Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy (NCT05034289), a na na study. The primary outcome is Acceptability of Intervention.

2. Clinical Question

The study’s stated purpose was to develop an educational website to empower Black and African American cancer patients to make informed decisions about personalized cancer treatment and clinical trials. Its primary endpoint addresses whether participants found the intervention acceptable; it is not a direct measure of whether the tool changed treatment decisions, improved cancer outcomes, or reduced racial disparities.

The registry also lists secondary outcomes concerning knowledge about precision oncology and clinical trials, decision self-efficacy for tumor genomic sequencing and targeted or immune therapy, and patient empowerment. The record does not report results for those measures. As a result, the registered question can be described, but the posted record does not establish how acceptable participants found the tool or whether the other intended outcomes changed.

3. Trial Design

The registry identifies this as a completed, single-group study with no masking. Allocation is listed as not applicable, and the study is not described as a randomized comparison. The PINPOINT Digital Educational Tool is the behavioral intervention. Participants were asked to use the prototype before a clinic visit or immediately before an appointment with their treating oncologist.

The study combined qualitative development work with pilot testing. The brief summary states that qualitative interviews continued until saturation was achieved, with a target of 48 interviews. It also states a goal of 33 participants for the pilot trial and an overall target sample size of 81 for the study. These are targets described in the registry summary; the record does not establish that every target was reached or describe the final analysis population for each outcome.

The primary measure was collected immediately following completion of the intervention during the pilot testing session. The registry describes the intervention and exit survey as completed within approximately 30-40 minutes total on the same day. The stated primary endpoint population includes participants who completed both baseline and post-intervention surveys and remained eligible.

The registry lists 7 outcome measures and 5 analyses. The detailed statistical analysis plan, the specific models used for each outcome, and the handling of multiple outcomes are not reported in the registry record. The study is marked completed, with a listed start date of 2021-07-12 and primary completion date of 2023-05-19. Those dates describe the registry record; they do not supply the missing outcome estimates.

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.

Before assignment: A total of 81 participants were enrolled across two phases of the study. In the Key Informant Interview Phase, 48 participants enrolled and completed their interviews. In the Pilot Intervention Phase, 33 participants enrolled. Of these, 30 were analyzed.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants who completed both baseline and post-intervention surveys and remained eligible.

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.

Population: All randomized participants who completed follow-up.

6. Primary Endpoint

The registry lists the primary outcome as Acceptability of Intervention, measured over Immediately following completion of the PINPOINT intervention during the pilot testing session (same day; intervention and exit survey completed within approximately 30-40 minutes total)..

The primary endpoint is acceptability of the intervention, assessed with the 4-item Acceptability of Intervention Measure (AIM). The registry describes a score ranging from 1 to 5, with higher values indicating greater acceptability, and reports Cronbach's α = .85 for the measure. The endpoint is recorded as a mean with standard deviation, so its intended summary concerns the average score and the spread of scores among eligible participants.

Acceptability is relevant in a pilot because an educational tool must be usable and acceptable to its intended audience if it is to be considered for further evaluation. This is a general design rationale; acceptability alone does not establish that the tool improves knowledge, changes decisions, or affects health outcomes. The registry lists those broader topics among secondary outcomes, but their results are not reported in the registry record.

The endpoint was assessed immediately after participants completed the intervention during the pilot testing session. That timing captures an immediate response to the tool, rather than evidence about longer-term use or effects. The registry record does not report the observed mean, standard deviation, number of participants included in the primary endpoint analysis, or a confidence interval. Consequently, the measurement method and intended interpretation can be described, but the level of acceptability observed in the study cannot be determined from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary endpoint as a mean of a continuous measure, reported with a standard deviation. A mean represents the average score in the analysis population. A standard deviation describes how spread out individual scores are around that average. These are general statistical interpretations. In this study, the measure is the 4-item AIM score, ranging from 1 to 5, with higher scores indicating greater acceptability.

What does a mean score tell the reader?

A mean condenses responses into one summary value. It can be useful when the goal is to describe the overall response on a scale, but it does not show the full pattern of individual answers. Two groups of respondents could have the same mean while having different distributions of scores. A mean should therefore be read with its measure definition and a description of variability. The registry identifies standard deviation as the dispersion measure, but does not report the observed mean or standard deviation.

The AIM includes 4 items. The registry reports Cronbach's α = .85. In general, Cronbach’s alpha is an index of internal consistency: it describes how closely related items are within a scale in a particular dataset. It is not a measure of the scale’s accuracy for every purpose, nor does it show that the intervention itself is effective. The registry does not describe further measurement validation or give item-level results.

Why does the analysis population matter?

The primary endpoint population is defined as participants who completed both baseline and post-intervention surveys and remained eligible. This definition makes the analysis population narrower than everyone who might have been approached or enrolled if some participants did not meet those conditions. General statistical reasoning indicates that excluding participants with incomplete measurements can affect the result if the missingness is related to their responses or characteristics. The registry record does not report the number of participants in the endpoint analysis or a method for handling missing data.

The study is identified as single-group, with no masking and allocation listed as not applicable. In general, a single-group pilot can provide descriptive information about participants’ experience after an intervention. Without a concurrent comparator, it cannot isolate the intervention’s effect from other explanations for observed responses. The registry does not report a randomized design or a controlled comparison, so results should not be interpreted as a randomized treatment effect.

What can be inferred from the analysis plan?

The registry lists 7 outcome measures and 5 analyses, but does not report the statistical methods used for each analysis. In general, analyzing multiple outcomes or conducting multiple tests raises a multiplicity question: the more statistical tests considered, the greater the chance that at least one may appear noteworthy by chance if each is interpreted separately. Researchers may prespecify a primary outcome, adjust for multiple testing, or treat secondary analyses as exploratory. The registry record does not state whether any multiplicity adjustment was planned or used.

The record includes a sample-size planning description based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It also distinguishes participants per arm for most planning illustrations from total events for time-to-event illustrations. These are planning assumptions, not a description of this single-group study’s observed findings. The registry record does not report numerical sample-size illustrations for this trial, the protocol’s sample-size justification, or an observed-power calculation. Sample-size illustrations are not observed power.

In general, a confidence interval is an uncertainty summary around an estimate, with its width reflecting both variability and the amount of information available under the analysis assumptions. A narrow interval indicates more precision than a wide interval, but neither guarantees that the estimate is unbiased or clinically meaningful. No confidence interval is reported for the AIM score in the registry record. No p-value or inferential test for the primary endpoint is reported either.

Over-dispersion is a general concern when data vary more than a chosen statistical model expects. If it is ignored in a model that assumes less variability, uncertainty estimates can be too small. The primary endpoint is described as a continuous score summarized by a mean and standard deviation, and no model details that would allow assessment of over-dispersion are reported. It would be inappropriate to assume that a particular model or adjustment was used.

Finally, the brief summary says that qualitative interviews continued until saturation was achieved. In general, saturation is a qualitative research concept referring to the point at which additional interviews are no longer yielding meaningfully new themes under the study’s approach. It is distinct from statistical power and does not supply a quantitative outcome estimate. The record does not provide the qualitative analysis procedure or interview findings.

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("PINPOINT Digital Education Tool (Pilot Test)")
n   <- c(30)
m   <- c(4.11)
sp  <- c(0.54)
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  PINPOINT Digital Education Tool (Pilot Test)  30  4.110  0.540  3.908  4.312

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures and 5 analyses. The primary endpoint is acceptability; other listed outcomes concern knowledge, decision self-efficacy, and empowerment. When several outcomes are examined, multiplicity matters because interpreting many tests independently can increase the chance of highlighting a result that arose by chance. This is a general statistical consideration, not a claim about the study’s actual analysis. The registry record does not report whether testing was adjusted for multiplicity, how secondary outcomes were prioritized, or whether analyses were exploratory.

The primary endpoint population is described as participants who completed both baseline and post-intervention surveys and remained eligible. The registry record does not report the number included in that analysis, the amount or pattern of missing data, or the method used to handle missing values. It also does not state whether participants with incomplete questionnaires could contribute partial scale scores. Without these details, readers cannot assess how missingness may have affected the reported estimate; in this case, the estimate itself is not reported either.

The record’s outcome definitions and stated population do not establish a full analysis plan. Details such as a prespecified analysis population for each secondary measure, covariate adjustment, sensitivity analyses, or rules for incomplete data are not reported in the registry record. No assumptions about those procedures should be made.

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 reports serious adverse event counts of 0 in each listed group: Key Informant Patients, Key Informant Relatives, Key Informant Providers, and the PINPOINT Digital Education Tool (Pilot Test). It also reports other adverse event counts of 0 and deaths of 0 for each of those groups. The corresponding at-risk counts are listed as 20, 15, 13, and 33, respectively. These figures are descriptive counts in the registry record.

Zero reported events in these groups means that the registry lists no events in the specified categories for the listed groups. It does not prove that risk is absent, and it does not establish that a larger or longer study would have the same observations. In general, event counts are interpreted in light of the number of people observed, duration of follow-up, event definitions, and completeness of reporting. The registry record does not provide additional event descriptions or follow-up details that would support a broader safety assessment.

The registry lists no top serious adverse event terms. The figures should be read as safety reporting for this study, not as a comparative safety result: the design does not include a separate control group, and no risk comparison is reported.

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

The registry record describes a study designed to develop and pilot PINPOINT, a digital educational tool for Black and African American cancer patients considering personalized cancer treatment and clinical trials. It identifies acceptability as the primary endpoint and specifies how that outcome was measured. The record does not report the observed AIM score, so it does not show how acceptable participants found the tool.

Even with a reported acceptability estimate, the endpoint would have a specific scope. It would describe participants’ immediate responses after using the tool during pilot testing. It would not, on its own, demonstrate improved knowledge, stronger decision self-efficacy, changes in treatment choices, improved health outcomes, or reduced racial disparities. Those are broader questions, and the registry lists some related secondary measures but does not report their results.

The design is single-group and does not include a reported comparator. Consequently, it cannot support a direct treatment-versus-control estimate. A single-group study may provide useful descriptive information about how an intervention is received, but it cannot distinguish intervention effects from other influences on responses. No causal claim about the tool’s effect follows from the design description alone.

The study’s purpose—to develop an educational resource intended to empower Black and African American patients—is distinct from evidence that the resource achieved that purpose. The registry record documents the intent, the intervention, the outcome definitions, and the study status. It does not report the numerical results needed to judge the primary endpoint, the uncertainty around that endpoint, or the results for the listed secondary outcomes.

The appropriate interpretation is therefore limited: the registry documents a completed pilot study and its planned measurement of acceptability, but the posted results do not permit an assessment of the observed acceptability level or the intervention’s broader effects.

14. Why This Trial Matters Statistically

This trial is statistically notable for the distinction between an intervention’s development goals and the outcomes that can be evaluated from a registry record. PINPOINT was intended to support informed decisions about personalized cancer treatment and clinical trials among Black and African American cancer patients. Its primary endpoint, however, is acceptability, a more immediate measure of participants’ response to the tool. Keeping those questions separate prevents an acceptability measure from being mistaken for evidence of clinical or equity impact.

The single-group design also defines what can be learned. It can be used to describe participants’ experience of the intervention, but there is no reported randomized comparator for estimating a contrast. That distinction is important when interpreting pilot research: feasibility and acceptability questions may be appropriate early objectives, while causal questions generally require a design that supports comparison.

Another statistical issue is transparency about outcome estimates. The registry provides the measure definition, scale direction, timing, analysis population, and intended summary statistic, but not the primary score or its uncertainty. This means readers can understand what the study aimed to measure without being able to evaluate the result. Complete reporting of estimates and uncertainty is needed for an informed statistical interpretation.

The study also includes several secondary outcomes and analyses. Their presence makes clear why readers need information about analysis plans, missing data, and multiplicity. Those details are not reported in the registry record. The trial therefore illustrates how design, measurement, analysis, and reporting each shape the conclusions that can responsibly be drawn.

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.

A central limitation of the available record is that the primary outcome estimate is not reported. The AIM score’s mean and standard deviation are absent, as are a confidence interval and a primary-outcome test. As a result, the study’s central acceptability finding cannot be quantified or assessed for precision from the registry record.

The study is single-group, with no reported control condition. This limits the scope of any inference: there is no like-for-like comparison to separate the intervention’s contribution from other influences. The registry record also does not report a pre-intervention acceptability score, so the primary endpoint cannot be interpreted as a documented change in acceptability.

The registry identifies the primary analysis population by survey completion and eligibility, but does not report how many participants were included in that analysis or how missing data were handled. It does not provide the results for the listed secondary measures, the qualitative findings, or enough detail to evaluate the analysis methods. Multiplicity procedures, if any, are not reported in the registry record.

The record describes targets for qualitative interviews and pilot testing, but does not establish from the outcome information whether those targets were reached in each analysis. Its stated endpoint timing captures an immediate response; longer-term use or effects are not reported. Finally, the record’s zero adverse event counts are descriptive and do not provide a comparative safety assessment.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Promoting INformed Approaches in Precision Oncology and ImmuNoTherapy — NCT05034289.
• Registry record last updated 2026-05-18; status last verified 2026-04.
• Results first posted 2026-05-18.
• 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

NCT05034289 is a completed, single-group study of the PINPOINT Digital Educational Tool, a behavioral intervention developed to support informed decisions about personalized cancer treatment and clinical trials. The registry describes an intended population of newly diagnosed Black cancer patients and a primary endpoint of acceptability measured with the 4-item AIM. Scores range from 1 to 5, with higher scores indicating greater acceptability, and the measure is summarized as a mean with standard deviation.

The registry summary states a target of 48 qualitative interviews, a goal of 33 participants for the pilot, and an overall target sample size of 81. It also lists 7 outcome measures and 5 analyses. The record marks the study completed, but does not report the primary acceptability score, its variability, or results for the listed secondary outcomes. The design has no reported comparator, and analysis details concerning missing data and multiplicity are not reported in the registry record.