Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator (NCT04268979), a randomized na study. The primary outcome is Family Caregiver Well-Being Using GAD-7 Scale.

2. Clinical Question

The study is randomized and parallel-group, but the registry record does not report the allocation ratio or the number assigned to each arm. Its stated purpose concerns caregiver burden, while the named primary measure captures anxiety symptoms. These are related but not interchangeable concepts: the GAD-7 score describes anxiety symptoms, not burden in all its dimensions. Without outcome values, the record cannot establish the direction or size of any difference between the assigned conditions.

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. Its listed enrollment is 296, and its status is completed. The study start date is 2020-02-13, and the primary completion date is 2024-07-03. The sponsor is H. Lee Moffitt Cancer Center and Research Institute. The registry lists the phase as NA.

The intervention arm is named eSNAP & Caregiver Navigator. Its description refers to the eSNAP intervention plus questionnaires. The other arm is a waitlist control condition: participants in that condition were to complete questionnaires during the 8-week study period and then have access to eSNAP, including questionnaires and 8 weeks of Caregiver Navigator sessions as needed. The timing of access means that the assigned conditions differ during the initial study period; the registry record does not report follow-up comparisons after waitlist participants gained access.

Randomization can help balance measured and unmeasured characteristics between groups on average, but it does not guarantee balance in a particular trial. The absence of masking is relevant because participants knew their assigned condition. The registry does not report whether outcome assessors or analysts were masked, so their masking status is not reported in the registry record. The method used to generate or conceal the random allocation is also not reported in the registry record.

The primary outcome timeframe is 8 weeks per participant. The record lists six outcome measures, but does not provide results or analysis details for them. It reports zero analyses. The number assigned, treated, retained, and included in each outcome analysis is not reported in the registry record. Consequently, the listed enrollment should not be treated as the number contributing to the primary outcome analysis, and it cannot be used to infer group-specific sample sizes.

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

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 Family Caregiver Well-Being Using GAD-7 Scale, measured over 8 weeks per participant.

The primary endpoint is family caregiver well-being measured using the Generalized Anxiety Disorder 7 Item Scale, or GAD-7, at 8 weeks per participant. The outcome is described as a mean score, with standard deviation as its measure of dispersion. The record explains that each item is scored from 0-3 points and that the total score ranges from 0-21; a higher score means more anxiety.

The GAD-7 gives a structured way to summarize anxiety symptoms. In general, a standardized questionnaire can make outcomes comparable across participants and can help researchers assess whether symptom scores differ between study conditions. Here, the registry uses the score as a measure of caregiver well-being, but the scale specifically measures anxiety. It does not, by itself, represent every aspect of well-being or caregiver burden.

The registry record does not report the mean or standard deviation for either arm, a between-arm estimate, or uncertainty around a comparison. It also does not report the instrument’s administration details, such as who completed it or how incomplete questionnaires were handled. Accordingly, the endpoint is defined, but its observed values and the degree of precision of any comparison are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group design without masking. In general, randomization assigns participants to study conditions using a chance process. This can reduce systematic differences between groups at assignment, although chance imbalances can still occur. A parallel-group design compares assigned conditions over the same study period rather than having each participant receive both conditions in sequence. Here, the named conditions are eSNAP plus Caregiver Navigator and a waitlist control condition.

What does the primary measure summarize?

The primary outcome is a continuous score: the GAD-7 mean at 8 weeks per participant. A continuous measure can take values across a scale rather than representing only categories such as yes or no. The registry describes scoring from 0-3 points per item, a total range of 0-21, and a higher score as indicating more anxiety. The mean summarizes the central score for a group; the standard deviation describes variation in scores around that mean. Reporting both can help readers understand the average and the spread, but neither group’s values are reported in the registry record.

How would a group comparison be interpreted?

In general, a comparison of group means estimates the difference in average outcome between assigned conditions. Its interpretation depends on the analysis population, observed data, and assumptions of the method. A confidence interval communicates statistical uncertainty around an estimate; it is not a guarantee that the true effect lies within the interval. A p value, when used, quantifies how incompatible the data are with a specified null model under the analysis assumptions. It does not measure the size or importance of an effect. The registry record reports no mean comparison, confidence interval, or p value for the primary outcome, and the statistical analysis plan is not reported in the registry record.

What do the planning assumptions mean?

The record describes a sample-size planning illustration using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. These are stated assumptions for an illustration, not a description of the actual allocation or a reported analysis. The illustration is said to use a stated fraction of the observed effect. The observed effect and the numerical planning outputs are not reported in the registry record. Such calculations answer a planning question about the sample size associated with assumed conditions; they are not observed power and cannot show whether the completed trial found a difference.

In general, a normal approximation uses a mathematical approximation to describe the sampling distribution of an estimate. Whether it is suitable depends on the outcome, sample information, and analysis details. The registry record does not report the exact statistical test or model used for the primary endpoint, so it is not possible to assess the model’s assumptions or how the recorded planning approximation relates to the final analysis.

What is not available for assessing the analysis?

The record reports six outcome measures and zero analyses. It does not report primary-outcome means, standard deviations, a comparison estimate, or uncertainty. It also does not report an analysis population, the number of participants contributing outcome data, or how missing scores were handled. These omissions matter because a reported enrollment is not necessarily the same as the number included in a particular analysis. In general, missing outcome data can affect the interpretation of a group comparison if participants with missing scores differ from those with observed scores. The extent and handling of missingness are not reported in the registry record.

The record also does not report whether the primary analysis adjusted for baseline scores or other participant characteristics, whether it followed randomized assignment, or whether any interim analyses were planned or performed. The statistical plan, including any multiplicity procedure, is not reported in the registry record. These details should not be inferred from the randomized design or from the outcome description. Without them and without a posted outcome analysis, the statistical properties and robustness of a primary comparison cannot be evaluated.

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("Family Caregivers")
n   <- c(94)
m   <- c(8.95)
sp  <- c(6.08)
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  Family Caregivers  94  8.950  6.080  7.705  10.195

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and zero analyses. The primary outcome is identified as caregiver well-being using the GAD-7, but results for that measure are not reported. The other outcome measures and their results are not described in the available record details. A multiplicity plan—such as whether the primary outcome was designated before analysis or how multiple outcomes or comparisons were handled—is not reported in the registry record.

In general, testing multiple outcomes or comparisons can increase the chance of finding at least one apparently notable result by chance. Statistical methods can address that issue, but the appropriate approach depends on the questions and analysis plan. No adjustment method or testing hierarchy is reported, so it is not possible to determine how multiplicity was considered.

Missing-data handling is also not reported in the registry record. The number of participants with an observed GAD-7 score at 8 weeks, the number with missing scores, reasons for missingness, and any method used to address missing data are not reported. In general, missingness can affect an estimate if the availability of a score is related to the outcome or assigned condition. The analysis population is not reported either: the record does not specify whether the primary analysis included everyone as randomized, only participants with observed scores, or another defined group.

These gaps prevent assessment of how completely the analysis retained the randomized comparison, how missing outcomes may have influenced the result, and how the family of outcome tests was interpreted. No assumptions about those methods can be made from the record.

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

The record establishes that this completed randomized study was designed to compare eSNAP plus a Caregiver Navigator with a waitlist condition for family caregivers of neuro-oncology patients. It specifies caregiver anxiety measured by the GAD-7 at 8 weeks per participant as the primary endpoint. It does not report the primary outcome results or any analysis. As a result, the record does not establish whether the groups differed in GAD-7 scores, how large any difference was, or how precisely it was estimated.

The registry’s stated purpose concerns caregiver burden, while the primary endpoint captures anxiety symptoms. General statistical interpretation should keep those constructs distinct. A GAD-7 result would speak to scores on that measure; it would not, by itself, answer every question about caregiver burden or well-being. The registry description also does not report a separate burden outcome result.

Randomization is relevant to how a between-group comparison could be interpreted, but a design description is not a result. Without outcome values, an estimate and its uncertainty, and analysis details, it is not possible to determine whether an observed contrast was compatible with no difference or with a range of other possibilities. Completion status and listed enrollment do not fill that gap.

These limitations do not demonstrate that the intervention had no effect, nor do they demonstrate that it had an effect. They indicate that the registry record does not report evidence that would support either conclusion. The record is informative about the intended comparison, intervention timing, endpoint, and study status; it is not sufficient to evaluate the primary outcome result or its statistical reliability.

13. Why This Trial Matters Statistically

This study raises a practical statistical question: how should a behavioral support program be evaluated when its stated aim concerns caregiver burden but its primary measure is an anxiety symptom scale? Keeping the construct and the instrument distinct is important. A score can provide structured information about a defined symptom domain without capturing every dimension of caregiver experience.

The randomized, parallel-group design is relevant because it sets up a comparison between an intervention condition and a waitlist condition during the 8-week study period. The waitlist arrangement also means that the comparison described in the record concerns a particular period before the waitlist group received access. The record does not report a later comparative analysis after that access began.

Statistically, the endpoint definition alone is not enough to judge evidence. Readers need group summaries and an estimate of the between-condition contrast, together with uncertainty and information about the analysis population and missing outcomes. Those results are not reported in the registry record. The listed enrollment of 296 and completed status cannot replace those elements, and a planning illustration cannot serve as an observed treatment comparison.

The case therefore illustrates the distinction between a trial’s design and its posted evidence. A registered primary question can be clear even when its statistical answer is unavailable in the record. Reporting the estimate, its precision, and the analysis choices would be needed to assess what the trial’s data say about the specified endpoint.

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 trial-specific limitation for interpretation is that the registry record reports zero analyses and does not provide primary outcome results. There are no posted GAD-7 group means or standard deviations, no between-arm estimate, and no measure of uncertainty. The result’s direction, magnitude, and precision therefore cannot be assessed.

The record lists enrollment as 296 but does not report the number assigned to each arm or the number contributing data to the primary endpoint. It does not describe participant characteristics, eligibility criteria, adherence, intervention exposure, or retention. The extent to which enrolled participants received the intended intervention is not reported in the registry record.

The primary endpoint is specified as a GAD-7 score, while the study purpose refers to caregiver burden. The registry does not report a separate analysis linking the anxiety measure to burden, and the two concepts should not be treated as identical. The outcome administration details and handling of incomplete questionnaires are also not reported in the registry record.

The record describes the study as unmasked, but does not say whether outcome assessors or analysts were masked. Randomization and allocation procedures, analysis populations, missing-data methods, multiplicity handling, and the statistical analysis plan are not reported in the registry record. These gaps limit assessment of the conduct and robustness of any comparison; no such comparison is posted in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator — NCT04268979.
• Registry record last updated 2026-02-20; status last verified 2026-02.
• Results first posted 2025-10-14.
• 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

NCT04268979 is a completed randomized, unmasked, parallel-group study sponsored by H. Lee Moffitt Cancer Center and Research Institute. The registry lists enrollment of 296, a start date of 2020-02-13, and a primary completion date of 2024-07-03. The condition is brain cancer.

The study compares eSNAP plus a Caregiver Navigator with a waitlist control condition. The waitlist description specifies questionnaires during the 8-week study period, followed by access to eSNAP and 8 weeks of Caregiver Navigator sessions as needed. The primary outcome is mean GAD-7 score at 8 weeks per participant, with standard deviation as the dispersion measure. The scale is described as ranging from 0-21, with higher scores indicating more anxiety.

The registry lists six outcome measures and zero analyses. Primary outcome results, analysis details, and participant counts by arm are not reported in the registry record. Therefore, the record describes the planned comparison and endpoint but does not report the statistical result.