This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening (NCT06389981), a na na study. The primary outcome is Lung Cancer Screening Uptake.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06389981 |
| Phase | NA |
| Condition | Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Black Veterans who self-identify as eligible for lung cancer screening are the intended population for the Vet Peer Connects program. The registry describes a pilot intended to reach up to 40 eligible Veterans. Actual enrollment was 3; further participant characteristics are not reported in the registry record.
Intervention
The intervention is a peer-led community outreach program. The planned activities include community lung cancer screening orientations and tailored one-to-one support, such as coaching, goal-setting, and navigation to Veterans Affairs screening. The registry describes co-design as part of developing the program.
Comparator
There is no registered comparison group. The study is listed as a single-group study with allocation recorded as NA, so it does not compare participants receiving the program with a like-for-like control group.
Primary question
The primary outcome is the count of enrolled participants who undergo low-dose chest CT for lung cancer screening between enrollment and 3 months post-enrollment. The registry record does not report the observed count for this outcome.
The clinical question is therefore exploratory: can a peer-led, community-based program be developed and pilot tested with Black Veterans, and can screening uptake and other program outcomes be assessed? The registry describes planned work on feasibility and acceptability, including observations, activity logs, check-ins, and interviews with Veterans, community partners, and clinical staff. It also describes surveys of Social Cognitive Theory constructs and extraction of screening uptake and tobacco treatment information. These are elements of the study plan as described in the registry, not reported findings.
The distinction between the intended reach and actual enrollment matters. The program was described as aiming to reach up to 40 eligible Veterans, while the study enrollment recorded in the registry is 3. The record does not explain this difference or report how many group orientations or one-to-one support sessions were delivered. It also does not provide enough information to characterize the enrolled participants beyond the eligibility description. The primary question can be identified, but its answer cannot be determined from the posted results because an outcome count is not reported.
3. Trial Design
The registry classifies this study as a single-group pilot with no masking and no randomized allocation. Its status is completed, and enrollment is recorded as 3. The study is listed as phase NA. The sponsor is the VA Office of Research and Development. Its registered dates are a start date of 2025-02-01 and a primary completion date of 2025-06-28.
The intervention is described as the Veterans peer connect Program, a peer-led program intended for Black Veterans eligible for lung cancer screening. The broader study description includes co-design of a Veteran-centered intervention and a feasibility pilot. Planned program delivery includes up to 5 group orientations at community partner sites and tailored one-to-one support for up to 15 Veterans. The intervention arm description states that the program would be pilot tested by enrolling up to 40 eligible Black Veterans. These are planned maximums in the description; the registry reports enrollment of 3 and does not report delivered activity counts.
A single-group design can describe program delivery and outcomes among participants who enrolled, but it does not directly estimate what would have happened to similar participants without the program. With no registered control group, changes observed over time cannot be separated from other explanations using a between-group comparison. This limits causal interpretation, even if outcome data were available.
The registry lists 12 outcome measures and identifies the primary measure as lung cancer screening uptake. It names secondary outcomes concerning tobacco cessation treatment, smoking-related stigma, perceived peer support, screening knowledge and fatalism, trust in VA, and lung cancer and general cancer self-efficacy. The registry record does not report outcome estimates, statistical analyses, or results for these measures. It also does not report whether the planned co-design and pilot activities were completed as described. The study's completed status indicates the registry status, not that each planned activity or analysis can be verified from the posted results.
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
| Stage | Peer Led Intervention |
|---|---|
| STARTED | 3 |
| COMPLETED | 0 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Peer Led Intervention |
|---|---|
| Lost to Follow-up | 3 |
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.
| Characteristic | Unit | Peer Led Intervention |
|---|---|---|
| Participants analysed | 3 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Lung Cancer Screening Uptake, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is lung cancer screening uptake, expressed as a count of participants. The registry defines it through electronic health record review: whether low-dose chest CT for lung cancer screening occurred between study enrollment and 3 months post-enrollment. This is a participant-level, binary event summarized as a count. The registry does not report the observed count or the number with and without screening.
Using a clinical record to identify completed screening can provide an objective measure of whether the specified service occurred during the follow-up window. It differs from an intention or stated plan to seek screening: the endpoint concerns a documented screening event. The registry describes the outcome as a preliminary measure of program results alongside other planned data collection. In a feasibility pilot, such an outcome can help describe whether uptake was observed among enrolled participants and can inform later study planning. It cannot, by itself, show that the program caused any screening event, especially in a single-group design without a control group.
The endpoint's interpretation depends on the completeness and timing of the record review, as well as the definition of screening used. The registry specifies electronic health record review and a period extending from enrollment through 3 months post-enrollment, but it does not report details such as how missing or incomplete records were handled. The number enrolled is 3, but the screening outcome for those participants is not reported in the registry record. As a result, no estimate of uptake, uncertainty interval, or comparison with another group can be described from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record supports a limited description of the study's design and enrollment, but it does not report the primary outcome result. Enrollment was 3 in a completed, single-group pilot. The primary outcome was defined as a count of participants with low-dose chest CT screening from enrollment through 3 months post-enrollment. Without the observed count, the central uptake question remains unanswered by the posted results. No estimate of the proportion screened, precision interval, or test of a hypothesis is reported.
The intervention was designed as peer-led outreach for Black Veterans eligible for lung cancer screening, with co-design and feasibility testing described in the study summary. The program description includes community orientations and individual support. These details explain what the intervention was intended to involve; they do not establish how much intervention was delivered or whether participants found it feasible or acceptable. Those findings are not reported in the registry record.
The single-group design shapes what any reported outcome could mean. A count of screening events among enrolled participants would describe what occurred in the group, but without a control group it would not establish what screening uptake would have been in the absence of the program. Other influences on screening could also be present. This design is consistent with descriptive pilot work, while causal effectiveness requires a comparison capable of addressing alternative explanations.
The small recorded enrollment also means that any participant-level outcome would be based on very limited information. In general, small samples yield imprecise estimates, and a single participant's outcome can have substantial influence on a group summary. The registry record does not report a confidence interval or other uncertainty measure for uptake. This is not evidence that the intervention had no effect or that it had an effect; the outcome itself is not posted.
The record names several secondary outcomes, including tobacco cessation treatment and measures related to stigma, peer support, screening knowledge, fatalism, trust, and self-efficacy. It does not report results for these outcomes. Nor does it describe any statistical analysis: the number of analyses reported is 0. Consequently, no direction, magnitude, statistical significance, or precision can be inferred for the primary or secondary outcomes from the registry information.
The difference between the intended reach of up to 40 eligible Veterans and actual enrollment of 3 is relevant to interpreting the pilot's reach, but the record does not explain the difference. It does not report recruitment, retention, intervention exposure, or reasons for non-enrollment. Those omissions prevent a detailed assessment of recruitment feasibility and program delivery. The appropriate reading is therefore descriptive: the registry records a completed pilot with 3 enrolled participants, a defined screening-uptake endpoint, and no posted outcome analysis.
9. Statistical Methods Explained
The registered study is a single-group pilot, not a randomized comparison. Allocation is recorded as NA, and masking is listed as none. These design features matter because they determine what comparisons are available. The record describes one peer-led intervention group and no like-for-like control group. Accordingly, the study can describe outcomes among enrolled participants, but the registry design does not provide a concurrent comparison for estimating what would have happened without the program.
What does a count endpoint represent?
The primary endpoint is defined as a count of participants who experienced a specified event: low-dose chest CT for lung cancer screening during the period from enrollment to 3 months post-enrollment. In general, a binary participant outcome records whether each person did or did not experience the event, and a count adds together the participants with the event. The registry identifies the endpoint's unit as participants. It does not post the event count or the corresponding count without the event, so the endpoint cannot be summarized beyond its definition.
A count is not itself a measure of precision. A confidence interval, in general, expresses uncertainty around an estimate, with wider intervals indicating less precision and narrower intervals indicating more precision under the method used. No confidence interval or other uncertainty estimate for screening uptake is reported in the registry record. Without the outcome count and an uncertainty estimate, the posted information does not support a quantitative assessment of how precisely uptake was estimated.
Why does the design constrain inference?
In general, a control group helps distinguish outcomes associated with an intervention from outcomes that might have occurred for other reasons. In a single-group study, a screening event after enrollment is observed among participants who received or were offered the program, but there is no registered comparison group to provide a counterfactual benchmark. Changes over time can also reflect factors other than the intervention. Therefore, even if the primary outcome count were posted, it would be descriptive evidence from this pilot rather than a controlled estimate of program effect.
The registry calls the study a feasibility pilot and describes co-design and preliminary outcome collection. Such work can help assess whether a program can be delivered and can identify measures for later evaluation. The record describes a subsequent multi-site stepped-wedge trial as future work that this study is intended to inform. The registry does not report feasibility results or the design details of that future study.
What do statistical tests and planning assumptions mean?
General statistical interpretation distinguishes an estimate from a test. An estimate describes the outcome's magnitude; a test evaluates compatibility with a specified null hypothesis under stated assumptions. A p-value, when used, is calculated under a model and does not measure the probability that a treatment works. The registry reports no analyses, p-values, or statistical plan for the outcome results. Thus there is no inferential test to interpret.
The registry includes generic sample-size planning assumptions: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect described as a stated fraction of the observed effect. These are planning assumptions, not reported results from the pilot and not evidence of observed power. They describe a two-arm planning framework, whereas the registered study is single-group with allocation recorded as NA. The registry does not report a numerical sample-size calculation, a sample-size justification for this pilot, or a protocol explanation reconciling these planning assumptions with the registered design. No sample-size estimate should be read as an observed result.
In general, over-dispersion refers to variability in count data greater than a chosen statistical model expects. It can make standard errors too small if a model does not account for that extra variability. The primary outcome is a participant count, but the registry does not report a model, dispersion estimate, or analysis from which over-dispersion could be assessed. This general concept therefore does not imply that over-dispersion was present or that a particular method was used.
What does the analysis record tell readers?
The registry lists 12 outcome measures and reports 0 analyses. These figures describe the posted record; they do not establish whether analyses were conducted outside the registry. The record does not specify an analysis population, model, handling of missing data, or method for calculating uncertainty. It also does not report an interim analysis plan. These details should not be inferred from the outcome definitions or the study's completed status.
The named secondary outcomes span service use and psychosocial constructs. In general, multiple outcomes create a multiplicity issue when many statistical tests are interpreted together: the chance of finding at least one apparently unusual result can increase when tests are conducted without accounting for the number of comparisons. The registry does not report a multiplicity strategy or results for those measures. This is a reporting gap, not evidence that a particular adjustment was or was not applied outside the registry.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, identifies lung cancer screening uptake as the primary outcome, and names secondary outcomes related to tobacco cessation treatment, smoking-related stigma, perceived peer support, screening knowledge and fatalism, trust in VA, and cancer self-efficacy. The registry does not report the remaining outcome titles in the available record. It reports 0 analyses and does not provide statistical results for the primary or secondary outcomes.
When multiple outcomes are tested, multiplicity can make isolated findings harder to interpret. In general, if many hypotheses are assessed, some results may appear notable by chance alone. A prespecified hierarchy or adjustment method can help clarify interpretation, but the registry does not report a multiplicity plan. It is not possible to determine from the record whether any such plan existed outside it, or whether analyses were conducted but not posted.
Missing-data methods are also not reported in the registry record. The primary outcome is defined through electronic health record review, but the record does not say how unavailable records, incomplete follow-up, or uncertain screening status were handled. It does not report missingness for the surveys or other measures described in the study summary. No imputation method, complete-case approach, or sensitivity analysis is specified. These omissions mean that the effect of missing information on outcome estimates cannot be assessed.
The analysis population is not reported. The registry does not specify whether analyses were intended to include all enrolled participants, only participants with available outcome records, or another group. With no outcome results and no posted analysis description, it is not possible to identify a denominator for any outcome estimate or assess exclusions. The listed enrollment of 3 should not automatically be treated as the denominator for every measure.
These reporting gaps should be kept distinct from findings. They do not show that data were missing, that analyses were not performed, or that multiplicity was mishandled; they mean that these details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Peer Led Intervention | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Peer Led Intervention | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Peer Led Intervention | 0 of 3 |
The registry safety figures are for the Peer Led Intervention group. Serious adverse events were reported for 0 participants among 3 at risk. Other adverse events were reported for 0 participants among 3 at risk, and deaths were 0. The record lists no top serious adverse-event terms.
These figures are counts, not evidence that risk was absent. The number at risk is 3, so the safety experience captured in the registry is limited to a small enrolled group. In general, observing no events in a small group does not rule out events that could occur in a larger population or during different follow-up. The registry does not report additional detail about the safety-monitoring process, event ascertainment, or duration of safety follow-up.
The primary endpoint is screening uptake, not a safety endpoint. The safety counts should therefore be interpreted separately from the unanswered uptake question. No conclusion about effectiveness or overall safety can be drawn from these counts alone. The registry record reports the stated counts but does not provide a more detailed safety analysis.
12. What the Result Does, and Does Not, Mean
The posted information establishes that the registry describes a completed, single-group pilot of peer-led community outreach for Black Veterans eligible for lung cancer screening. Enrollment was 3. The primary endpoint was defined as whether a participant received low-dose chest CT screening between enrollment and 3 months post-enrollment. The registry does not report the observed result for that endpoint.
The result therefore does not establish how many participants underwent screening, what proportion did so, or how uncertain any uptake estimate would be. It also does not establish whether the program changed screening behavior. Even if a count were available, the absence of a registered comparison group would prevent a direct controlled comparison and would limit causal claims.
The study description sets out a program-development and feasibility purpose. It outlines peer-led group orientations, individual support, participant surveys, clinical record review, and interviews with Veterans, community partners, and clinical staff. These descriptions document intended activities and planned measures. The registry does not report how many activities took place, whether the intervention was acceptable, or what participants and partners said.
The registry lists secondary outcomes, but does not post their results or report statistical analyses. Consequently, no conclusion can be drawn from the record about tobacco cessation treatment, smoking-related stigma, peer support, screening knowledge, fatalism, trust, or self-efficacy. The safety counts report no serious adverse events, other adverse events, or deaths among the 3 participants at risk, but such counts in a small pilot do not establish the absence of risk.
The study's intended reach was up to 40 eligible Black Veterans, while recorded enrollment was 3. The registry does not explain this difference, so it cannot establish why enrollment was limited or whether the program would be feasible at a larger scale. The information is best read as a description of the registered pilot and its posted counts, not as evidence that the intervention does or does not improve screening uptake.
13. Why This Trial Matters Statistically
This pilot is statistically important as an example of the distinction between developing an intervention and estimating its effectiveness. The registry describes co-design of a peer-led program intended to address the needs of Black Veterans, followed by feasibility testing. These activities can inform how a later evaluation defines the intervention, recruits participants, measures uptake, and collects implementation information. The record describes this pilot as informing a subsequent multi-site stepped-wedge trial, but it does not report results from that later work.
The primary endpoint is concrete: a low-dose chest CT recorded between enrollment and 3 months post-enrollment. Defining a participant-level event in this way makes clear what the outcome is intended to capture. However, a clearly defined endpoint is not the same as a reported outcome. With no uptake count or analysis in the registry record, readers cannot assess the size or precision of any observed screening uptake.
The design also illustrates why an observed outcome and an intervention effect are different quantities. A single-group count would describe participants in the pilot. A controlled comparison would be needed to assess whether outcomes differ from what might have occurred without the program, subject to the assumptions of that comparison. The registry has no control group, so its design is suited to descriptive pilot aims rather than a direct causal estimate.
Finally, the gap between intended reach and recorded enrollment underscores the value of transparent reporting on recruitment and delivery in feasibility work. The record gives the intended maximum reach and actual enrollment but does not explain the difference or report implementation outcomes. Those details would help readers judge whether a larger evaluation can be planned and how its methods should be designed. The statistical lesson is to separate a program's rationale and planned measures from the outcome evidence actually reported.
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 most consequential limitation for interpreting outcomes is that the registry record does not report the primary screening-uptake result or analyses for any outcome. Although enrollment is recorded as 3 and the endpoint is defined, there is no outcome count, estimate, or uncertainty measure to interpret. The completed status does not fill this reporting gap.
The single-group design has no registered control group. It therefore cannot by itself distinguish outcomes associated with the peer-led program from outcomes that might have occurred for other reasons. This restricts causal interpretation independently of the small enrollment. The study is described as a feasibility pilot, which is relevant context, but the registry does not report feasibility findings.
Recorded enrollment of 3 is below the intended reach of up to 40 eligible Black Veterans described for the program. The record does not state why enrollment was 3, how participants were recruited, whether participants were retained through follow-up, or how much of the intervention they received. These omissions limit assessment of recruitment, reach, and implementation.
The registry does not report participant characteristics beyond the intended eligibility description, and does not provide analysis populations, missing-data handling, or outcome-specific denominators. It also does not give statistical methods for the outcome analyses, a sample-size justification for the pilot, or an explanation of the generic two-arm sample-size planning assumptions alongside the registered single-group design. Multiplicity handling and interim-analysis plans are not reported.
The safety record lists zero serious adverse events, zero other adverse events, and zero deaths among 3 at risk. The small group and lack of detail about event ascertainment constrain what these counts can establish. These are limitations of what can be interpreted from the registry record; they should not be mistaken for evidence that unreported procedures or analyses did not occur.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening — NCT06389981.
- Registry record last updated 2026-08-11; status last verified 2026-07.
- Results first posted 2026-08-11.
- 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.
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18. Record Summary
The registry describes NCT06389981, titled “Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening.” The sponsor is the VA Office of Research and Development. The study is listed as completed, with enrollment of 3, a start date of 2025-02-01, and a primary completion date of 2025-06-28. Phase is NA.
The design is single-group, with allocation recorded as NA and masking listed as none. The intervention is the Veterans peer connect Program, a peer-led outreach program for Black Veterans eligible for lung cancer screening. The primary outcome is a participant count for low-dose chest CT screening from enrollment through 3 months post-enrollment.
The registry lists 12 outcome measures and 0 analyses. It does not report the primary outcome result, secondary outcome results, or a statistical analysis. Safety counts are 0 serious adverse events among 3 at risk, 0 other adverse events among 3 at risk, and 0 deaths. The record describes co-design and a feasibility pilot intended to inform later research, but the posted information does not establish program effectiveness or explain the difference between intended reach and actual enrollment.