A Supervised Prehabilitation Program for Patients With Pancreatic Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Supervised Prehabilitation Program for Patients With Pancreatic Cancer (NCT05692323), a na na study. The primary outcome is PREHAB Feasibility.

2. Clinical Question

3. Trial Design

The registry describes NCT05692323 as a single-group study of a supervised prehabilitation exercise program for patients with pancreatic cancer. It lists Cedars-Sinai Medical Center as the sponsor and an enrollment of 16. The study phase is listed as NA, allocation as NA, and masking as none. There is no randomized assignment or concurrent control group described in the record.

The intervention is named PREHAB and classified as other. The arm is titled “Supervised Prehabilitation Exercise Program.” The arm description itself is blank, so the record does not give a detailed account of the exercise activities, session schedule, supervision, or support offered. Such protocol details are not reported in the registry record.

The stated purpose is to assess use of an exercise program in people with pancreatic cancer. The primary outcome is PREHAB feasibility, measured by tracking attendance at sessions over the timeframe from baseline to 3 months. PREHAB is defined as feasible if 50% of participants attend at least 60% of scheduled sessions. A secondary outcome is named PREHAB Program Safety. Although the record lists two outcome measures, further detail about the safety measure is not reported in the registry record.

The study start date is 2023-05-15, the primary completion date is 2025-10-15, and the status is active, not recruiting. These registry fields describe the study’s recorded status and dates; they do not by themselves establish that outcome analyses are complete. The record reports zero analyses. It therefore does not provide an inferential comparison, an analysis population, or a statistical result for the primary feasibility question.

Because the study has no comparison arm, observed attendance or safety counts would describe participants in the program group. They would not estimate a contrast with another treatment or establish what would have happened without the program. The registry record does not report a sample-size justification or a detailed statistical analysis plan.

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 PREHAB Feasibility, measured over From Baseline to 3 Months.

The primary endpoint is PREHAB feasibility, expressed as a count of participants and assessed from baseline to 3 months. The registry defines feasibility through attendance rather than through a clinical outcome: the program meets its criterion if 50% of participants attend at least 60% of scheduled sessions. Tracking attendance gives a direct way to assess whether participants take part in the planned program at the level specified by the study.

This type of endpoint can help distinguish an intervention that is deliverable and attended from one that may be difficult to implement. It does not, by itself, measure changes in cancer status, symptoms, physical capacity, or other health outcomes. The registry record does not report the number of participants who reached the attendance threshold, the attendance distribution, or whether the stated feasibility criterion was met. Therefore, the definition is available, but the primary endpoint result is not reported in the registry record.

The record does not further describe how scheduled sessions are counted, how missed or rescheduled sessions are handled, or how attendance is classified for participants with incomplete follow-up. Those operational details are not reported in the registry record and could affect interpretation of an attendance-based endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a participant-level attendance classification, summarized as a count. The registry’s feasibility rule combines two conditions: at least 50% of participants must attend at least 60% of scheduled sessions. Conceptually, the attendance records for each participant are used to determine whether that participant reaches the specified attendance level; the number meeting that level is then considered against the study’s stated feasibility criterion. The record does not report the observed count or how the calculation was carried out.

What does an attendance threshold measure?

An attendance threshold is an operational definition: it turns a broad concept, such as whether a program is feasible to deliver and attend, into a rule that can be evaluated from recorded participation. The threshold should be interpreted as the study’s chosen criterion, not as a universal definition of feasibility. Its meaning depends on how sessions are scheduled and recorded. The registry does not report how cancellations, missed sessions, rescheduling, or incomplete participation are handled, so those details cannot be assessed.

The endpoint is a count of participants, not a continuous measure of exercise exposure or a clinical outcome. Counts can be useful for implementation questions because they show how many people satisfy a specified criterion. A count alone, however, does not show the range of attendance experiences or explain why some participants attend less often. The registry record does not report individual attendance data or a distribution of attendance.

How would uncertainty be interpreted?

In general, a confidence interval describes the uncertainty around an estimate. For a proportion based on participant outcomes, it can indicate how much the estimated proportion might vary because the study includes a limited group rather than every person to whom the question might be relevant. A confidence interval would not correct for selection differences, missing attendance records, or lack of a comparator. No confidence interval or other uncertainty estimate for feasibility is reported in the registry record.

In general, statistical tests assess how compatible observed data are with a specified statistical model or hypothesis. Their interpretation depends on the analysis plan, outcome definition, assumptions, and data. The record lists zero analyses and does not report a test, p-value, or model for the primary outcome. It would therefore be inappropriate to infer a statistical finding from the feasibility rule alone.

What does the single-group design allow?

A single-group study can describe outcomes observed among participants who enter the program. It does not include a randomized or concurrent comparison group in this registry record. Without such a comparison, observed attendance cannot be interpreted as a treatment contrast. Likewise, safety counts in the program group do not show how those counts compare with another condition. The allocation field is NA and the study model is single group; no like-for-like control comparison is described.

The record does not report adjustment variables, subgroup analyses, repeated-measures methods, or other modeling choices. No protocol-specific statistical plan, sample-size justification, or interim analysis information is reported in the registry record. General statistical methods should not be mistaken for methods used by this study.

How should the safety counts be treated?

Safety results are reported as participant counts: the record lists 3 serious adverse-event participants among 16 at risk, 10 participants with other adverse events among 16 at risk, and 0 deaths. In general, a participant count indicates how many people were recorded in a category; it is distinct from an event count, because a person may potentially have more than one event. The record does not give enough detail to reconstruct event-level data or determine whether categories overlap.

The serious terms listed include Sepsis, Anemia, Fever, Diarrhea, and Confusion, each accompanied by 6.2%. The registry does not explain in this record how those term percentages were calculated or whether the terms represent unique participants or events. They should be read as registry-listed descriptive entries, not as evidence of cause or of a relationship to the exercise program.

What is missing for an independent analysis?

Independent evaluation would require the actual attendance outcome, a sufficiently detailed outcome definition, and information about missing or incomplete observations. The record does not report those data. It also does not report an analysis population, a statistical model, an estimate with uncertainty, or the handling of participants who did not complete follow-up. As a result, the available record supports description of the intended endpoint and some safety counts, but not recalculation or verification of the feasibility result.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Supervised Prehabilitation Exercise Program")
n      <- c(16)
events <- c(10)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Supervised Prehabilitation Exercise Program  16  10  62.5  35.4  84.8  38.6  81.5  38.3  81.6

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures, names PREHAB feasibility as the primary outcome, and identifies PREHAB Program Safety as a secondary outcome. It does not report a multiplicity strategy or explain whether any statistical testing was planned across outcomes. The record lists zero analyses, so no family of reported tests or adjusted inferential results is available to evaluate.

In general, multiplicity concerns arise when several outcomes, comparisons, time points, or subgroup analyses are examined. Repeated testing can increase the chance of a false-positive finding if results are interpreted without accounting for the testing strategy. Whether that issue applies in a particular study depends on its planned analyses; those plans are not reported in the registry record.

Missing-data methods are not reported. The record does not say how participants with incomplete attendance records or incomplete follow-up are handled, whether missing attendance is treated as failure to meet the threshold, or whether any sensitivity analysis is planned. These decisions can affect an attendance-based feasibility estimate, so the absence of this information limits interpretation.

An analysis population is also not reported. It is unclear from the registry record whether the primary endpoint is intended to include all enrolled participants, only those who begin the program, or another defined group. No intention-to-treat, per-protocol, or other population is identified. These omissions do not establish that particular methods were or were not used; they mean the methods are not reported in the registry record.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: sepsis (6.2%), anemia (6.2%), fever (6.2%), diarrhea (6.2%), confusion (6.2%).

For the Supervised Prehabilitation Exercise Program group, the registry reports 3 participants with serious adverse events among 16 at risk, 10 with other adverse events among 16 at risk, and 0 deaths. These are descriptive counts in the program group, not comparisons against a control group. Because the study is single group, the counts do not estimate a difference in safety relative to another intervention or usual care.

The registry lists Sepsis, Anemia, Fever, Diarrhea, and Confusion among the serious adverse-event terms, each with 6.2%. These entries do not, on their own, establish how many events occurred, whether the terms refer to unique participants, when the events occurred, or whether they were judged related to the program. Causal attribution and further event details are not reported in the registry record.

Counts of participants with events should not be confused with counts of all events, since a participant may experience more than one event. The record does not provide enough detail to assess overlap between serious and other adverse events or to calculate a comparative safety measure. These figures describe what is recorded for the group; they do not establish that the program caused or prevented an event.

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

The registry record establishes the study’s stated feasibility criterion and describes a supervised exercise program for people with pancreatic cancer. It also reports descriptive adverse-event counts for the program group. These registry entries define the study’s question and some of the information collected, but they do not supply an analyzed primary outcome.

In particular, the record does not state how many participants attended at least 60% of scheduled sessions. It therefore does not show whether at least 50% of participants met the study’s threshold, which is the stated basis for calling PREHAB feasible. The feasibility definition should not be mistaken for a finding. No estimate of uncertainty or statistical analysis of attendance is reported either.

The adverse-event information is limited to counts and listed serious-event terms. With no concurrent comparison group and no reported causal attribution, those entries cannot establish whether events were caused by the exercise program or how safety compares with another approach. The absence of reported deaths in the group is a descriptive registry entry, not a comparative safety conclusion.

This record also does not establish effects on cancer outcomes, physical function, symptoms, or quality of life. Those outcomes are not identified as the primary question in the posted information. No treatment benefit or lack of benefit can be inferred from a feasibility endpoint or from the safety counts alone.

The appropriate reading is therefore narrow: the registry describes a single-group study, specifies an attendance-based feasibility rule, and records limited safety counts. Whether the feasibility rule was met and what the complete outcome findings are remain unreported in the registry record.

14. Why This Trial Matters Statistically

Feasibility is an important statistical question for an intervention that depends on participants attending scheduled sessions. An attendance-based endpoint makes implementation measurable and can help show whether participants engage with the program at the level its investigators defined. In this study, the registry sets a criterion using the proportion of participants and the proportion of scheduled sessions attended.

That precision in defining a threshold is useful, but a definition alone cannot answer the question. The observed attendance count and its uncertainty are needed to judge whether the criterion was reached and how stable that judgment may be. Those results are not reported in the registry record. This distinction between a prespecified operational rule and an observed finding is central to sound interpretation.

The single-group design also shapes the statistical meaning of any reported outcomes. It can describe participation and events among the enrolled participants, but without a comparison group it cannot estimate a contrast with another care strategy. This is particularly important when readers are tempted to interpret safety counts as evidence of a causal effect.

The record illustrates why outcome definitions, analysis populations, missing-data handling, and statistical plans matter. For attendance, incomplete follow-up or ambiguous session accounting can affect who is classified as meeting the threshold. For safety, event-level details and attribution affect what counts can convey. Those methodological details are not reported in the registry record, which leaves important questions open even though the study’s primary criterion is stated.

Statistically, the study is most informative when treated as a feasibility-focused, descriptive investigation rather than a comparative treatment trial. The posted record identifies the intended question and selected descriptive safety data; it does not provide the primary outcome analysis needed to answer that question.

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.

The most immediate limitation is that the registry record does not report the primary feasibility result. Although the attendance rule is specified, the number of participants who met it and whether the threshold was reached are not stated. The record lists zero analyses, so no statistical estimate or uncertainty measure can be assessed.

The study is single group, with no concurrent comparator. Consequently, any attendance or safety observations describe participants in the program and cannot establish a difference relative to another condition. The record also lists masking as none. Further details about how outcomes were collected or assessed are not reported in the registry record.

The enrollment is 16. The record does not report a sample-size justification, so the planned precision or rationale for this enrollment cannot be evaluated. It also does not report an analysis population or how missing attendance and follow-up data are handled. For an endpoint based on scheduled-session attendance, these details matter to the classification of participants.

The intervention description is limited to a supervised prehabilitation exercise program. Exercise content, session schedule, attendance-recording procedures, and the handling of schedule changes are not reported in the registry record. The safety information is also limited: event timing, duration, severity criteria beyond the serious designation, causal attribution, and the relation between participant counts and individual events are not described.

Finally, although the study is listed as active, not recruiting, the record does not include an analysis of the primary outcome. The listed status and dates should not be treated as substitutes for results. These limitations restrict the conclusions that can be drawn from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Supervised Prehabilitation Program for Patients With Pancreatic Cancer — NCT05692323.
• Registry record last updated 2026-08-19; status last verified 2026-08.
• Results first posted 2026-04-15.
• 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

NCT05692323 is a single-group study of a supervised prehabilitation exercise program for people with pancreatic cancer, sponsored by Cedars-Sinai Medical Center. The registry lists an enrollment of 16, no masking, and a study status of active, not recruiting.

The primary outcome is PREHAB feasibility from baseline to 3 months, defined as at least 50% of participants attending at least 60% of scheduled sessions. The registry record does not report the observed attendance result and lists zero analyses. PREHAB Program Safety is named as a secondary outcome.

For the program group, the record reports 3 participants with serious adverse events among 16 at risk, 10 with other adverse events among 16 at risk, and 0 deaths. The record does not include a comparator or enough detail for causal interpretation. The primary completion date is 2025-10-15; the primary outcome analysis is not reported in the registry record.