Flatbush FHC Proactive Colorectal Cancer Screening and Navigation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Flatbush FHC Proactive Colorectal Cancer Screening and Navigation (NCT05646355), a randomized na study. The primary outcome is Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months.

2. Clinical Question

The trial is described as a randomized controlled pilot intended to assess the effectiveness and acceptability of proactive screening outreach among eligible patients. The posted primary outcome addresses screening completion through FIT, rather than completion of any colorectal cancer screening option. Although the outreach letter described both FIT and colonoscopy options, the primary outcome specifically counts initial FIT completion. A secondary outcome listed in the registry concerns participants with a positive FIT who complete colonoscopy at 6 months.

This distinction matters when interpreting the question. The primary result indicates how many participants were recorded as completing FIT in each arm; it does not describe all screening activity, the number choosing colonoscopy instead, or diagnoses. The registry record does not report a separate posted result for the secondary outcome. Nor does it give further details about acceptability measures, despite acceptability being part of the pilot’s stated purpose.

3. Trial Design

The registry identifies NCT05646355 as a completed, randomized, parallel-group pilot trial sponsored by NYU Langone Health. The study title is “Flatbush FHC Proactive Colorectal Cancer Screening and Navigation,” and the official title describes colorectal cancer screening through proactive outreach and navigation in a federally qualified health care center in Brooklyn. The study is listed as not applicable for phase. Its recorded enrollment is 109.

Participants were assigned to Proactive Screening Outreach or Usual Care. The trial is listed as having no masking. In the outreach arm, participants were to receive a clinic letter explaining FIT and colonoscopy options, a FIT kit, and instructions for completing and returning it. The letter also included information for navigation to screening colonoscopy, although the registry’s arm description is incomplete at that point. The Usual Care description says that individuals in this group would not be approached or notified of their enrollment.

The primary outcome is the number of participants completing an initial FIT by 6 months after the intervention began. The registry records an outcome timeframe of up to Month 6. The posted arm results report 50 participants in each group for this outcome: 7 completed FIT in Proactive Screening Outreach and 0 in Usual Care. The record also lists one secondary outcome: the number of participants with a positive FIT who complete colonoscopy at 6 months.

The study is marked completed. The recorded study start is 2023-03-15, and primary completion is recorded as 2023-12-11. Those dates describe the registry record and do not establish when each participant was followed or whether all participants had complete outcome data. The registry record does not report the randomization procedure, allocation concealment, a protocol-level analysis plan, or details of participant flow. It also does not explain why the outcome results include 50 participants per arm while total enrollment is recorded as 109.

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:

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 Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months, measured over Up to Month 6.

The primary endpoint counts participants who completed an initial fecal immunochemical test by 6 months after the intervention began. It is a count of participants, not a count of tests or a measure of test results. The record describes FIT completion as colorectal cancer screening via FIT by 6 months past the start of the intervention.

For this outreach study, the endpoint focuses on a concrete screening step that the intervention directly encouraged: participants could receive a FIT kit and completion and return instructions. Counting completion can therefore describe whether participants reached that step during the stated follow-up window. In general, a process endpoint can be useful for evaluating whether an outreach approach is associated with engagement in the intended process, without requiring the trial to measure a later clinical outcome.

The endpoint is narrower than overall screening completion. The outreach letter also discussed colonoscopy, but the primary outcome counts initial FIT completion specifically. The registry record does not state whether colonoscopy undertaken without a preceding FIT was included in this primary endpoint. It also does not report a primary endpoint definition for screening completed by other means.

The endpoint does not measure whether a participant had colorectal cancer, whether screening changed cancer incidence, or whether any health outcome changed. A separate secondary outcome concerns colonoscopy completion among participants with a positive FIT at 6 months, but a result for that outcome is not reported in the registry record. The primary count should therefore be interpreted as a record of FIT completion within the stated timeframe, not as a broader measure of screening or clinical benefit.

7. Results Posted in the Registry

• Proactive Screening Outreach: 14.0% (7/50) versus 0.0% (0/50) on control; risk difference 14.0 percentage points (95% CI 4.4 to 23.6); unadjusted two-proportion z-test p = 0.006.

8. Statistical Interpretation

9. Statistical Methods Explained

What is the outcome scale?

The primary outcome is binary at the participant level: a participant either completed the initial FIT by the specified follow-up time or did not. The posted arm results present counts of participants with the event. The comparison is a risk difference, which contrasts the event proportion in the outreach group with the event proportion in the usual-care group. A risk difference is expressed on an absolute proportion scale; it is not a relative risk or an odds ratio.

For a binary endpoint, the count of participants with an event is interpreted alongside the number of participants in the relevant group. The registry reports 7 events among 50 participants in the outreach arm and 0 among 50 in usual care. The comparison reports a risk difference of 0.14. These are the posted values; no additional effect measure is needed to describe the direction and scale of the contrast.

What does randomization contribute?

Random assignment is intended, in general, to make comparison groups similar on average with respect to factors present before assignment. It supports a causal interpretation when assignment and follow-up are carried out as planned and the analysis appropriately represents the randomized groups. The registry identifies the trial as randomized, but does not report the sequence-generation method, allocation concealment, or the analysis population. Those details are relevant to evaluating the strength of a causal interpretation and are not reported in the registry record.

The trial is listed as parallel and unmasked. A parallel design assigns participants to one of the study arms and follows those groups over the same general study period. No masking means that the study is not listed as masked; the registry does not provide further detail about who knew assignments or whether outcome assessment involved any separate procedures.

How should the p-value be read?

The posted p-value is 0.006 and is identified as unadjusted. In general, a p-value is calculated under a null hypothesis and a statistical model or test. It describes the compatibility of the observed data with that null model, conditional on the test’s assumptions. A smaller p-value is not a measure of effect magnitude, and it is not the probability that the null is correct. The registry record does not name the test, describe its assumptions, or give a full analysis plan, so the exact calculation cannot be independently assessed from the record.

Because the outcome is binary and the usual-care arm has no observed events, it is especially important not to infer an unstated modeling choice. Different statistical procedures can handle sparse event patterns differently. The posted estimate and p-value should be attributed to the registry comparison; no alternative test or adjusted result is reported.

What does the confidence interval add?

The reported 95% confidence interval for the risk difference runs from 0.044 to 0.236. In general, a confidence interval presents uncertainty around an estimated quantity under a specified procedure. It is not a guarantee that the true value lies within the particular interval, and it is not a range containing a fixed proportion of individual participant outcomes. The registry does not identify the interval method, so the assumptions and performance of that procedure cannot be evaluated.

What can planning illustrations tell readers?

Any sample-size illustrations associated with these results are planning illustrations based on the observed effect, not the trial’s original design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such calculations can show how a hypothetical future study’s size depends on the assumed effect and design settings. They do not establish that the trial had a particular probability of detecting an effect, and they are not observed power.

The registry record does not report a sample-size justification for the trial. The planning assumptions should therefore not be mistaken for the original protocol’s rationale or statistical plan. Because no numerical planning results are described in the record summary, no particular future sample size can be stated.

What is not specified?

The registry record does not report the primary analysis model, the confidence-interval method, handling of missing outcomes, a prespecified analysis population, covariate adjustment, or a multiplicity strategy. It also does not report interim analyses. The number of listed outcome measures is 3, while one secondary outcome is named in the record; the record does not explain the status or results of any other measures. These omissions do not change the posted primary figures, but they limit a complete statistical audit and make it important to distinguish the reported comparison from assumptions that are not documented.

10. Confidence Intervals and Precision

The primary risk-difference estimate is 0.14, with a reported 95% confidence interval from 0.044 to 0.236. The interval is entirely above zero. This conveys that, under the procedure used to construct the interval, the estimated contrast is positive across the reported interval. The registry record does not identify that procedure, so readers cannot assess its assumptions or compare its behavior with alternative methods for sparse binary data.

Precision concerns how narrowly an estimate is determined by the data and method. A confidence interval communicates uncertainty around the estimate, whereas the point estimate alone does not. The interval does not describe the range of individual responses, and it should not be read as a probability statement about the fixed underlying effect. In general, confidence intervals are interpreted in relation to the quantity estimated and the assumptions of the interval method.

The posted result is based on 50 participants in each arm for the primary outcome, even though total enrollment is recorded as 109. The registry record does not explain why these denominators differ or how that affects the analysis. The denominator issue is relevant to precision because the number of participants contributing outcome data is part of the information behind an estimate. Without a participant-flow account, the impact of any excluded or missing observations cannot be determined.

The absence of events in the Usual Care arm makes the comparison sparse. In general, sparse data can make estimates and interval methods more sensitive to the statistical procedure used. The record gives the interval limits and p-value but does not name the procedures, so precision should be understood from the posted interval without assuming a specific calculation method.

The interval describes uncertainty in the risk difference for FIT completion in this trial. It does not provide precision information for the secondary colonoscopy outcome or any unreported clinical outcome. Those results are not reported in the registry record.

11. Multiplicity, Missing Data and Analysis Populations

The record identifies 3 outcome measures and lists one secondary outcome: the number of participants with a positive FIT who complete colonoscopy at 6 months. It reports 0 analyses and does not provide a posted result for that secondary outcome. The record does not explain the other outcome measures or their status. It also does not describe a hierarchy of outcomes or a multiplicity adjustment.

In general, when a study examines multiple outcomes or multiple comparisons, the chance of at least one apparently unusual result can depend on how many analyses are considered and how they are selected. A prespecified analysis strategy can help readers distinguish primary confirmatory questions from exploratory ones. The registry record does not report such a strategy, so the unadjusted p-value of 0.006 should not be presented as adjusted for multiplicity. It is not possible to determine from the record whether any adjustment was planned or used elsewhere.

The record lists total enrollment of 109, while the primary outcome reports 50 participants per arm. It does not give a participant-flow diagram or explain whether those counts reflect the randomized population, an outcome-available population, or another analysis set. The reasons the reported denominators do not match total enrollment are not reported in the registry record.

Missing outcome data are not described. The record does not state whether any participants lacked a six-month FIT outcome, how missingness was handled, or whether participants were analyzed according to their assigned groups. It also does not report exclusions after randomization or details of adherence to the assigned outreach approach. These gaps make it difficult to assess the relationship between the enrolled population and the primary analysis.

The trial’s acceptability aim is mentioned in its brief summary, but an acceptability measure or result is not detailed in the posted outcomes described in the record. The named secondary outcome also has no posted result. Conclusions should consequently remain focused on the reported primary FIT-completion comparison rather than treating unreported outcomes as evidence for or against an effect.

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 adverse-event figures report zero serious adverse events and zero deaths in each group. For both Proactive Screening Outreach and Usual Care, 50 participants are listed as at risk for serious events and 50 as at risk for other events; the affected counts are zero in each category. No serious-event terms are listed.

These figures mean that the registry record reports no events in the categories shown for the listed groups and denominators. They do not establish that no events occurred outside the registry’s recorded categories or observation period. The record does not provide additional safety definitions, reporting procedures, follow-up details, or a narrative explaining how adverse events were collected.

In general, observing no events in a study does not prove that an event is impossible or that the underlying risk is zero. Safety interpretation depends on the size and follow-up of the population, event definitions, ascertainment, and completeness of reporting. The listed denominators are not a substitute for a detailed account of monitoring and exposure time.

The trial’s primary focus was FIT completion after outreach. The adverse-event figures do not answer whether the outreach affected screening uptake, and the screening result does not answer questions about safety. The registry reports zero affected participants in the listed categories, with the qualifications that the record does not further describe how those data were collected or analyzed.

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

The primary posted result shows a higher number of FIT completions in the Proactive Screening Outreach arm than in Usual Care during the stated follow-up period: 7 participants completed FIT in the outreach group and 0 in usual care, with 50 participants reported in each arm. The registry comparison reports a risk difference of 0.14, a 95% confidence interval from 0.044 to 0.236, and an unadjusted p-value of 0.006. Together, these statistics describe the observed difference and its uncertainty under the analysis used for the registry result.

The result does mean that the posted comparison favors the outreach arm for the measured outcome of initial FIT completion by 6 months. It does not by itself establish that outreach caused the difference. Randomization can support causal inference, but evaluating that inference also depends on the conduct of the trial, complete follow-up, and analysis choices. Important details about those matters are not reported in the registry record.

The result does not show that all types of colorectal cancer screening increased. The primary endpoint counts FIT completion specifically, whereas the intervention letter also described colonoscopy. The registry record does not report whether colonoscopy without a FIT was captured in the primary outcome. The listed secondary outcome concerns colonoscopy completion after a positive FIT, but its result is not reported.

The result also does not establish effects on cancer detection, cancer incidence, mortality, or other health outcomes. Those are different questions from whether participants completed FIT within the stated period. The trial’s brief summary mentions acceptability, but no acceptability result is reported among the outcomes described in the record.

Finally, the enrollment total of 109 and the primary outcome denominators of 50 per arm are not reconciled in the record. Until participant flow and missing-data handling are clear, the relationship between total enrollment and the analyzed outcome remains uncertain. The posted estimate should be understood as a result for the reported arm counts, not assumed to represent every enrolled participant.

14. Why This Trial Matters Statistically

This trial illustrates a common statistical distinction between an intervention’s intended activity and the endpoint used to evaluate it. Proactive outreach offered information about FIT and colonoscopy, but the primary outcome focused on completion of initial FIT by 6 months. That endpoint makes the study’s measured question specific: it concerns completion of a screening step, not every possible form of screening or a later clinical outcome.

The trial also shows why absolute effect measures can be useful. A risk difference expresses the contrast between groups on the same scale as the event proportions. The posted estimate of 0.14 is accompanied by a confidence interval, allowing readers to consider both the direction of the observed contrast and the uncertainty around its magnitude. The unadjusted p-value gives a separate measure tied to a null-model test, but does not replace the estimate and interval.

At the same time, interpretation depends on clear reporting. The record identifies randomization and a parallel design, but does not explain the randomization procedure, analysis population, missing-data approach, or method used for the reported interval and p-value. The total enrollment of 109 is also not reconciled with the 50 participants per arm shown for the primary outcome. These details affect readers’ ability to evaluate how the estimate relates to the full randomized population.

As a pilot trial, the study can contribute information about the observed screening-completion contrast and the feasibility of evaluating proactive outreach in this setting. The record does not provide a sample-size justification or detailed protocol analysis plan, so planning illustrations based on the observed effect should not be mistaken for the original design rationale. The statistical value of the result rests on keeping its scope clear: a specific endpoint, reported denominators, and stated uncertainty, with limitations where design and analysis details are not documented.

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.

Several trial-specific limitations in interpretation arise from what the registry record does not describe. Although the study is identified as randomized, the randomization method and allocation concealment are not reported. The trial is listed as unmasked, but the record does not explain who knew the assignments or how outcome ascertainment was conducted. Those details may matter when assessing how assignment and measurement were implemented.

The posted primary outcome results include 50 participants in each arm, while total enrollment is 109. The record does not explain the difference, give participant flow, or state whether the outcome denominator represents all randomized participants. It does not describe missing outcomes, exclusions, adherence, or the analysis population. As a result, the extent to which the posted comparison includes the full enrolled population cannot be determined from the record.

The primary endpoint is specifically initial FIT completion, although the outreach described more than one screening option. The registry does not say whether colonoscopy without a prior FIT was included in the primary outcome. The listed secondary outcome concerns colonoscopy completion after a positive FIT, but its result is not reported. Acceptability is part of the stated study purpose, but an acceptability result is not reported in the outcome information described.

The registry does not identify the test used for the p-value or the method used for the confidence interval. It does not report covariate adjustment, multiplicity handling, interim analyses, or the sample-size justification. These omissions prevent a full assessment of the statistical procedures and the intended analysis. The result is therefore most appropriately described using the posted estimate, interval, p-value, and arm counts, while avoiding claims about unreported analyses or outcomes.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Flatbush FHC Proactive Colorectal Cancer Screening and Navigation — NCT05646355.
• Registry record last updated 2024-12-27; status last verified 2024-12.
• Results first posted 2024-12-27.
• 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

NCT05646355 is a completed randomized, parallel-group pilot trial of proactive colorectal cancer screening outreach and navigation at the Flatbush Family Health Center in Brooklyn. The registry lists no masking and records enrollment of 109. Proactive Screening Outreach included a letter about FIT and colonoscopy, a FIT kit, completion and return instructions, and information about navigation to colonoscopy. Usual Care participants were not approached or notified of their enrollment.

The primary outcome was the number of participants completing initial FIT by 6 months. The posted results report 7 of 50 participants in the outreach arm and 0 of 50 in usual care. The risk difference is 0.14, with a 95% confidence interval from 0.044 to 0.236 and an unadjusted p-value of 0.006. The registry also lists a secondary outcome about colonoscopy completion after a positive FIT, but its result is not reported.

The record does not explain the difference between total enrollment and the primary outcome denominators, or provide details about missing data, analysis populations, or the statistical procedures used. The primary result concerns FIT completion only.