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 Rural Interventions for Screening Effectiveness (NCT02795104), a randomized na study. The primary outcome is Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02795104 |
| Phase | NA |
| Condition | Breast, Cervical or Colorectal Cancer Screening Needed |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 985 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Rural women identified as needing breast, cervical or colorectal cancer screening. The registry record describes the condition as a need for one or more of these screening services; further eligibility details are not reported in the registry record.
Intervention
A tailored interactive DVD, either on its own or combined with telephone-based patient navigation. In the DVD-only arm, participants watched the program and answered its questions. In the navigation arm, participants watched the DVD and were called by a patient navigator.
Comparator
Usual care consisted of brochures explaining cancer screening and offering information and encouragement. The three approaches were assigned in parallel randomized arms; the registry lists no masking.
Primary question
Across the three randomized arms, what proportion of participants received all screening they needed, and what proportion received any screening they needed, during follow-up of up to 12 months?
The trial asks whether screening adherence differs among these approaches. It considers two related outcomes: completion of all needed screening and receipt of any needed screening. These are not interchangeable definitions. Someone could receive some, but not all, of the screening considered necessary; the registry’s title identifies both outcomes, but the posted record does not give their separate results.
The interventions address screening information and support, with navigation added to one of the DVD approaches. The comparison therefore concerns assigned intervention strategies, not just the content of a single educational message. The registry record does not report enough detail to define eligibility beyond the stated screening need, or to establish how that need was assessed for each participant.
3. Trial Design
The study is titled “Rural Interventions for Screening Effectiveness” and is registered as NCT02795104. It is a completed, randomized, parallel-group trial with no masking. The listed enrollment is 985. The registry identifies the phase as not applicable. The record lists a start in 2016-11 and primary completion in 2020-07.
Three behavioral interventions were compared. One group received a tailored interactive DVD and answered questions presented in the program. A second received the DVD plus telephone contact from a patient navigator. The usual-care group received brochures containing screening information and encouragement. The record describes the arms, but does not report the randomization sequence method, allocation concealment, or the intended allocation ratio.
The primary outcome timeframe was up to 12 months. The stated outcome concerns the percentage of participants who received all needed screening and any needed screening across the randomized arms. The registry describes an initial plan for pairwise chi-square tests, followed by binary logistic regression comparisons, with adjustment for selected baseline demographic covariates. It also describes multiple imputation as a sensitivity analysis for adherence outcomes.
The primary completion date and completed status indicate that the trial’s registry record is marked complete; they do not establish that every planned analysis was performed or reported. Although the registry lists cost-effectiveness and intervention cost as secondary outcomes, their results are not reported in the registry record. The sponsor is Ohio State University Comprehensive Cancer Center. Further details of recruitment, intervention delivery, adherence to assigned interventions, and follow-up procedures are not reported in the registry record.
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 | Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) | Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) | Arm III Usual Care (UC) |
|---|---|---|---|
| STARTED | 389 | 395 | 201 |
| COMPLETED | 382 | 388 | 193 |
| NOT COMPLETED | 7 | 7 | 8 |
Reasons for not completing this period:
| Reason | Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) | Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) | Arm III Usual Care (UC) |
|---|---|---|---|
| Determined to be Ineligible with Exit Data | 7 | 5 | 7 |
| Withdrawal by Subject | 0 | 2 | 0 |
| Lost to Follow-up | 0 | 0 | 1 |
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 | ARM I (TIDVD) | ARM II (TIDVD, PN) | ARM III (UC) | Total |
|---|---|---|---|---|---|
| Participants analysed | 382 | 388 | 193 | 963 | |
| Age, Customized: Age at consent | years | 58.2 (SD 6.4) | 58.8 (SD 6.3) | 58.8 (SD 6.3) | 58.6 (SD 6.3) |
| Sex/Gender, Customized: Female | Participants | 382 | 388 | 193 | 963 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 1 | 3 | 5 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 2 | 0 | 3 |
| Race (NIH/OMB): White | Participants | 376 | 375 | 185 | 936 |
| Race (NIH/OMB): More than one race | Participants | 3 | 6 | 3 | 12 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 3 | 1 | 5 |
| Region of Enrollment: United States – Indiana | Participants | 159 | 149 | 70 | 378 |
| Region of Enrollment: United States – Ohio | Participants | 223 | 239 | 123 | 585 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms, measured over Up to 12 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint concerns screening adherence, expressed in the registry title as the percentage of participants receiving all needed screening and any needed screening. The measure is defined for participants and covers follow-up up to 12 months. It is binary at the participant level: a participant either meets a specified adherence definition or does not. The registry describes the endpoint parameter as a count of participants, while the title expresses the result as a percentage.
The two adherence definitions capture different levels of completion. “Any needed screening” asks whether a participant received at least some screening that was needed. “All needed screening” asks whether the participant received the full set considered necessary. A study can report both because partial completion may be meaningful as a separate description of screening behavior. The registry record does not give the operational rules for determining which tests each participant needed or how tests completed during follow-up were verified.
In general, a binary adherence endpoint allows comparison of the fraction meeting a defined criterion across randomized groups. It is relevant to this trial because the interventions were intended to support screening, and the stated outcome measures screening receipt rather than knowledge alone. However, a registry description of an endpoint is not a result. The registry record does not report participant counts or percentages meeting either definition, nor estimates of differences between arms. Consequently, the size and precision of any intervention comparison cannot be evaluated from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and describes how screening adherence was intended to be assessed. It does not report the primary outcome values. In particular, it gives no arm-specific counts or percentages for participants receiving all needed screening or any needed screening, and no effect estimates, confidence intervals, or p-values for those outcomes. The direction and magnitude of the primary comparisons are therefore not reported in the registry record.
This absence matters for interpretation. A description of planned tests cannot establish whether groups differed, how large a difference might have been, or how compatible the data were with a range of possible effects. Without estimates and uncertainty measures, there is no basis in this registry record for judging precision or for distinguishing a small, uncertain contrast from a larger, more precisely estimated one. No conclusion about the effectiveness of any approach follows from the intervention descriptions alone.
The record says that pairwise chi-square tests would be used initially and that binary logistic regression would compare the interventions with usual care while adjusting for selected covariates. These are descriptions of intended analyses; the record does not show the resulting test statistics or regression estimates. It also does not state whether the described analyses were completed as planned. The reported enrollment and the adverse-event populations do not substitute for outcome denominators, which are not reported for the primary endpoint.
In general, a confidence interval communicates the uncertainty around an estimated effect, including values that remain reasonably compatible with the observed data under the analysis. A p-value addresses compatibility with a specified null model; it does not measure the size or practical importance of an effect. Neither can be interpreted for the primary endpoint without reported results. The registry record also does not report the covariate-specific balance findings that would indicate which demographic factors met its stated baseline screening rule.
The trial’s completed status should be read as a registry status, not as evidence that results are available in this record. The record lists cost and cost-effectiveness as secondary outcomes but contains no reported results for them. Overall, the registry supports a description of the study question and planned analysis approach, while leaving the main empirical findings and their precision not reported in the registry record.
9. Statistical Methods Explained
The registry describes an analysis plan for a binary adherence outcome, but does not report analysis results. The methods below explain the stated approach in general terms and distinguish that explanation from what can be confirmed about this trial.
Why use a chi-square test?
The record says the outcome would initially be tested with pairwise chi-square tests. In general, a chi-square test compares observed counts across categories with the counts expected under a no-association model. For a binary outcome such as meeting or not meeting an adherence definition, it can compare the distribution of those categories between groups. A pairwise test focuses on a particular two-group contrast rather than evaluating all groups in one comparison.
Such a test is an unadjusted comparison: it does not account for participant characteristics unless those characteristics are incorporated through a separate model. Its interpretation depends on the data being represented appropriately as counts and on the test’s assumptions being suitable for the observed data. The registry does not report the outcome counts, the test results, or whether any assumption checks or alternative procedures were used.
What does logistic regression add?
The registry also describes binary logistic regression to compare the two interventions and usual care on adherence, with adjustment for potentially confounding covariates. In general, logistic regression models the probability of a binary outcome through the log odds. It can estimate associations between assigned group and adherence while accounting for other variables included in the model. A model-based contrast can therefore differ from a simple comparison of unadjusted proportions.
The record says demographic covariates such as age and education would be included when randomized groups differed significantly at baseline, using a liberal significance level of 0.20 to achieve conservative adjustment. This is the stated selection rule, not evidence that any specific covariate was actually included. The registry does not report baseline comparisons, the final model specification, the estimated coefficients, or the form in which any treatment contrasts would be presented. It also does not report whether the regression estimates were interpreted as odds ratios, predicted probabilities, or another model-based quantity.
In general, adjustment can account for chance imbalances in measured covariates, but it cannot address unmeasured factors or correct poorly measured variables automatically. Randomization is intended to support comparable groups on average; baseline differences can still occur by chance. The record’s proposed adjustment rule focuses on measured demographic differences and does not describe any other adjustment strategy.
How should the two adherence outcomes be distinguished?
The trial title identifies both receipt of all needed screening and receipt of any needed screening. Each is a binary endpoint, but each uses a different threshold for classifying adherence. Analyses of these outcomes answer related but distinct questions. A participant who meets the “any” definition need not meet the “all” definition. The registry does not provide detailed scoring rules or results by screening type, so the precise construction of each endpoint cannot be reconstructed from the record.
In general, presenting more than one outcome can broaden the clinical description, while also creating more opportunities for comparisons. The registry record does not specify whether the two adherence outcomes were co-primary, how they were ordered, or whether a multiplicity adjustment was planned. Those details should not be inferred from the fact that both appear in the primary outcome title.
What does multiple imputation mean in this record?
The description names multiple imputation as a sensitivity analysis to impute adherence outcomes. In general, imputation uses observed information to generate plausible values for outcomes that are missing, creating multiple completed datasets rather than treating a single guessed value as certain. Estimates from those datasets are then combined so uncertainty associated with missing values is reflected in the analysis.
Imputation is not assumption-free. Its usefulness depends on the variables and model used, and on assumptions about how missingness relates to observed and unobserved information. The registry does not report the imputation model, included variables, number of imputed datasets, missing-outcome frequency, or results of the sensitivity analysis. Therefore, the stated plan indicates that missing outcomes were to be examined in an additional analysis, but does not show how influential missing data were.
Finally, a planning calculation based on an observed effect is not observed power and is not the same as a prospective sample-size justification. General planning illustrations describe assumptions about a future comparison; they do not supply missing outcome estimates or replace the trial’s results. The registry record does not report the trial’s own sample-size justification, and any analysis or planning details beyond those explicitly stated are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry describes pairwise chi-square testing across randomized arms and also identifies two adherence definitions: receipt of all needed screening and receipt of any needed screening. In general, making several comparisons can increase the chance of at least one apparently notable result arising by chance. A prespecified approach to multiplicity can help define how the family of tests is interpreted. The registry record does not report whether a multiplicity adjustment or hierarchy among comparisons and outcomes was planned.
The record’s description of regression comparisons does not resolve this uncertainty. It states that logistic regression would compare the interventions and usual care, but does not specify which contrasts were primary, whether both adherence definitions were analyzed in parallel, or how multiple estimates were to be interpreted. Those details are not reported in the registry record.
For missing data, the record names multiple imputation as a sensitivity analysis for adherence. It does not report how many outcomes were missing, why they were missing, whether missingness differed by randomized arm, or the imputation assumptions and model. Without those details and results, the robustness of the adherence findings to missing data cannot be assessed.
The registry record does not report an analysis population definition, such as whether participants were analyzed according to randomized assignment, or how participants with incomplete follow-up were handled in the primary analysis. It also does not report exclusions after randomization or a flow of participants through follow-up. These omissions limit assessment of how closely any eventual analysis followed the randomized comparison. The planned sensitivity analysis is useful context, but it is not evidence that missing data had no effect.
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 |
|---|---|---|---|
| Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) | 0 | 382 | 0.0% |
| Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) | 0 | 388 | 0.0% |
| Arm III Usual Care (UC) | 0 | 193 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) | 0 of 382 |
| Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) | 0 of 388 |
| Arm III Usual Care (UC) | 0 of 193 |
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 |
|---|---|
| Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) | 0 of 382 |
| Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) | 0 of 388 |
| Arm III Usual Care (UC) | 0 of 193 |
The registry lists adverse-event counts separately for each arm. For the tailored interactive DVD arm, the number at risk is 382, with 0 serious adverse events, 0 other adverse events, and 0 deaths recorded. For the DVD plus patient navigation arm, the number at risk is 388, with 0 serious adverse events, 0 other adverse events, and 0 deaths recorded. For usual care, the number at risk is 193, with 0 serious adverse events, 0 other adverse events, and 0 deaths recorded.
These entries describe what the registry reports for the listed at-risk groups. They do not give event narratives, ascertainment procedures, severity definitions beyond the serious/other categories, or a safety follow-up timeframe. The record lists no serious adverse-event terms. The zeros should not be interpreted as proof that no health events of any kind occurred; they indicate that none are entered in these reported event categories.
Safety counts also do not answer the primary screening-adherence question. They are a separate part of the record and cannot be used to infer the comparative effect of the interventions on screening. The registry record does not report additional context needed to evaluate the completeness of adverse-event collection.
12. What the Result Does, and Does Not, Mean
This trial record describes a randomized comparison of three screening-support strategies for rural women needing breast, cervical or colorectal cancer screening. It identifies the core outcome as receipt of all needed screening and any needed screening during follow-up up to 12 months. It also outlines planned statistical methods and reports adverse-event counts by arm.
What the record does not establish is the comparative result. It does not report the primary outcome counts or percentages, the estimated differences between groups, confidence intervals, or p-values. Accordingly, it cannot show from the registry results whether one approach had greater adherence than another, by how much, or with what precision. The trial’s completed status and stated enrollment do not fill that information gap.
In general, a randomized design supports comparisons based on assigned groups, but interpretation still depends on outcome definitions, follow-up, missing data, analysis choices, and the precision of estimates. The record gives some planned analytic details, including adjustment for selected baseline demographic covariates and a multiple-imputation sensitivity analysis, but does not report whether those procedures were implemented or what they found. It also does not report the analysis population or detailed outcome construction.
The listed zero adverse-event counts are limited to the categories recorded in the registry and do not describe every possible health event. Likewise, listed secondary outcomes concerning intervention costs and cost-effectiveness do not constitute findings; their results are not reported in the registry record.
The appropriate reading is therefore narrow: the record documents the trial question, arms, endpoint timeframe, proposed analyses, and recorded safety counts, but not the primary comparative outcomes. No claim that a particular intervention does or does not improve screening adherence can be drawn from these registry entries alone.
13. Why This Trial Matters Statistically
Statistically, the study addresses a practical comparison among several approaches rather than a single intervention-versus-control contrast. The randomized parallel design creates a framework for comparing assigned strategies, while the two adherence definitions distinguish partial receipt of needed screening from completion of all needed screening. That distinction matters because an intervention could be associated with one threshold without showing the same pattern at the other.
The analysis description also illustrates how trial results may be examined at more than one level. Pairwise chi-square tests offer initial unadjusted comparisons; logistic regression can account for selected measured baseline characteristics. Multiple imputation is named as a sensitivity analysis for missing adherence outcomes. Each method addresses a different analytic concern, and none removes the need to report outcome estimates, uncertainty, assumptions, and analysis populations.
At the same time, the record illustrates an important limit of registry interpretation: a clear question and a stated analysis plan are not substitutes for results. Without the arm-specific endpoint findings and estimates of uncertainty, the strength and precision of the evidence cannot be assessed. This is especially consequential when more than one outcome definition and several group comparisons are part of the stated question.
The registry also lists intervention costs and cost-effectiveness as secondary outcomes, indicating that the study intended to consider resource use alongside screening adherence. Their results are not reported in the registry record, so the record cannot support conclusions about those comparisons either. The statistical value of the trial’s design can only be judged fully when outcome reporting makes the estimates and their limitations available.
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 main limitation of the registry record for interpreting this trial is that it does not report primary outcome results. Counts, percentages, comparative estimates, confidence intervals, and p-values for both adherence definitions are not reported in the registry record. This prevents evaluation of effect direction, magnitude, and precision.
Important details about endpoint construction are also absent. The record does not explain how the screening needed by each participant was determined, how completion was verified, or whether outcomes were reported separately for breast, cervical, and colorectal screening. Those details are necessary to understand exactly what qualifies as “any” or “all” screening.
The analysis plan is described but its implementation is not documented. Baseline covariate results, the final regression specification, multiplicity handling, analysis population, and participant flow are not reported. Although multiple imputation is named as a sensitivity analysis, the missing-outcome frequency, imputation model, assumptions, and results are not reported. The randomization procedure, allocation concealment, adherence to assigned interventions, and intervention delivery fidelity are also not reported in the registry record.
The safety entries are limited to the reported serious and other adverse-event categories and deaths. The record does not describe ascertainment methods or a safety follow-up window. Finally, the registry lists intervention costs and cost-effectiveness as secondary outcomes but does not report their results. These reporting gaps constrain interpretation of both the main endpoint and the broader comparative assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Rural Interventions for Screening Effectiveness — NCT02795104.
- Registry record last updated 2023-10-02; status last verified 2023-09.
- Results first posted 2023-10-02.
- 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.
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18. Record Summary
NCT02795104 is a completed, randomized, parallel-group trial with no masking, comparing a tailored interactive DVD, the DVD plus telephone-based patient navigation, and usual care brochures for rural women needing breast, cervical or colorectal cancer screening. The registry lists enrollment of 985 and a primary outcome timeframe of up to 12 months.
The primary outcome concerns receipt of all needed screening and any needed screening. The record describes initial pairwise chi-square tests, logistic regression with adjustment for selected baseline demographic covariates, and multiple imputation as a sensitivity analysis. It does not report primary outcome results, effect estimates, uncertainty measures, analysis populations, or the results of the listed secondary cost outcomes.
Adverse-event entries list 0 serious events, 0 other events, and 0 deaths in each arm. Those entries should be interpreted within the categories and context recorded in the registry, not as a comprehensive account of all health events.