Shared Healthcare Actions and Reflections Electronic Systems in Survivorship: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Shared Healthcare Actions and Reflections Electronic Systems in Survivorship (NCT04337203), a na na study. The primary outcome is Number of Patients Enrolled Out of Those Electronically Referred.

2. Clinical Question

3. Trial Design

NCT04337203, titled Shared Healthcare Actions and Reflections Electronic Systems in Survivorship, evaluated the SHARE-S Implementation Program. The study is marked completed, with a listed enrollment of 40. Its start date is 2020-09-08 and its primary completion date is 2022-05-31. The listed phase is NA.

The design is single group, with allocation listed as NA and masking as none. Participants were not assigned to a parallel control group in the design described by the registry. The intervention is behavioral and comprises electronic referral, health coaching, and tailored text or email messages for patients referred to the survivorship clinic. The registry identifies Wake Forest University Health Sciences as the sponsor.

The study's stated purpose is to pilot-test study protocols, an implementation program, and mixed-methods data collection. Its primary endpoint concerns enrollment among electronically referred patients. Secondary outcomes cover adoption, acceptability, appropriateness, feasibility, enrollment per month, retention, text-response adherence, and adherence to coaching sessions. The registry lists 26 outcome measures, but detailed numerical results for these outcomes are not included in the record details.

A single-group pilot can describe implementation activity and participant responses, but it does not provide a concurrent control-group contrast. The registry does not report a randomized allocation procedure, and the listed allocation is NA. The study should therefore be read as an implementation pilot rather than as a controlled comparison of SHARE-S with another intervention or usual care. Further details about eligibility, recruitment procedures, and the operational definition of each secondary outcome 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: Total number reflects the total number of participants who were electronically referred in SHARE-S intervention.

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 Number of Patients Enrolled Out of Those Electronically Referred, measured over 1 year, 8 months.

The primary endpoint is titled “Number of Patients Enrolled Out of Those Electronically Referred.” It concerns enrollment among patients electronically referred to SHARE-S. The registry description says investigators will track the number of new patients seen in the Survivorship Clinic and the percent who agree to be referred to SHARE-S. The stated timeframe is 1 year, 8 months, and the specified summary is a 95% confidence interval.

This kind of endpoint is relevant to an implementation pilot because it describes whether referral is followed by participation. It can help characterize the reach of an implementation process, while the other listed measures address adoption, acceptability, appropriateness, feasibility, retention, and adherence. These outcomes address different aspects of implementation and should not be treated as interchangeable measures of clinical benefit.

In general, an enrollment count needs a clearly defined denominator to be interpreted as a rate or proportion. The registry describes the target as patients enrolled out of those electronically referred and says the total reflects participants electronically referred in SHARE-S. However, it does not report the numerical numerator, denominator, or confidence-interval limits for this primary endpoint. The enrollment figure of 40 is listed for the study, but the registry does not state that this number is the primary endpoint numerator or denominator. The endpoint's observed value and precision are therefore not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a number of participants and specifies a 95% confidence interval. The endpoint description focuses on the number enrolled out of those electronically referred. The record does not report a numerical estimate, the interval limits, or a detailed statistical analysis plan. It is therefore possible to explain the intended summary in general terms, but not to reconstruct the analysis or assess its result.

What does a confidence interval communicate?

In general, a confidence interval describes uncertainty around an estimate, using a method with a stated confidence level. For an enrollment endpoint, the estimate could be a count or, if numerator and denominator are defined, a proportion. The interval's interpretation depends on which quantity is estimated and how the interval is calculated. Here, the registry specifies a 95% confidence interval but does not report its numerical bounds or fully define the calculation. No conclusion about the endpoint's precision can be drawn from the confidence level alone.

A confidence interval is not a guarantee that the true value lies within the particular reported limits, nor does it indicate the probability that a treatment is effective. It is a way of expressing sampling uncertainty under the assumptions of a statistical method. In a pilot, the estimate can also be affected by recruitment, referral practices, eligibility, and data completeness. Details about those processes are not reported in the registry record.

Why does the denominator matter?

The endpoint title refers to enrolled patients out of electronically referred patients, while its description also mentions new patients seen in the Survivorship Clinic and the percent who agree to be referred to SHARE-S. These phrases point to related steps in a referral pathway, but the exact operational numerator and denominator are not reported. In general, a proportion is interpretable only when the included participants and the point at which they enter the denominator are clear. Different definitions of referral, eligibility, and enrollment can produce estimates that answer different questions. The registry's stated endpoint should not be converted into an unreported percentage.

The total enrollment is 40, but that study enrollment figure is not enough to reconstruct the primary endpoint. The record does not state how many patients were electronically referred, how many were eligible, or how many agreed to referral. Those counts and the endpoint estimate are not reported in the registry record.

What does the single-group design allow?

The model is listed as single group, allocation as NA, and masking as none. In general, single-group studies can describe what happened among participants in the study, but they do not supply a concurrent comparison for estimating a between-group effect. Observed uptake or adherence would be descriptive of the study setting. Without a comparison group, changes or participation cannot be attributed uniquely to the program on the basis of this design alone.

The registry's sample-size assumptions describe a planning illustration rather than the pilot's own design: two-sided significance level 0.05, equal allocation between two arms, normal approximation, and an effect to detect expressed as a fraction of the observed effect. Such assumptions do not change the actual single-group design. Any resulting sample-size figures are hypothetical planning illustrations, not observed power or a report of the study's sample-size justification. The trial's own sample-size justification is not reported in the registry record.

What is not specified about the analysis?

The record lists 26 outcome measures and 1 analysis, but does not describe the statistical methods used for the primary endpoint or the secondary measures. It does not report whether the primary analysis was adjusted, how missing observations were handled, how repeated observations were treated, or whether any interim analyses occurred. Those details are not reported in the registry record and should not be inferred from the endpoint's confidence-interval description.

In general, the choice of method should match the form of the outcome, its denominator, and the study design. Counts, proportions, and continuous measure scores require different summaries and assumptions. For count data, over-dispersion matters when variability exceeds what a chosen count model expects; a model that ignores it may give misleading standard errors. This is general statistical context, not a claim that a count model or an over-dispersion adjustment was used in SHARE-S.

For this record, the distinction between intended methods and reported findings is central. The 95% confidence interval is part of the endpoint description, not a numerical result. Without the estimate, interval, denominator, and analysis details, statistical precision and model assumptions cannot be independently evaluated.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("SHARE-S Intervention")
n      <- c(118)
events <- c(40)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  SHARE-S Intervention  118  40  33.9  25.4  43.2  26.0  42.8  26.0  42.8

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 26 outcome measures and 1 analysis. The primary endpoint is enrollment among electronically referred patients, while secondary outcomes include adoption, acceptability, appropriateness, feasibility, enrollment per month, retention, text-response adherence, and coaching-session adherence. The record does not report a multiplicity strategy, such as a hierarchy of hypotheses, an adjustment to significance thresholds, or a designation of which secondary outcomes were confirmatory. Such a strategy is not reported in the registry record.

In general, when several outcomes are examined, the chance of finding an apparently notable result by chance can increase if many tests are treated as equally confirmatory. A prespecified primary endpoint can help focus interpretation, but its presence alone does not reveal how secondary analyses were handled. Because numerical results and analysis details are absent, the impact of multiplicity cannot be assessed for this study.

Missing-data methods and analysis populations are also not described. The registry does not report whether all enrolled participants were included in each outcome, how incomplete questionnaires or missed coaching sessions were treated, or how unobserved outcomes were handled. The denominator and participant flow for the primary enrollment endpoint are not reported in the registry record. These omissions limit assessment of whether the outcome summaries, if available, would represent all participants or a subset.

In general, missingness can matter when participants with incomplete data differ from those with complete data. Interpretation depends on the amount, reasons, and handling of missing observations. None of those details should be assumed for SHARE-S.

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 adverse-event figures list an overall group of 40 at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. No top serious adverse-event terms are listed. These figures are descriptive registry entries; they do not provide event narratives, follow-up detail, or an explanation of how adverse events were collected and classified.

In general, a zero in a registry summary means that no events are recorded in that category for the reported group and data. It does not demonstrate that the underlying risk is zero, particularly when the group is limited in size or when details about observation and reporting are unavailable. The record does not report additional safety-analysis methods or the completeness of adverse-event ascertainment.

The serious adverse-event figures should be read separately from the implementation outcomes. They do not indicate whether the program was acceptable or feasible, and they do not provide a comparison of safety against another group. Since this was a single-group pilot, the record does not support a comparative safety estimate.

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

The study record describes a completed pilot of SHARE-S, an implementation program built around electronic referral, health coaching, and tailored text or email messages. It lists 40 participants enrolled and identifies enrollment after electronic referral as the primary endpoint. It also names a range of implementation outcomes, including acceptability, appropriateness, feasibility, retention, and adherence.

Those details describe the study's purpose and scope, but the record does not report a numerical primary endpoint result, its 95% confidence-interval limits, or numerical results for the secondary outcomes. It is therefore not possible to state how many referred patients enrolled or to characterize the enrollment estimate's precision. The overall enrollment figure should not be treated as the missing endpoint count or denominator.

The design does not include a control group. In general, a single-group study can document outcomes among participants in the implementation context, but it cannot establish how those outcomes compare with what would have occurred under another approach. The record does not support a causal conclusion about the program or a claim of comparative benefit.

The registry also does not provide enough detail to evaluate the analysis population, missing data, multiplicity, or the statistical methods used beyond the stated intention to use a 95% confidence interval for the primary endpoint. These omissions matter because a result's interpretation depends on who was counted, how the endpoint was defined, and how uncertainty was estimated.

The appropriate conclusion is limited: SHARE-S was studied as a pilot intended to test implementation and data-collection procedures, with enrollment and implementation outcomes identified for assessment. The record does not report the outcome values needed to judge the observed performance of the intervention. The absence of those numerical results is not evidence for or against any particular implementation outcome.

14. Why This Trial Matters Statistically

Implementation pilots address questions that differ from those of comparative efficacy trials. SHARE-S was designed to test study protocols, the implementation program, and mixed-methods data collection. Its intervention combined electronic referral with health coaching and tailored text or email messages, and its listed outcomes included adoption, acceptability, appropriateness, feasibility, retention, and adherence. These domains can help characterize whether an implementation approach can be studied and how participants engage with it.

The primary endpoint focuses on enrollment out of electronic referrals, a point in the pathway between identifying patients and their participation. In general, such measures can help researchers define recruitment processes and assess whether the denominator and follow-up procedures are workable. They are distinct from clinical outcomes and from a controlled estimate of treatment effect.

The study's single-group design is important to that interpretation. It can provide descriptive information about the pilot cohort, but it does not compare SHARE-S with a concurrent control condition. The record's 40 enrolled participants describe the study's listed enrollment; the missing primary outcome estimate prevents a quantitative reading of referral-to-enrollment performance.

Statistically, the record illustrates the difference between naming a method and reporting a result. A 95% confidence interval is specified for the primary endpoint, but its estimate and limits are not reported in the registry record. Without those values, the intended precision cannot be judged. Likewise, listing many implementation outcomes does not establish their observed levels or how multiplicity was addressed.

The pilot's contribution, as described in the record, is its focus on implementation processes and the planned measurement of several dimensions of participation. The registry entries support understanding the design and outcome framework, not evaluating numerical outcomes or making comparative claims.

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 most direct limitation for interpreting the posted results is that the primary endpoint's numerical estimate and 95% confidence-interval limits are not reported in the registry record. Although the endpoint is framed as enrollment out of electronically referred patients, the numerical numerator and denominator are also absent. The listed study enrollment of 40 does not resolve those missing quantities.

The single-group design has no concurrent control group, so it cannot provide a direct estimate of how enrollment or other outcomes compare with another condition. Allocation is listed as NA and masking as none. The record also does not report details of participant eligibility, recruitment flow, or the characteristics of those enrolled, limiting assessment of how the pilot cohort relates to the broader clinic population.

Although 26 outcome measures are listed, detailed numerical findings for the secondary outcomes are not included in the record details. Definitions and analysis methods for the measures are not reported. The record does not specify how missing data were handled, which participants were included in each analysis, or how multiple outcomes were considered. A statistical analysis plan, interim analyses, and the trial's own sample-size justification are not reported in the registry record.

Finally, the listed enrollment and safety summaries do not provide enough detail to assess referral completeness, outcome ascertainment, or adverse-event reporting. These limits mean that the study's implementation results and their precision cannot be fully evaluated from the registry information described.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Shared Healthcare Actions and Reflections Electronic Systems in Survivorship — NCT04337203.
• Registry record last updated 2023-06-28; status last verified 2023-06.
• Results first posted 2023-06-28.
• 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

NCT04337203 is a completed, single-group pilot of the SHARE-S Implementation Program, sponsored by Wake Forest University Health Sciences. The registry lists enrollment of 40, a start date of 2020-09-08, and a primary completion date of 2022-05-31. The program includes electronic referral, health coaching, and tailored text or email messages for patients referred to a cancer survivorship clinic.

The primary endpoint concerns the number of patients enrolled out of those electronically referred, with a stated 95% confidence interval and a timeframe of 1 year, 8 months. Numerical endpoint results and interval limits are not reported in the registry record. Listed secondary outcomes address implementation and adherence. The safety summary records 0 serious adverse events, 0 other adverse events, and 0 deaths among 40 at risk. The single-group design provides no control-group comparison.