A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men (NCT06052202), a randomized na study. The primary outcome is Percentage of Participants Who Received a Colorectal Cancer Screening Test.

2. Clinical Question

The trial asks whether a smartphone-based program can change colorectal cancer screening behavior among African American men compared with educational information about colorectal cancer and screening. The primary outcome focuses on a concrete event—whether an electronic health record showed that a participant received a screening test during the study period—rather than on intentions or knowledge alone.

3. Trial Design

The registry record describes a randomized, single-masked, parallel-group trial. The listed phase is NA, and the recorded enrollment is 128. Participants were assigned to CRC mHealth or Control Education. The registry record does not identify who was masked, how the random sequence was generated, or whether assignment was concealed before enrollment.

The intervention was behavioral and smartphone-based. Its text messages included colorectal cancer information, with some links to videos intended to help men overcome obstacles to screening. The control condition provided colorectal cancer and screening information developed by the Centers for Disease Control. Both groups therefore received educational content, while the intervention added its specific smartphone program and video links.

Participants completed a baseline survey about screening history and beliefs concerning colorectal cancer and the medical system. A follow-up survey was planned 6 months after baseline, and medical records were reviewed at 6 months to verify screening. The primary outcome record gives 63 participants in the intervention group and 65 in the control group. For the three secondary outcomes with posted group statistics, each group has 47 participants; reasons for the differing outcome counts are not reported in the registry record.

The recorded study start was 2023-12-08, primary completion was 2025-05-01, and status is COMPLETED. The registry record does not report the trial's original sample-size justification, its detailed statistical analysis plan, or details of any interim analyses. The randomized design supports a comparison of assigned groups, but the record does not provide enough detail to assess every design and implementation choice.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants Who Received a Colorectal Cancer Screening Test, measured over Month 6.

The primary endpoint assesses whether each participant received a colorectal cancer screening test after beginning the study, with assessment at Month 6. The registry description specifies electronic health record verification: a value of 1 indicates a screening test was found, and a value of 0 indicates no screening test was found. The outcome is presented as the percentage of participants with a verified screening test, while the posted group values are counts.

This endpoint is useful for asking whether the intervention was associated with completed screening rather than only a stated intention, a belief, or knowledge measured in a survey. Verification through records provides a documented basis for classifying the outcome. It does not, by itself, establish how complete the records were, whether every screening performed could be found, or how missing records were handled; those details are not reported in the registry record.

The posted count was 2 in the CRC mHealth group and 2 in Control Education. The unadjusted recalculated risk difference is 0.001, with a 95% confidence interval from -0.059 to 0.061. These figures describe the observed comparison and its uncertainty; they do not establish that the groups are equivalent or that the intervention has no possible effect.

7. Results Posted in the Registry

• CRC mHealth Intervention: 3.2% (2/63) versus 3.1% (2/65) on control; risk difference 0.1 percentage points (95% CI -5.9 to 6.1), risk ratio 1.03 (0.15–7.10); unadjusted two-proportion z-test p = 0.975.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Perceived Severity of Colorectal Cancer at Month 6

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • CRC mHealth Intervention: mean 2.82 versus 2.59 on control; difference 0.23 (95% CI -0.05 to 0.51), standardized effect d = 0.33; z-test p = 0.106.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CRC mHealth Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Perceived Susceptibility to Colorectal Cancer at Month 6

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • CRC mHealth Intervention: mean 2.82 versus 2.59 on control; difference 0.23 (95% CI -0.05 to 0.51), standardized effect d = 0.33; z-test p = 0.106.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CRC mHealth Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Perceived Benefits to Colonoscopy at Month 6

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • CRC mHealth Intervention: mean 4.23 versus 4.11 on control; difference 0.12 (95% CI -0.09 to 0.33), standardized effect d = 0.23; z-test p = 0.268.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CRC mHealth Intervention and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes address perceptions about colorectal cancer, screening, and knowledge, rather than verified screening behavior. Among the secondary comparisons with posted numerical results, the intervention-group means are higher than the control-group means. The corresponding unadjusted intervals include zero, and the results do not provide a clear separation between groups. This broad pattern is compatible with the primary result in the limited sense that neither the behavioral endpoint nor the posted perception comparisons show a precise between-group difference.

The secondary measures may help describe possible responses to educational content, but they do not answer the same question as the primary endpoint. A change in perceived severity, susceptibility, or perceived benefits is not itself evidence that a participant completed screening. Conversely, the primary record-based outcome does not explain why a participant did or did not get screened. The measures are related conceptually, but one cannot be used as a substitute for another.

The registry record lists five secondary outcomes. Numerical results are posted for perceived severity, perceived susceptibility, and perceived benefits to colonoscopy. Results for perceived benefits to stool testing and colorectal cancer knowledge are not reported in the registry record. The listed outcome set is therefore not fully represented by posted numerical results.

Secondary comparisons carry less weight when many outcomes are examined without a reported plan for controlling multiplicity. General explanation: testing several outcomes increases the chance that at least one result appears unusual by chance, even if no true differences exist. The registry record does not report a multiplicity adjustment or a hierarchy specifying which secondary outcomes were confirmatory. Their p values are unadjusted, and these findings are best treated as exploratory rather than conclusive.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Perceived Severity of Colorectal Cancer at Month 6
• Perceived Susceptibility to Colorectal Cancer at Month 6
• Perceived Benefits to Colonoscopy at Month 6
• Perceived Benefits to Stool Test at Month 6
• Colorectal Cancer Knowledge at Month 6

9. Statistical Interpretation

10. Statistical Methods Explained

What does the risk difference describe?

For a binary outcome such as screening recorded or not recorded, a risk is the proportion of participants with the event in a group. The risk difference compares the intervention-group risk with the control-group risk by subtraction. A value near zero indicates similar observed risks; positive or negative values indicate the direction of the contrast according to the stated group order. Here, the recalculated risk difference is 0.001. Its confidence interval runs from -0.059 to 0.061.

General explanation: an absolute difference is often easier to understand as a group contrast than a relative measure because it describes the distance between the two outcome probabilities. It does not, however, eliminate uncertainty. The small event counts in this trial mean that the estimate can change considerably with only a few outcome classifications, and the interval reflects the limited precision of the comparison.

How do risk ratios and odds ratios differ?

The risk ratio compares the outcome risks between groups as a ratio. The posted risk ratio is 1.032, with a 95% confidence interval from 0.150 to 7.102. An odds ratio compares odds rather than risks; the posted odds ratio is 1.033, with a 95% confidence interval from 0.141 to 7.565. Both point estimates are close to 1, the value indicating no relative contrast, while both intervals are broad.

General explanation: risk ratios and odds ratios are relative measures, and an odds ratio is not the same quantity as a risk ratio. When outcomes are uncommon, an odds ratio may resemble a risk ratio, but the two measures remain distinct. Broad intervals mean the data do not pin down the relative effect precisely. For this outcome, the absolute risk difference and its interval give a direct complement to those relative estimates.

What does the p value say?

The unadjusted p value for the primary comparison is 0.975. General explanation: a p value describes how compatible the observed data, or data more extreme, are with a specified null model under its assumptions. It is not the probability that the null hypothesis is true, and it is not a measure of the probability that a treatment will succeed. A large p value does not prove there is no difference; it indicates that the observed data do not provide a strong basis for rejecting the null model in that test.

The registry record does not report a sponsor-conducted primary inferential analysis. The posted comparison is an unadjusted recalculation from group summaries. The unadjusted label matters because the estimate is not presented as adjusted for baseline characteristics or other covariates. No adjustment strategy is reported in the registry record.

How are the secondary outcomes analyzed?

The posted secondary outcomes are continuous scale measures summarized by group means and standard deviations. Their comparisons are mean differences. General explanation: a mean difference expresses how far apart the average scores are on the measurement scale; the standard deviation describes the spread of individual scores within a group. A confidence interval for a mean difference describes uncertainty about the estimated contrast, under the assumptions of the analysis.

For perceived severity and perceived susceptibility, the posted mean difference is 0.23, with a 95% confidence interval from -0.049 to 0.509 and an unadjusted p value of 0.106. For perceived benefits to colonoscopy, the mean difference is 0.12, with a 95% confidence interval from -0.092 to 0.332 and an unadjusted p value of 0.268. Both comparisons have intervals that include zero. The record does not report the scale ranges or the details of the statistical models, so the clinical or practical meaning of a scale-unit difference cannot be determined from these numbers alone.

The registry record reports standard deviations for the secondary outcomes. General explanation: variability matters because it affects how precisely a group mean and a mean difference can be estimated. A mean summarizes the center of a distribution, while the standard deviation describes dispersion around that center. These summaries do not show the full score distributions or how scores relate to participant characteristics.

What can and cannot be inferred?

Randomization is intended to make assigned groups comparable on average, including characteristics that were not measured, but the registry record does not report details of sequence generation or allocation concealment. The posted analyses do not establish whether the comparison followed an intention-to-treat approach, how missing outcome data were treated, or whether any prespecified adjustments were made. Those features are important to interpreting estimates and are not reported in the registry record.

The sample-size planning figures use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect set to a stated fraction of the observed effect. General explanation: these are planning illustrations, not estimates of the trial's achieved power. A design's power depends on assumptions about the effect and variability or event rate, among other features. The trial's original design assumptions are not reported in the registry record, so the planning illustrations should not be treated as evidence about how the trial was originally sized.

11. Confidence Intervals and Precision

The primary risk-difference estimate is 0.001, and its 95% confidence interval extends from -0.059 to 0.061. General explanation: a confidence interval expresses a range of values reasonably compatible with the data and the method's assumptions. It is not a guarantee that the true effect lies within the interval, and it does not assign probabilities to individual values after the data have been observed. The interval includes zero and extends to differences in either direction, so the estimate does not locate the underlying difference precisely.

The relative estimates are also imprecise. The risk ratio of 1.032 has a 95% confidence interval from 0.150 to 7.102, and the odds ratio of 1.033 has a 95% confidence interval from 0.141 to 7.565. The width of these intervals indicates substantial uncertainty about the relative comparison. With only 2 events in each group, the data contain limited information about the event rate and the between-group contrast.

The secondary confidence intervals also include zero: the mean difference of 0.23 for perceived severity and susceptibility has an interval from -0.049 to 0.509, while the mean difference of 0.12 for perceived benefits to colonoscopy has an interval from -0.092 to 0.332. These intervals indicate uncertainty about the direction and magnitude of the mean contrasts. The scale ranges and thresholds for meaningful changes are not reported in the registry record, limiting interpretation of their practical importance.

Precision is distinct from whether a result crosses a decision threshold. A narrow interval can still include effects of practical interest, and a wide interval can include both little difference and appreciable differences. The primary interval's breadth means the posted result should not be read as demonstrating equivalence. No equivalence margin is reported in the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for these binary and continuous outcomes; they are not total event counts. The registry record lists no time-to-event outcome for these calculations. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the specified effect under those assumptions, if that effect and the assumptions were correct. The 90% power column uses a higher target chance of detecting the same specified effect, and consequently calls for more participants per arm. These are planning illustrations, not observed power.

The rows for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect illustrate how the target effect size changes the projected sample requirement. Smaller effects are harder to distinguish from random variation and therefore require more participants. For the primary binary outcome, the projected figures are especially large because the observed difference is very close to zero. Those outputs should be read as consequences of the stated planning assumptions, not as a realistic recommendation for a future study or a reconstruction of the original protocol.

The trial's own original sample-size assumptions, target effect, and justification are not reported in the registry record. The planning figures therefore do not establish what assumptions investigators used when designing the completed trial.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.031; treatment proportion p₁ = 0.032; average p̄ = 0.031.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.2461 = 0.4823.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.2461 = 0.2071.
4. n = (0.4823 + 0.2071)² / (0.0010)² = 498,182.9, rounded up to 498,183 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.0307692307692308                          # control proportion
p1 <- 0.0317460317460317                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(6052202)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 498,183 (80% power), 666,926 (90% power)
 75% of observed effect: n per arm = 882,312 (80% power), 1,181,164 (90% power)
 50% of observed effect: n per arm = 1,977,666 (80% power), 2,647,533 (90% power)
power.prop.test: 498182.9 
Simulated power at n = 498,183 per arm: 0.803 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple outcomes, including the primary screening measure and secondary measures of perceived severity, susceptibility, perceived benefits, and knowledge. It lists five secondary outcomes, but results for only three are numerically posted. The record does not report whether the outcomes were ranked in a prespecified hierarchy, whether any were designated confirmatory, or whether multiplicity was addressed through an adjustment procedure.

General explanation: when many hypotheses are tested, the chance of obtaining at least one apparently notable result by chance increases. A prespecified multiplicity strategy can help control that risk, but no such strategy is reported in the registry record. The secondary p values are unadjusted, so they should not be interpreted as if only one outcome had been considered. The absence of a reported adjustment does not prove that none was used; it means the registry record does not document one.

The registry description says participants were to complete a follow-up survey at 6 months and that medical records would be reviewed at 6 months. It does not report the extent or reasons for missing data, whether records were unavailable for some participants, or how missing values were classified or handled. The primary outcome description assigns 0 when no screening test is found in the electronic record, but it does not clarify how unavailable or incomplete records were distinguished from a verified absence of screening.

The registry record also does not identify the analysis population, such as whether all randomized participants were included in each analysis, or whether an intention-to-treat principle was used. The primary groups have posted sample sizes of 63 and 65, while posted sample sizes for secondary outcomes are 47 in each group. Reasons for those denominators and any exclusions are not reported.

Detailed analysis choices are also not reported: these include any covariate adjustment, handling of protocol deviations, and the approach to repeated or correlated measurements. The record does not report a detailed analysis plan or interim analyses. These omissions limit assessment of whether the posted comparisons match a prespecified analysis and how robust they are to missingness or analytic choices.

15. 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 list 0 serious adverse events among 63 participants in CRC mHealth and 0 among 65 participants in Control Education. The figures also list 0 other adverse events in each group and 0 deaths in each group. No serious adverse-event terms are listed.

These figures describe the events recorded in the registry record; they do not establish that no adverse experiences occurred. The record does not report event definitions, the method or frequency of safety collection, the observation period for these summaries, or whether events were assessed for relatedness to the intervention. It also does not provide detailed information about completeness of reporting. A zero count in a posted summary should therefore be read as a count of events reported in that record, not as proof that the intervention or study procedures have no risks.

The comparison between groups is also limited by the absence of reported event details and by the small number of participants. These safety summaries should be kept distinct from the efficacy outcome: they do not indicate whether screening behavior differed between the groups.

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

The results show that the registry recorded 2 participants with an electronic-record-verified screening test in each randomized group. The recalculated unadjusted risk difference is 0.001, with a 95% confidence interval from -0.059 to 0.061. The estimate is close to zero, but its confidence interval is broad enough to include differences in either direction. The data therefore do not give a precise estimate of the contrast.

This result does not demonstrate that the two approaches are equivalent. Equivalence requires a prespecified margin defining what difference would be small enough to count as equivalent, together with an analysis designed for that question; no equivalence margin is reported in the registry record. Nor does a large p value prove that the intervention has no effect. It indicates that the observed data do not provide strong evidence against the no-difference model in the unadjusted comparison.

The outcome was verified through electronic health records, which is distinct from relying solely on survey responses. However, the registry record does not report how complete the records were or how missing records were handled. The interpretation is therefore limited to the recorded outcome data and the described verification process.

The secondary measures concern perceptions and knowledge. Their posted comparisons do not establish that those outcomes changed reliably between groups, and the registry record does not provide numerical results for all listed secondary outcomes. In addition, the record does not document multiplicity handling or the full analysis plan. These limitations matter when considering several outcomes together.

The results describe this randomized comparison among the enrolled participants. They do not establish what would happen in other settings or populations, and they do not explain the reasons for the observed event counts. The findings are a statistical summary of the registry record, not a clinical recommendation.

17. Why This Trial Matters Statistically

This trial illustrates the distinction between testing an educational intervention and measuring a behavioral endpoint. The intervention was designed to address screening barriers through smartphone messages and video links, while the primary outcome was a screening test found in electronic health records. That separation is important: perceptions and knowledge can be relevant intermediate outcomes, but the central question concerns whether screening was completed.

It also demonstrates why a point estimate should not be read without its uncertainty. The primary risk difference is close to zero, while the confidence interval extends across negative and positive values. A point estimate alone might suggest little separation, but it cannot establish that meaningful differences are excluded. The relative-effect intervals are likewise broad, reflecting limited information in the small number of recorded events.

The randomized parallel-group design gives a direct framework for comparing the two educational approaches. At the same time, interpretation depends on information about allocation, outcome completeness, the analysis population, and prespecified methods. Those details are not reported in the registry record. Registration can make outcomes and results accessible, but incomplete reporting of analytic choices leaves uncertainty about how the comparison was planned and conducted.

The secondary outcomes also show why multiplicity matters. Several related perceptions and knowledge measures are listed, yet only some have posted numerical results, and no adjustment strategy is reported. A pattern across outcomes can be informative descriptively, but it should not be treated as a set of independent confirmations.

For biostatistical interpretation, this record is a useful example of separating observed counts, recalculated estimates, uncertainty, and unreported design details. The statistical conclusion is constrained by the data and by what the registry record documents; it should not be stretched into a claim of equivalence or a definitive account of the intervention's effects.

18. 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 primary outcome has only 2 recorded screening events in each group. This provides limited information for estimating an absolute or relative difference, as reflected in the broad confidence intervals. The trial's total enrollment was 128, but a relatively small number of observed events can still leave the effect estimate imprecise.

The primary outcome relies on electronic health records. Although the registry description specifies that records were used to verify screening, it does not describe record coverage, procedures for linking records, or how unavailable records were handled. The rule that no test found in the record is coded as 0 may not distinguish a true absence of screening from incomplete documentation; the registry record does not clarify this issue.

The registry record does not report the details of random-sequence generation, allocation concealment, or who was masked. It also does not specify the analysis population, whether missing data were imputed, or whether the primary comparison was adjusted. These gaps make it harder to assess the risks of bias and the sensitivity of findings to analysis decisions.

Secondary outcome counts are smaller than the primary outcome counts, and reasons for the differing denominators are not reported. Numerical results are absent for two listed secondary outcomes. Scale ranges and meaningful-change thresholds are also not reported, limiting interpretation of the scale differences beyond their statistical summaries.

Finally, the original sample-size justification, detailed statistical plan, and any multiplicity strategy are not reported. The registry's planning illustrations are based on observed effects and do not fill in the original design rationale. These record-specific limitations constrain what can be inferred from the posted results.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men — NCT06052202.
• Registry record last updated 2026-01-02; status last verified 2025-12.
• Results first posted 2026-01-02.
• 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.

22. Record Summary

The registry record describes a completed randomized, single-masked, parallel-group trial of a smartphone-based colorectal cancer screening program for African American men. The recorded enrollment is 128. CRC mHealth was compared with CDC-developed educational information, and the primary outcome was electronic-record-verified screening at Month 6.

The primary group counts were 2 in each arm. The recalculated unadjusted risk difference was 0.001, with a 95% confidence interval from -0.059 to 0.061 and an unadjusted p value of 0.975. The interval indicates substantial uncertainty about the size and direction of the difference. Secondary results were posted for three outcomes, while numerical results for two listed secondary outcomes are not reported in the registry record. The record does not report the full analysis plan, missing-data methods, original sample-size justification, or multiplicity strategy.