Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study (NCT06063603), a non-randomized na study. The primary outcome is Feasibility of Intervention.

2. Clinical Question

The central question is whether the intervention and its components can be delivered and assessed in the intended population in preparation for a future pragmatic trial. The registry describes cancer pain as an important health-disparity concern and identifies rural-dwelling and Hispanic cancer survivors as the populations of interest. It does not report a comparative question about whether the intervention improves pain relative to usual care or another treatment.

That distinction matters for interpreting the study. Feasibility outcomes concern implementation, participation, and receipt of intervention components. They can help identify whether a later trial’s procedures are workable, but they are not themselves estimates of comparative treatment effects. The record’s primary outcome definition refers to receipt of key components, while the population description also notes that some participants were surveyed about their experience. The registry does not report the component-specific counts, the resulting proportion, or a numerical survey result.

3. Trial Design

ASCENT is titled as a pilot test of a pain management intervention preparatory to a future pragmatic trial. The registry classifies it as non-randomized, unmasked, and sequential, with phase listed as NA. Enrollment was 51. The study status is completed; the recorded start date is 2023-05-22 and the primary completion date is 2024-02-02. Mayo Clinic is the sponsor.

The three groups have different descriptions. Group I is labeled pain management. Group II consists of intervention providers who complete an interview about the study. Group III consists of medical oncology providers who participate in a focus group. Because allocation is non-randomized, these groups do not form a like-for-like control comparison. In particular, the provider interview and oncology-provider focus group are not described as control interventions for the participant pain management group.

The listed intervention components span behavioral, educational, and procedure categories: cancer pain management, cognitive behavior therapy, educational intervention, exercise, acupuncture therapy, massage therapy, discussion, and interview. The registry record does not give a detailed protocol for how these components were delivered, which participants received each component, or how the sequential model operated. Those details are not reported in the registry record.

The primary outcome is feasibility of the intervention, assessed by the proportion of participants who received key intervention components within up to 60 days. The outcome description also states that participants who completed all three visits were sent a survey about their ASCENT pilot experience. Of 41 participants who completed all three visits, 35 completed the survey. These figures describe visit and survey completion; they do not by themselves give the numerical result for receipt of key intervention components.

The registry record does not report random assignment, a masking procedure, or a conventional comparison group. It also does not report a statistical analysis plan or an explanation of how the pilot results would be used to refine the future trial.

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: Only Group 1 were actual participants who were enrolled in the study and received the intervention. Data was only collected for Group 1, so this is the only data reported. Group 2 consisted of interventionalists (provided the intervention to Group 1 participants). Group 3 were Medical Oncology providers. Neither Group 2 nor 3 received any intervention or were enrolled in the study. Groups 2 and 3 participated only in study development.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Participants who completed all three visits were sent a survey about their experience with the ASCENT pilot--of the 41 who completed all 3 visits, 35 completed the survey.

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: Groups II and III were not enrolled to the study. They participated in development and evaluation of this pilot as providers. These groups did not receive the study intervention, and no demographic or outcome data was collected from these groups. Only data from Group 1 is reported.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of Intervention, measured over Up to 60 days.

The primary endpoint is titled “Feasibility of Intervention.” It is defined as the proportion of participants who received key intervention components, with assessment within up to 60 days. This type of endpoint addresses whether the intervention can be delivered as intended and whether participants receive its specified elements. In a preparatory pilot, those implementation questions can inform decisions about how to refine procedures for a later pragmatic trial.

A proportion requires a clearly defined numerator and denominator: the numerator is the participants meeting the stated receipt criterion, and the denominator is the participants considered eligible for that endpoint assessment. The registry record does not report the actual count meeting the criterion or the resulting proportion. It also does not specify which components were considered key, how receipt was verified, or how participants without an assessment were handled. Those details are not reported in the registry record, so the endpoint value cannot be reconstructed from the posted description.

The registry also reports survey participation among those who completed all three visits: 41 completed all three visits and 35 completed the experience survey. These figures describe the survey process, not the primary endpoint result. The record does not report a numerical summary of survey responses. Feasibility is distinct from evidence of a comparative effect on pain or another clinical outcome; no such comparative conclusion follows from this endpoint definition.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry labels the study non-randomized, unmasked, and sequential. These design labels describe how the study was organized; they do not supply an analysis method. Randomization, when used, assigns participants to groups by chance and can help balance measured and unmeasured characteristics on average. Because allocation was non-randomized, group membership may be related to participant or study-process characteristics. Comparisons across groups would therefore require a clear rationale and appropriate adjustment, and even adjustment cannot guarantee removal of confounding. The registry record does not report an adjusted comparative analysis.

What does a feasibility proportion mean?

A proportion summarizes how many participants satisfy a defined condition relative to a specified denominator. For the primary outcome, the condition is receipt of key intervention components. To interpret such an estimate, readers need to know which components qualify, what counts as receipt, who is included in the denominator, and how missing assessments are handled. The registry describes the outcome as a proportion but does not report the numerator, denominator, or proportion. Those operational and numerical details are not reported in the registry record.

A confidence interval, in general, expresses uncertainty around an estimated quantity. For a proportion, it can show a range of values reasonably compatible with the observed data under the interval’s assumptions. A narrow interval generally reflects greater precision, while a wide interval reflects less precision. No confidence interval for the primary outcome is reported in the registry record, so its precision cannot be assessed.

Why does the study design matter?

In an unmasked study, participants and study personnel are not described as blinded to the intervention. For outcomes involving delivery, participation, or participant-reported experience, awareness of the intervention may affect reporting or how procedures are carried out. That possibility does not establish that bias occurred; it identifies a design feature relevant to interpretation. The registry record does not report masking procedures beyond the classification of none.

The listed model is sequential. In general, a sequential design may organize study activities or groups in a specified order, but the label alone does not reveal the sequence, transition rules, or analytic consequences. The registry record does not describe how the model was implemented. The groups’ descriptions indicate different activities: pain management for Group I, an intervention-provider interview for Group II, and a medical oncology provider focus group for Group III. The groups should not be read as randomized treatment and control arms.

What do the planning assumptions imply?

The registry includes assumptions for planning illustrations based on an observed effect: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. For non-time-to-event outcomes, the planning illustrations are expressed as participants per arm for 80% or 90% power; time-to-event illustrations, if applicable, are expressed as total events. These assumptions describe planning illustrations, not the trial’s own design or a reported sample-size justification. The record does not report that the pilot was designed around these assumptions, and no numerical sample-size justification is reported in the registry record.

Power is the probability that a specified analysis will detect an effect of a stated size under its assumptions. A planning calculation can describe a proposed future study’s requirements, but it does not measure the chance that the completed pilot produced a statistically significant result. The planning illustrations are not observed power. Since the registry entry does not report the primary outcome estimate or its analysis, no observed effect can be assessed from the record. The registry record also does not report the model or test used for the primary endpoint.

How should missingness and multiple outcomes be considered?

Missing data can affect interpretation when participants with unavailable outcomes differ from those with observed outcomes. The visit and survey counts establish that completion was not universal among those described, but the registry does not state why participants did not complete visits or the survey, how missing outcome information was handled, or whether any imputation or sensitivity analysis was used. These methods are not reported in the registry record.

Multiplicity arises when several outcomes or comparisons are tested, because repeated testing can increase the chance of at least one apparently unusual result. The registry lists six outcome measures, but reports zero analyses. It does not specify a multiplicity adjustment, a hierarchy among outcomes, or an inferential testing plan. These details are not reported in the registry record. With no posted inferential results, there are no p-values or confidence intervals to interpret for multiplicity.

In general, an analysis population defines which participants contribute to a given estimate. A complete-case population includes only participants with the necessary observed data; other approaches can retain participants through explicit missing-data methods. The registry identifies participants who completed all three visits as the group sent the experience survey, but does not state a formal analysis population for the primary endpoint. The endpoint denominator and analysis population are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, but it reports zero analyses. It does not identify a prespecified hierarchy of outcomes, distinguish confirmatory from exploratory analyses, or describe any adjustment for multiple testing. Multiplicity methods and a statistical analysis plan are not reported in the registry record. Since no inferential results are posted for the primary outcome, there are no reported p-values or confidence intervals for which multiplicity handling can be evaluated.

The primary endpoint is defined as a proportion of participants receiving key intervention components. The registry does not report the numerator, denominator, or proportion. It also does not specify how participants with missing information on component receipt were treated. Missing-data methods, including any imputation or sensitivity analyses, are not reported in the registry record.

For the experience survey, the record states that participants who completed all three visits were sent a survey; 41 completed all three visits and 35 completed the survey. The record does not describe the survey analysis population, response handling, or any method for accounting for nonresponse. These details are not reported in the registry record. The visit and survey counts should therefore be read as participation information rather than as a complete-case analysis of the primary endpoint.

The registry does not state whether all enrolled participants were included in each outcome analysis or whether any exclusions were applied. Definitions of the analysis populations are not reported in the registry record. Without those definitions and endpoint-specific counts, the extent and potential effect of missing data cannot be determined.

11. 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.

For Group I (Pain Management), the registry records 51 participants at risk for serious adverse events and zero serious adverse events. It also records 51 participants at risk for other adverse events and zero other adverse events, with zero deaths. These figures describe the safety counts posted for that group.

For Group II (Intervention Providers) and Group III (Medical Oncology Providers), the registry records zero participants at risk and zero events. Counts of zero events in groups with zero participants at risk do not provide safety information about exposure in those groups. The record does not describe them as participant treatment arms.

A zero event count in Group I means no events were recorded in the registry fields; it does not establish that the risk of an event is absent. Interpretation depends on the population monitored, the observation period, event definitions, and completeness of reporting. The registry record does not provide additional detail about those aspects, or a list of serious adverse event terms. No conclusion about comparative safety can be drawn because the study is non-randomized and does not provide a like-for-like control comparison.

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

The record documents a completed, non-randomized pilot intended to refine a pain management intervention before a future pragmatic trial. It identifies rural-dwelling and Hispanic cancer survivors as the populations of interest, lists intervention components, and defines feasibility in terms of receipt of key components within up to 60 days. It also reports that 41 participants completed all three visits and 35 completed the experience survey.

Those details show what the pilot set out to study and provide limited information about visit and survey completion. They do not give the primary feasibility proportion, the component-specific delivery counts, or a numerical summary of participant experience. The registry record does not report a target for acceptable feasibility, so the posted information cannot establish whether a prespecified benchmark was met.

The record does not establish whether the intervention improves pain, changes health outcomes, or is superior to another approach. There is no randomized comparison, and Groups II and III are described as provider-focused activities rather than control arms. No treatment-effect estimate or inferential analysis is reported in the registry record. Accordingly, neither an effect nor the absence of an effect can be inferred from the posted entry.

For a future trial, a pilot can be useful for identifying implementation questions and refining procedures. The registry’s stated purpose is preparatory, but it does not report which intervention components were changed, what operational lessons were identified, or how the future trial would be designed. Those conclusions are not reported in the registry record. The documented information is therefore descriptive and should not be interpreted as evidence of clinical benefit or as a definitive assessment of feasibility.

13. Why This Trial Matters Statistically

Clinical studies intended to address disparities need to establish that the intervention and trial procedures can be delivered in the populations they aim to serve. ASCENT is explicitly framed as preparation for a future pragmatic trial, with rural-dwelling and Hispanic cancer survivors as its focus. Its feasibility endpoint is therefore relevant as a trial-development question: whether participants receive key elements of the intervention.

The statistical challenge is that a feasibility question needs transparent definitions. A proportion is only interpretable when the component-receipt criterion and denominator are clear, and uncertainty depends on the amount and pattern of missing information. The registry identifies the endpoint concept and timeframe but does not report the resulting value or its calculation details. This limits quantitative assessment, even though the study’s preparatory aim is clear.

The design also highlights a distinction between a pilot’s implementation work and a comparative treatment evaluation. Non-randomized allocation and groups with different activities do not create a like-for-like control comparison. For this study, the registry’s stated purpose supports focusing on intervention refinement rather than treating group differences as causal evidence.

The entry also records visit and survey participation, which can be useful in describing study processes. Those counts are not a substitute for the primary endpoint estimate or for survey results. Clear reporting of denominators, component receipt, missingness, and the analysis population would help readers judge the practical lessons available for planning a future trial. These details are not reported in the registry record.

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 for statistical interpretation is that the registry record describes the primary feasibility outcome but does not report its numerical result. No numerator, denominator, estimate, confidence interval, or p-value for the proportion receiving key intervention components is posted. The record also does not define which components were considered key or how receipt was assessed. As a result, the endpoint cannot be independently quantified or evaluated for precision.

The study is non-randomized and unmasked. The registry describes three groups with different activities, not a participant-level treatment group and comparable control group. This structure does not support a like-for-like comparison of intervention effects. The detailed operation of the sequential model is not reported in the registry record.

Although the registry records enrollment of 51, it also states that 41 participants completed all three visits and 35 completed the experience survey. Reasons for non-completion, survey findings, the primary endpoint denominator, and missing-data handling are not reported. These counts alone do not establish why data were unavailable or how completion relates to intervention receipt.

The intervention is represented by a list of components, but Group I’s description refers readers to a detailed description that is not included in the registry entry summarized by these registry entries. Delivery procedures, component-specific exposure, and any refinements made during the pilot are not reported in the registry record. The statistical analysis plan, sample-size justification, analysis populations, and multiplicity strategy are also not reported. These gaps make it difficult to assess how the pilot’s observations were meant to inform later trial decisions.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study — NCT06063603.
• Registry record last updated 2025-09-18; status last verified 2024-03.
• Results first posted 2025-09-18.
• 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.

18. Record Summary

ASCENT, NCT06063603, is a completed non-randomized, unmasked, sequential pilot sponsored by Mayo Clinic. The recorded enrollment is 51, and the listed phase is NA. The study is described as preparatory to a future pragmatic trial of a pain management intervention focused on rural-dwelling and Hispanic cancer survivors.

Group I is labeled pain management; Group II involves an interview with intervention providers, and Group III involves a focus group with medical oncology providers. Listed components include cancer pain management, cognitive behavior therapy, educational intervention, exercise, acupuncture therapy, massage therapy, discussion, and interview.

The primary outcome is feasibility, defined by the proportion receiving key intervention components within up to 60 days. The record notes 41 participants completed all three visits and 35 completed the experience survey. It does not report a numerical primary outcome result or survey summary. Safety fields record zero serious adverse events, zero other adverse events, and zero deaths among 51 at risk in Group I.