but does not give numerical results or an analysis estimate for them.

The registry record does not report a randomized allocation, blinding, or a control arm. Nor does it report a protocol-level statistical analysis plan, the rationale for the enrollment target, or whether any interim analyses were planned. Those features should not be inferred from the single-group design or from the fact that the study is listed as completed.

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: A total of 258 participants were screened for eligibility. Of these, 233 met the inclusion criteria and screened positive for financial toxicity (COST score ≤22). Among eligible participants, 205 enrolled and initiated the financial navigation intervention, 179 completed the intervention, and 134 completed both pre- and post-intervention surveys. Consented participants who screened negative for financial toxicity at baseline (COST score \>22, indicating low financial distress) were not eligible.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants completed both the baseline and follow-up survey.

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: Participants began the financial navigation intervention.

6. Primary Endpoint

The registry lists the primary outcome as COST (Comprehensive Score for Financial Toxicity) Measure, measured over 4-6 months.

The primary endpoint is the Comprehensive Score for Financial Toxicity, or FACIT-COST, measured before and after financial navigation. It is a 12-item measure with scores ranging from 0 to 44. Its direction is important to interpretation: higher values indicate lower financial toxicity and less financial distress, while lower values indicate greater financial toxicity and more distress. An increase in score from baseline to follow-up would therefore indicate improvement on the measure; a decrease would indicate worsening financial toxicity.

The endpoint is used to quantify participants’ reported financial burden in a way that can be compared across the two survey occasions. The registry describes the primary outcome as a mean score and gives a 4-6 month timeframe. It specifies that the relevant population consists of participants who completed both baseline and follow-up surveys. This definition does not tell us how many participants completed both surveys, nor does it provide their baseline or follow-up means, standard deviations, or change estimate.

The distinction between a measure’s direction and a trial result matters. Knowing that higher scores correspond to less distress clarifies how an estimated change would be read, but it does not establish whether scores actually increased or decreased. The registry record does not report the primary endpoint results, an interval estimate, or a test of change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The method that can be described from the registry is a single-group assessment of a continuous score at baseline and follow-up. The primary measure is summarized by a mean and standard deviation according to the outcome description. These are descriptive quantities: the mean locates the center of the observed scores, while the standard deviation describes how spread out individual scores are around that mean. Neither quantity alone indicates how precisely the average change has been estimated.

What does a baseline-to-follow-up comparison represent?

When the same participants complete surveys on both occasions, the natural contrast is within-person change: each participant’s follow-up score is compared with their baseline score, and those changes can then be summarized across participants. This approach recognizes that observations from one person are related rather than independent. The registry specifies that the primary population completed both surveys, but it does not report the number of such participants or the statistical procedure used to compare their scores.

There are different possible ways to analyze repeated continuous measurements. A paired analysis can directly summarize participant-level changes; a model can also represent repeated observations and potentially account for other features of the data. Those are general options, not a description of what this study did. The statistical analysis method is not reported in the registry record. It would be inappropriate to attribute a paired test, a regression model, an adjustment set, or any other specific method to the study without a reported analysis.

How should uncertainty be understood?

In general, a confidence interval describes a range of values compatible with the data and the assumptions of the method used. For a mean change, it helps readers judge both the estimated direction and the precision of that estimate. A narrow interval indicates greater precision than a wide interval, while an interval that includes values in different directions can leave the direction uncertain. These general principles do not supply an estimate for this study: the registry record does not report a confidence interval or a mean change.

A p-value, in general, summarizes how surprising data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the analysis assumptions were true. It does not give the size or practical importance of a difference, and it is not the probability that the null hypothesis is true. No p-value or hypothesis test is reported in the registry record. Without an estimate and its uncertainty, statistical significance cannot be assessed, and statistical significance would not by itself establish a causal effect in a single-group design.

Why does the design matter for inference?

Because the study has one group, baseline is a historical measurement for the participants rather than a concurrent control. A within-person analysis can describe how scores changed among those observed at both times. It cannot, on its own, identify the counterfactual change that would have occurred without navigation. General influences over time, changes in circumstances, and selection into follow-up can complicate causal interpretation. The registry does not report whether or how the analysis addressed these issues.

Mean change is also only one summary of a distribution. Participants can have different directions and sizes of change even when the group mean moves in one direction. A standard deviation describes variability in scores, but it does not show the full distribution or explain why participants differ. The record does not report distributions, subgroup estimates, or individual-level patterns. Such details should not be inferred from the outcome’s mean-and-standard-deviation description.

How do planning calculations differ from trial results?

General sample-size calculations estimate how many participants would be needed under stated assumptions to detect a specified effect with a chosen error rate and power. Any such calculation is a planning illustration, not an observed result and not “observed power.” The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of an observed effect. Those assumptions do not turn this single-group study into a two-arm comparison, nor do they establish that those were the design assumptions used to enroll participants. The record does not report the study’s own sample-size justification. No sample-size estimate should be interpreted as an outcome or as evidence that a result was detected.

For time-to-event outcomes, some planning methods count total events; for other outcomes, planning quantities may be expressed as participants per arm. That general distinction does not change the primary endpoint here, which is a continuous score, or supply an unreported trial analysis. The registry reports no analysis results, so the available information supports explanation of the outcome and design, but not reconstruction of an inferential result.

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("Baseline Financial Navigation", "Follow-up Financial Navigation")
n   <- c(134, 134)
m   <- c(6.6, 14.7)
sp  <- c(5.1, 10.2)
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  Baseline Financial Navigation  134  6.600  5.100  5.729  7.471
CARM  Follow-up Financial Navigation  134  14.700  10.200  12.957  16.443

11. Multiplicity, Missing Data and Analysis Populations

The registry lists the COST measure as the primary outcome and health-related quality-of-life measures as a secondary outcome. It reports 2 outcome measures and 0 analyses. The record does not report a multiplicity strategy describing how inference across outcomes, time points, or any other analyses was handled. It also does not report which outcome measures were included in any formal hypothesis-testing family. Without those details or reported analyses, the possible effect of multiple testing cannot be evaluated.

The primary outcome population is described as participants who completed both baseline and follow-up surveys. The registry does not give the number of participants with complete paired measurements, the number missing either survey, or reasons for missingness. It does not report whether missing observations were excluded, imputed, or handled using a model, nor does it provide sensitivity analyses. Consequently, the potential impact of missing follow-up data on the endpoint estimate is not assessable from this record.

The study enrolled 205 participants, but the outcome description’s complete-survey population is not accompanied by a completion count. Enrollment therefore should not be treated as the denominator for the primary analysis without further information. The registry also does not describe a broader intention-to-treat population, a per-protocol population, or other analysis populations. The absence of these details in the registry does not establish that no procedures were used; it means they are not reported in the registry record.

The record does not report a statistical analysis plan, prespecified decision rules, or interim analysis procedures. These gaps limit assessment of whether analyses followed an advance plan and whether all relevant outcomes are represented in the posted results. Since no analyses are reported, there are no reported estimates to assess for multiplicity or missing-data sensitivity.

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.

For the Financial Navigation group, the registry lists 205 participants at risk for serious adverse events and 0 affected by a serious adverse event. It also lists 205 at risk for other adverse events and 0 affected by other adverse events. The same group has 5 deaths recorded. These are registry counts; the record does not provide details about the causes, timing, or relationship of the deaths to the intervention.

The zero entries mean that no affected participants are recorded in those adverse-event fields. They should not be expanded into a claim that no health events occurred, that all possible events were captured, or that the intervention is free of risk. The registry record does not describe ascertainment procedures or provide event narratives. In particular, the death count should not be combined with or interpreted as a count of intervention-related deaths when attribution is not reported.

These data come from a single-group study, with no concurrent comparator described. The counts therefore do not provide a comparative estimate of safety between navigation and another care approach. The registry’s safety entries can be stated as recorded, while their clinical interpretation remains limited by the lack of event details and comparative data.

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

The study is relevant to a practical research question: whether financial navigation delivered in community oncology settings is accompanied by changes in reported financial toxicity and health-related quality of life. Its context includes rural and non-rural practices in North Carolina, and its intervention description includes screening, surveys, and navigator visits to identify financial assistance resources. The primary measure has an explicit interpretation, with higher FACIT-COST scores corresponding to less financial distress.

What the registry record does not establish is the observed direction, size, or precision of the change. No primary outcome summary or statistical analysis is reported. Thus, the record cannot support a statement that participants’ financial toxicity improved, worsened, or did not change. The same caution applies to the secondary health-related quality-of-life outcome: it is listed, but no result is reported.

Even if a before-and-after estimate were available, this single-group design would describe change among observed participants rather than isolate the causal effect of navigation. Without a concurrent comparison group, changes attributable to other influences over time cannot be separated from changes associated with the intervention. The record also does not provide the number completing both surveys, which limits understanding of whose paired outcomes would contribute to an estimate.

The findings should therefore be distinguished from the rationale for conducting the study. The stated motivation is that financial toxicity is consequential and growing, particularly for rural patients, and that the effects of financial navigation warrant evaluation. That rationale explains the research question; it is not evidence of the intervention’s outcome in this study. Likewise, the description of navigator visits and assistance resources tells readers what the intervention involved, not whether it changed scores.

The registry information is useful for understanding the design and outcome definition, but it is insufficient for judging the magnitude or reliability of an outcome change. It also does not establish whether findings differ between rural and non-rural settings, or whether any observed changes would generalize beyond the participating practices and enrolled participants.

14. Why This Trial Matters Statistically

Financial toxicity is not represented as a purely financial accounting measure. The study’s rationale connects cancer-care costs with material, psychological, and behavioral burdens, while its primary measure captures participants’ reported financial distress. Statistically, that makes clear outcome definition important: a score change needs to be interpreted according to the measure’s direction, and the FACIT-COST scale is oriented so higher scores mean lower financial toxicity.

The design also highlights a central distinction in clinical research between describing change and estimating an intervention effect. Repeated measurements can show how outcomes among the observed participants differ over time. A concurrent comparison is generally needed to distinguish that temporal change from the change that might have occurred without the intervention. The single-group structure means that distinction remains important when interpreting any change estimate.

Practice setting is part of the study’s motivation and delivery, with navigation conducted in rural and non-rural oncology practices. That context makes it important to know whether results are reported for each setting and how much information supports such estimates. The registry record does not report setting-specific results, so it cannot establish whether outcomes differed between rural and non-rural practices.

Finally, statistical interpretation depends on more than a point estimate. Precision, missing follow-up information, and the population included in analysis affect how much confidence readers can place in an estimated change. The registry record does not report the primary results, uncertainty, completion counts, or analysis procedures. These omissions make the record informative about the study question and structure, but not sufficient to evaluate the size or reliability of its outcome findings.

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 main limitation for interpreting this specific record is that it does not report the primary outcome results or statistical analyses. The endpoint is defined in detail, but no baseline or follow-up summary, change estimate, uncertainty interval, or test result is available. This prevents assessment of the observed direction, magnitude, and precision of change in financial toxicity.

The single-group design has no concurrent control comparison. Any observed change would therefore be a within-group temporal contrast, not a direct estimate of what navigation changed relative to another care approach. The registry does not report a strategy for addressing other time-related influences or differences in follow-up participation.

The outcome population is defined as participants completing both surveys, but the record does not state how many did so. Without that count, it is not possible to assess follow-up completeness or determine how the analyzed group relates to the 205 enrolled participants. Missing-data methods and sensitivity analyses are also not reported.

The registry includes rural and non-rural practice settings but provides no setting-specific outcome results. It also does not report detailed intervention delivery or participant-level exposure beyond the description of approximately 2-6 navigator visits. Whether visit uptake varied, or how it related to outcomes, is not reported in the registry record.

Finally, the record does not report the study’s statistical analysis plan, sample-size justification, or multiplicity approach. Safety entries include 5 deaths without cause or attribution details. These limitations do not establish that the study lacked further documentation; they constrain what can be concluded from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Addressing Cancer-Related Financial Toxicity in North Carolina Oncology Care Settings — NCT04931251.
• Registry record last updated 2026-10-07; status last verified 2026-09.
• Results first posted 2026-10-07.
• 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

NCT04931251 is a completed, single-group behavioral study of Financial Navigation in rural and non-rural North Carolina oncology practices. The registry reports enrollment of 205 participants and a primary outcome of FACIT-COST score at 4-6 months. The measure ranges from 0 to 44, with higher scores indicating lower financial toxicity. The intervention description includes screening, surveys, and approximately 2-6 financial navigator visits to identify assistance resources.

The registry lists health-related quality-of-life measures as a secondary outcome, 2 outcome measures, and 0 analyses. It does not report the primary outcome results, statistical estimates, missing-data handling, or a concurrent comparator. Safety entries list 0 serious adverse events affected and 5 deaths in the intervention group, without cause or attribution details. The record supports a description of the study design and measurement, but not a conclusion about the observed change or the intervention’s causal effect.