Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain (NCT05774197), a na na study. The primary outcome is Proportion of Patients Who Complete More Than 2/3rd of the Study Modules at the End of 4 Weeks of Intervention to Determine Feasibility of the STAMP+CBT App.

2. Clinical Question

This is a feasibility question about engagement with the app, not a controlled estimate of its effect on pain, opioid use, mood, or other clinical outcomes. The registry describes surveys at baseline, during the 4-week intervention period, and 2 weeks post intervention, with the latter assessment identified as 6 weeks from baseline. It does not report outcome values for those assessment points.

3. Trial Design

The registry identifies this as a completed, single-group study sponsored by the University of Oklahoma. The study is titled “Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain,” and its official title describes an mHealth approach combining pain-CBT, opioid monitoring, and self-management support for advanced cancer patients with chronic pain. The stated purpose was to develop and pilot test the STAMP+CBT app.

Enrollment is recorded as 52. The phase entry is NA, allocation is NA, masking is none, and the model is single group. Those design entries do not describe a randomized comparison or a blinded assessment. There is no like-for-like control group in the registered design, so outcomes cannot be read as a direct comparison between app users and a separate control group.

The intervention description says the app makes daily surveys available to assess pain, stress, mood, and related symptoms. It also says that tailored education is disseminated based on patient-reported symptoms. Cognitive behavioral therapy for pain is listed as the behavioral intervention. The record’s description does not specify further details of the delivered content, adherence support, or how individual app use was managed.

The primary outcome is framed around app-module completion during a four-week intervention. The record also describes baseline surveys and a post-intervention assessment 2 weeks after the intervention period, identified as 6 weeks from baseline. The study is marked completed, but dates or completion status do not substitute for a reported outcome value. The registry record does not report the primary result, a statistical analysis plan, or an analysis population. It lists 2 outcome measures and 0 analyses.

Although a planning illustration may use a two-arm framework, that framework should not be mistaken for the actual study design. The registered study is single group, and the planning assumptions describe equal allocation between two arms. Such an illustration is not an account of participants assigned in this 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: Of 52 enrolled participants, 31 met inclusion criteria and assigned to the single arm study. Among 31 patients enrolled into the app, 16 completed all surveys.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Patients who enrolled in the study and used the app

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 Proportion of Patients Who Complete More Than 2/3rd of the Study Modules at the End of 4 Weeks of Intervention to Determine Feasibility of the STAMP+CBT App, measured over 4-weeks.

The primary endpoint concerns feasibility of using the STAMP+CBT app. Its title describes the proportion of patients who complete more than 2/3rd of the study modules at the end of 4 weeks of intervention. The outcome is listed in participants, with its parameter described as a count of participants. The record therefore presents the endpoint as a participant-based completion measure, while using both proportion and count language in the title and outcome details.

The endpoint description gives a related operational criterion: the intervention would be considered feasible if more than 70% of subjects complete any activity on the app at least 50% of days on study. This criterion is not identical in wording to the title’s module-completion threshold. The registry record does not clarify how the module-completion measure and the app-activity criterion relate to each other, or which precise calculation was used in the final assessment.

Engagement is relevant to a pilot of a smartphone intervention because the intended approach depends on participants interacting with app surveys and educational content. A completion measure can describe whether participants used the intervention sufficiently for the feasibility question being asked. As a general statistical point, a proportion communicates the share of an eligible group meeting a defined criterion, while its interpretation depends on a clearly specified numerator, denominator, and assessment window.

The registry record does not report the observed count, proportion, denominator, or uncertainty interval for this endpoint. It therefore does not establish from the posted results whether the stated feasibility criterion was achieved.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the endpoint measure? The primary outcome is about app engagement: completion of study modules and activity across the intervention period. The title describes a proportion, whereas the outcome details identify the unit as participants and the parameter as a count of participants. In general, a count records how many participants meet a condition; a proportion expresses that count relative to a defined group. Both can be useful, but interpretation requires knowing who was eligible for the assessment and how incomplete observations were handled. Those details and the observed endpoint values are not reported in the registry record.

The registered description identifies more than 2/3rd of modules by the end of 4 weeks as the title’s completion threshold. It separately states that feasibility would be considered met if more than 70% of subjects completed any app activity on at least 50% of days on study. These definitions involve different criteria: module completion and activity frequency. Without a reported analysis definition, it is not possible to tell whether both were evaluated or how they were reconciled. The record also does not provide a participant-level completion distribution.

What would an uncertainty interval convey?

As a general statistical explanation, a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the analysis. For a feasibility proportion, it can show how compatible the data are with a range of underlying completion rates. An interval is not a guarantee that the true value lies within its limits, and its width depends on the amount and pattern of information available. No confidence interval for this endpoint is reported in the registry record, so its precision cannot be assessed.

A threshold-based feasibility question and an estimated proportion answer related but distinct questions. The threshold asks whether a prespecified operational target is satisfied. The estimate describes the observed engagement level, and an uncertainty interval can show how much sampling uncertainty surrounds it. A threshold alone does not reveal how far the observed estimate was from the target. Here, neither the observed estimate nor a statistical comparison with a target is reported.

What can the design establish?

The registry describes a single-group study, not a randomized comparison. In general, a single-group pilot can document whether an intervention was delivered and describe observed participation or outcomes. Without a concurrent control group, changes over time cannot be separated from other influences using a treatment-versus-control contrast. The record’s allocation entry is NA, and its masking entry is none. It does not report a comparative estimate or a plan for adjustment for other factors.

The intended assessment schedule includes baseline, the 4-week intervention period, and 2 weeks post intervention, identified as 6 weeks from baseline. Repeated assessments can describe measurements at different times, but their interpretation depends on the specific analysis, handling of incomplete follow-up, and definition of the population contributing at each assessment. Those analytic details are not reported in the registry record.

How should planning calculations be read?

The planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also define the effect to detect as a stated fraction of the observed effect. This is a planning framework, not a description of the registered single-group design. It should not be read as evidence that this trial assigned participants to two arms or used that approach in its own analysis.

In general, sample-size planning explores how much information might be needed to detect a chosen effect under stated assumptions. A planning illustration using participants per arm for 80% power is not observed power and is not the number enrolled in a trial. The registry record does not report the trial’s own sample-size justification, and the planning assumptions alone do not show whether the study was adequately sized for its feasibility objective. The observed effect needed by the illustration is not reported as a registry result in the information available for this analysis.

For outcomes measured as counts, the count’s meaning depends on the event definition, observation period, and population at risk. General count-data methods may need to account for over-dispersion: the possibility that variability exceeds what a simple model assumes. Over-dispersion can make uncertainty estimates too narrow if ignored. The registry record does not report a count model, a dispersion estimate, or a method used for the primary endpoint, so no claim can be made about whether such methods were needed or applied.

More broadly, the number of listed outcome measures does not disclose which statistical tests were used. There are 2 outcomes listed and 0 analyses. No p-value, standard error, confidence interval, or model estimate is reported for the primary endpoint. The result therefore cannot be independently interpreted for statistical significance or precision using the registry record.

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("STAMP+CBT App")
n      <- c(31)
events <- c(19)
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  STAMP+CBT App  31  19  61.3  42.2  78.2  43.8  76.3  43.7  76.3

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 2 outcome measures and 0 analyses. It does not report a statistical analysis plan, identify a hierarchy among outcomes, or describe a multiplicity adjustment. Multiplicity refers generally to the increased chance of a false-positive finding when several statistical hypotheses are tested. Whether that issue applies in a particular way depends on which outcomes and comparisons are actually tested and how they are organized. Since the analyses are not reported, the handling of multiplicity is not reported in the registry record.

The primary endpoint is described in terms of module completion and a separate activity-based feasibility criterion. The record does not clarify whether both formulations were analyzed, whether one was primary and the other supportive, or whether either was assessed against a formal statistical threshold. It also does not report any inferential test or uncertainty estimate. No conclusion about multiplicity-adjusted or unadjusted evidence can be drawn.

Missing-data procedures are not reported in the registry record. The record does not say how missed app surveys, incomplete module use, loss to follow-up, or unavailable assessments were classified in the primary endpoint. This matters generally because the denominator and the treatment of incomplete observations can change the interpretation of a completion proportion. It is not reported whether missing observations occurred, and none should be assumed.

The analysis population is also not reported. The endpoint description refers to patients who enrolled and used the app, but it does not specify a final analysis set or provide its size. Enrollment is listed as 52; the safety entry separately lists 31 participants at risk. The record does not explain how either figure relates to the primary endpoint analysis. No analysis population, imputation approach, sensitivity analysis, or participant flow for the endpoint is reported.

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.

The registry safety entry lists the STAMP+CBT App group with 31 participants at risk for serious adverse events and 0 affected. For other adverse events, it also lists 31 at risk and 0 affected. Deaths are recorded as 0, and no top serious-event terms are listed. These are the reported registry counts for the safety entry.

Zero recorded events in this entry should be read narrowly: no serious adverse events or other adverse events are listed as affecting participants in the reported group. It does not establish that no adverse experiences occurred outside the recorded categories or observation process. The registry record does not provide further detail on event definitions, collection methods, follow-up for safety, or the relationship between the risk set and the enrolled population.

The enrollment figure is 52, whereas the safety risk set is 31. The registry record does not explain this difference. The safety denominator should therefore be interpreted as the denominator listed for that safety outcome, not as the denominator for enrollment or the primary feasibility endpoint. Because the study is single group and has no registered control group, these safety counts do not support a comparative risk estimate or a causal conclusion about the app.

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

The registry record establishes that the study was designed as a single-group pilot of the STAMP+CBT app for advanced cancer patients coping with chronic pain. It identifies app engagement as the primary feasibility focus and gives a module-completion threshold and an activity-based criterion. The study is marked completed, and enrollment is recorded as 52. These registry entries describe the study’s registration and design.

The record does not report whether participants met the primary feasibility criterion. It gives no primary-outcome count, proportion, denominator, or uncertainty interval. A reader therefore cannot determine from the posted results whether module completion was high or low, how close an observed result was to a target, or how precise any estimate would be. Stating a criterion is not the same as reporting an outcome.

The study also cannot establish a comparative effect from its registered design. It has no randomized control group, and allocation is listed as NA. If the app were associated with changes in pain, mood, opioid use, or other outcomes, a single-group observation would not by itself distinguish an app-related change from other influences. The registry record does not report a clinical outcome estimate or a controlled comparison.

The safety entry records 0 serious adverse events, 0 other adverse events, and 0 deaths in its listed group and risk set. Those counts describe the posted safety data, but do not provide a comparative safety estimate or establish the absence of all possible adverse experiences. The record does not explain why the safety risk set differs from the enrollment figure.

Overall, the posted information supports an account of the intended feasibility assessment and registered study structure, not a conclusion that the intervention did or did not meet its goal. It also does not establish an effect on clinical outcomes. Further interpretation would require outcome values, analysis details, population definitions, and a clear account of missing observations, none of which is reported in the registry record.

14. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between testing an intervention’s feasibility and estimating its clinical effect. A feasibility endpoint asks whether participants engage with a new approach according to a defined operational target. That question can guide decisions about whether an intervention and its assessment procedures are workable. It is not equivalent to asking whether the intervention changes pain or another clinical outcome compared with an alternative.

The endpoint wording also illustrates why operational definitions matter. The title emphasizes completing more than 2/3rd of modules, while the description defines feasibility using the share of subjects completing any app activity on at least 50% of days. A clear account of how these criteria relate, along with the numerator and denominator for each, is important for reproducibility and interpretation. The registry record does not report that clarification or the resulting estimates.

Another statistical issue is the distinction between enrollment and an outcome-specific risk set. The record lists enrollment of 52 and a safety denominator of 31, without an explanation of their relationship. Different analyses can have different eligible populations, but readers need participant flow and analysis-set definitions to understand what each denominator represents. The primary endpoint denominator is not reported.

Finally, a planning illustration should be kept separate from the design and results of the pilot. The assumptions describe equal allocation between two arms, while the registered study is single group. This contrast makes it especially important not to treat hypothetical planning quantities as trial results or as evidence about what the actual design could establish. The statistical value of a pilot is clearest when feasibility estimates, their uncertainty, and the methods used to obtain them are reported alongside the study’s limitations.

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 important limitation for interpretation is that the registry record does not report the primary endpoint result. Without the observed completion count, proportion, denominator, or uncertainty interval, it is not possible to judge whether the stated feasibility criterion was met or how precisely feasibility was estimated.

The registered wording gives both a module-completion threshold and an activity-based feasibility criterion, but does not explain how they connect. The record does not report which definition governed the final endpoint calculation, how app use was measured, or how incomplete assessments were handled. This limits reproducibility and makes the endpoint’s interpretation uncertain.

The single-group design has no registered control group, and allocation is listed as NA. It cannot provide a controlled estimate separating intervention-related changes from other influences over time. Masking is listed as none. The record does not describe whether outcome assessment involved any additional safeguards against measurement or reporting bias.

Enrollment is listed as 52, but the safety entry lists 31 at risk; the record does not explain that difference. It also does not identify the primary analysis population or explain the denominator for the feasibility endpoint. Missing-data procedures and participant flow are not reported, so the extent and handling of incomplete follow-up cannot be assessed.

Although 2 outcome measures are listed, 0 analyses are reported. The record does not provide a statistical analysis plan, tests, uncertainty estimates, or multiplicity procedures. It also does not report the trial’s own sample-size justification. These omissions prevent assessment of analytic choices and statistical precision. The safety counts are descriptive and do not provide a comparative estimate; event definitions and collection details are not reported.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain — NCT05774197.
• Registry record last updated 2025-11-04; status last verified 2025-10.
• Results first posted 2025-10-09.
• 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

The registry record describes a completed, single-group pilot sponsored by the University of Oklahoma, with enrollment of 52. The intervention is the STAMP+CBT app, described as combining symptom surveys and tailored education, with cognitive behavioral therapy for pain listed as the behavioral intervention. Allocation is NA and masking is none.

The primary outcome concerns app-module completion during a 4-week intervention. Its description also gives an activity-based feasibility criterion. The registry record does not report the primary result, the analysis population, or statistical analyses; it lists 2 outcome measures and 0 analyses.

The safety entry lists 31 participants at risk in the app group, with 0 serious adverse events, 0 other adverse events, and 0 deaths. The relationship between this risk set and the enrollment figure is not reported. The record supports interpretation of the study’s intended question and design, but does not establish whether the feasibility criteria were met or whether the app changed clinical outcomes.