Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance (NCT04101526), a non-randomized na study. The primary outcome is Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances.

2. Clinical Question

3. Trial Design

This completed study evaluated development and testing of a Spanish-language CBT-I intervention for cancer-related sleep disturbance. The registry identifies the study model as sequential, allocation as nonrandomized, and masking as none. It lists the phase as NA. These descriptors matter when interpreting comparisons: the intervention and waitlist arms should not be treated as if participants had been randomly assigned to otherwise equivalent groups.

The record describes pre-intervention qualitative interviews about sleep disturbance among breast cancer survivors and preferences for an intervention. Interviewees could include survivors, caregivers, cancer support group leaders, and clinicians. It also lists a videoconference-delivered Spanish-language CBT-I arm and a waitlist control group. Waitlist participants were to receive no intervention until 6 weeks after baseline, complete a follow-up assessment, and then be offered CBT-I.

The listed enrollment is 30. The study began on 2019-08-15, had a primary completion date of 2021-03-01, and is marked completed. The sponsor is H. Lee Moffitt Cancer Center and Research Institute. These registry entries describe study status and structure; they do not establish what participants experienced or what outcomes occurred.

The primary endpoint concerns recruitment-based acceptability, while the listed secondary outcomes concern efficacy using PSQI and ISI scoring. Although those outcome topics are named, outcome results and the methods used to analyze them are not reported in the registry record. The nonrandomized, sequential design also limits the interpretation of any apparent differences between arms: observed differences could reflect features of the groups or study sequence rather than the intervention alone.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 33 eligible candidates were approached for participation in the trial

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 Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances, measured over Baseline.

The primary endpoint is titled Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances. It measures recruitment as the percentage of patients enrolled, and the stated decision criterion is that the study is acceptable if at least 50% of eligible cancer survivors who are approached agree to participate. The endpoint timeframe is baseline, and its unit is participants.

Recruitment is relevant to an intervention-development study because willingness to join can indicate whether the approach is feasible to offer to the intended population. It is not a measure of change in sleep disturbance, symptom relief, or treatment efficacy. It addresses whether eligible people approached agreed to take part under the study’s conditions.

The registry reports that 33 eligible candidates were approached and lists enrollment as 30. It does not report a calculated recruitment percentage, clarify the endpoint numerator in a separate results entry, or state whether the prespecified acceptability criterion was met. Accordingly, the counts alone should not be converted into a recruitment rate in this interpretation. The PSQI and ISI efficacy outcomes are listed as secondary outcomes, but their results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a participant-count endpoint for recruitment-based acceptability. The underlying idea is a proportion: the number of eligible people who enroll is considered relative to the eligible people approached. A proportion is interpretable only when its numerator and denominator refer to clearly defined groups and the same recruitment process. Here, the record states that 33 eligible candidates were approached and lists enrollment as 30, but it does not report the calculated recruitment percentage or separately specify the endpoint numerator. The result should therefore be read as not reported in the registry record, rather than reconstructed from the counts.

What does the acceptability threshold mean?

The threshold is a prespecified decision rule in the registry description: the study would be deemed acceptable if at least 50% of eligible cancer survivors approached agreed to participate. Such a threshold turns a recruitment measure into a feasibility criterion. It does not describe treatment benefit, and meeting it would not by itself establish that the intervention reduces sleep disturbance. The registry does not report whether the criterion was met.

How should the study design affect comparisons?

Allocation is listed as nonrandomized, masking as none, and the model as sequential. In general, randomization helps make comparison groups similar on average with respect to measured and unmeasured characteristics. Without random allocation, group membership may be related to participant characteristics, timing, or other factors. Sequential conduct can also make the groups’ circumstances differ. The registry explicitly warns that the arms are not a like-for-like control comparison. Consequently, any contrast should be treated as descriptive unless stronger design and analysis information supports a causal interpretation.

Masking is listed as none. As a general statistical consideration, awareness of treatment assignment can affect participant reports, adherence, or outcome assessment, especially for outcomes based on reported symptoms. The registry does not describe who assessed outcomes or provide further detail about masking procedures.

What do the named sleep measures contribute?

The registry lists efficacy outcomes using PSQI and ISI scoring. These identify the intended outcome domains, but no scores, changes, comparison estimates, or uncertainty intervals are reported in the registry record. A statistical estimate describes the magnitude and direction of an observed association or difference. A confidence interval, as a general concept, expresses uncertainty around an estimate; it does not guarantee that the true value lies within the interval, and its interpretation depends on the study design and analysis. No confidence intervals or corresponding estimates are reported.

The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. These assumptions do not describe the trial’s own design justification. The registry does not report a protocol sample-size justification. Such illustrations are for planning, not observed power, and do not show that an effect was detected or that the study was adequately powered.

What can the safety counts establish?

Safety information is recorded as counts with group-specific numbers at risk. The listed groups each have 15 at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths recorded. As a general statistical point, event counts are descriptive and should be interpreted in light of the number observed, follow-up duration, event definitions, and completeness of reporting. The registry does not provide event narratives, exposure duration, or additional detail needed to assess rare or delayed events.

The record lists 5 outcome measures and 0 analyses. It does not state an inferential model, adjustment strategy, handling of repeated measurements, or method for uncertainty estimation. No calculation beyond the registry’s own reported statistics is warranted. In particular, the names of outcomes and the design assumptions do not substitute for posted estimates and their precision.

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("Eligible Cancer Survivors Who Were Approached Agre")
n      <- c(33)
events <- c(30)
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  Eligible Cancer Survivors Who Were Approached Agre  33  30  90.9  75.7  98.1  76.4  96.9  76.3  96.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 5 outcome measures, including the primary recruitment-based acceptability endpoint and secondary outcomes using PSQI and ISI scoring. It does not report a multiplicity strategy, such as which outcomes were designated confirmatory or whether significance levels would be adjusted across multiple analyses. The registry lists 0 analyses, and outcome-specific statistical results are not reported in the registry record. It is therefore not possible to determine how multiple outcomes were handled or to interpret a family of inferential tests.

Missing-data methods are not reported in the registry record. There is no description of how incomplete questionnaires, missed follow-up assessments, withdrawals, or unavailable outcome values were handled. The registry also does not report the amount or pattern of missing outcome data. Without that information, the completeness and potential representativeness of the reported outcome data cannot be evaluated.

Analysis populations are not described. The record does not say whether outcomes were analyzed among all enrolled participants, among those who began the intervention, among those who completed assessments, or using another defined population. These distinctions can affect interpretation, especially in a nonrandomized sequential study. The record also does not report an intention-to-treat approach or a per-protocol analysis.

These omissions do not establish that no such procedures were used; they mean that the procedures are not reported in the registry record. Interpretation should remain limited to the stated study design, endpoint definitions, and posted counts rather than assuming an unreported analysis plan.

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 registry’s safety entries show 0 serious adverse events, 0 other adverse events, and 0 deaths in the videoconference Spanish-language CBT-I group. For the waitlist control group, the corresponding recorded counts are also 0, 0, and 0. The number at risk is listed as 15 for each group. No serious adverse-event terms are listed.

These figures describe the events recorded in the registry for the listed groups. They do not establish that there was no possibility of harm, and they should not be interpreted as proof of safety. The registry does not report the duration or completeness of safety monitoring, event definitions, participant-level narratives, or whether events were actively solicited. It also does not provide further detail about the timing of safety observations.

Because allocation was nonrandomized and the study was sequential, the group counts do not constitute a randomized safety comparison. The registry’s caution that the arms are not a like-for-like control comparison applies to safety interpretation as well as efficacy interpretation. The posted counts are best read as descriptive reporting, not as an estimate of comparative risk.

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

The registry record establishes that the study was completed, used a sequential nonrandomized design without masking, and evaluated a Spanish-language CBT-I intervention delivered by videoconference. Its primary question was framed around recruitment: whether at least 50% of eligible cancer survivors approached agreed to participate. The record lists 33 eligible candidates approached and an enrollment of 30, but does not report the calculated recruitment rate or state whether the acceptability criterion was met.

The record also names PSQI and ISI scoring as secondary efficacy outcomes. It does not report outcome scores or comparative estimates. Therefore, the posted information does not establish whether sleep disturbance changed, whether the intervention differed from the waitlist, or how precisely any effect was estimated. No treatment benefit or lack of benefit can be concluded from outcome names alone.

Likewise, 0 recorded serious adverse events, 0 other adverse events, and 0 deaths in each group are descriptive counts. They are not proof that adverse events cannot occur. The information needed to assess follow-up duration, completeness of safety monitoring, and the precision of any safety estimate is not reported in the registry record.

As a general statistical principle, a study’s design determines how confidently observed differences can be attributed to an intervention. Here, nonrandom allocation and sequential conduct mean that a simple group contrast would be vulnerable to differences between groups beyond treatment. The registry itself cautions that the arms are not a like-for-like control comparison. The appropriate conclusion is therefore narrow: the registry reports the study structure, recruitment criterion, and specified safety counts, while the primary recruitment result and sleep-outcome results are not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically relevant because it separates feasibility from efficacy. Recruitment-based acceptability asks whether eligible people approached are willing to enroll under the study conditions. That is a different question from whether the intervention changes sleep disturbance. Keeping these questions distinct prevents a recruitment measure from being mistaken for a clinical outcome.

The study also illustrates why design labels matter. Nonrandom allocation and sequential conduct can create differences between intervention and waitlist groups that are not caused by treatment. The registry explicitly cautions that the arms are not a like-for-like control comparison. Recognizing that limitation is essential before interpreting any group contrast as an intervention effect.

The study’s focus on a Spanish-language intervention delivered by videoconference addresses how treatment might be offered to cancer survivors who have difficulty sleeping. The registry includes qualitative interview plans concerning sleep disturbance and preferences, with survivors and other stakeholders among the described interviewees. These components can inform intervention development, but the registry does not report interview findings or outcome results.

Finally, the record demonstrates the importance of complete results reporting. It names PSQI and ISI efficacy outcomes and gives a recruitment criterion, yet the calculated recruitment result and sleep-outcome estimates are not reported in the registry record. Without estimates and their uncertainty, readers cannot assess the magnitude or precision of the intended outcomes. The posted safety counts can be described, but they do not replace detailed monitoring information. Statistically, a careful account distinguishes what the registry reports from what remains unknown.

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 interpretation is that outcome results are not reported in the registry record. The recruitment endpoint is defined and the numbers approached and enrolled are listed, but the calculated recruitment rate and whether the stated acceptability criterion was met are not reported. PSQI and ISI are named as secondary efficacy outcomes, but no scores, changes, comparisons, or uncertainty estimates are reported.

The design is nonrandomized and sequential, with no masking. The registry explicitly states that the arms are not a like-for-like control comparison. This limits causal interpretation of any observed group differences. The registry does not describe the allocation process in further detail, the timing of intervention outcome assessments, or methods used to adjust for group differences.

Further limitations include the absence of reported analysis methods, missing-data procedures, analysis populations, multiplicity handling, and a protocol-based sample-size justification. The registry lists 0 analyses, but does not provide enough detail to determine whether analyses were conducted outside the posted record. The safety counts are also limited by the absence of reported monitoring duration, event definitions, and event narratives.

The record lists enrollment as 30, but does not provide detailed participant characteristics or clarify the representativeness of those enrolled. It describes pre-intervention qualitative interviews, but their findings are not reported. These gaps restrict assessment of generalizability, feasibility beyond the stated recruitment information, and the clinical interpretation of the intervention.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance — NCT04101526.
• Registry record last updated 2024-10-29; status last verified 2024-10.
• Results first posted 2024-10-29.
• 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

NCT04101526 is a completed study titled Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance. It was sponsored by H. Lee Moffitt Cancer Center and Research Institute, used a nonrandomized sequential design, and had no masking. The intervention was Spanish-language CBT-I delivered by videoconference; a waitlist control group was also listed. Enrollment is recorded as 30.

The primary endpoint concerned recruitment-based acceptability, with a stated criterion that at least 50% of eligible cancer survivors approached agree to participate. The record states that 33 eligible candidates were approached, but does not report the calculated recruitment rate or whether the criterion was met. Secondary outcomes using PSQI and ISI scoring are named, but their results are not reported in the registry record.

The listed group safety counts show 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. The record cautions that the nonrandomized arms are not a like-for-like control comparison. Detailed outcome analyses, missing-data methods, and analysis populations are not reported in the registry record.