Ostomy Telehealth For Cancer Survivors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Ostomy Telehealth For Cancer Survivors (NCT02974634), a randomized na study. The primary outcome is Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare..

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. The listed groups are Ostomy Self Management Training and Usual Care. Random allocation is relevant because, in general, it is intended to make groups comparable at the start of a study; however, the registry record does not describe how the allocation sequence was generated, concealed, or implemented. With no masking, participants and study personnel were not reported as masked to group assignment.

The study status is completed. The record lists an enrollment of 216. Its brief summary separately says the principal investigator planned to enroll up to 176 subjects at three hospitals: University of Pennsylvania, Yale University School of Nursing, and City of Hope in Los Angeles. These statements do not match, and the registry record does not explain the discrepancy or clarify the realized enrollment by site. The brief summary also says patient telehealth education would be coordinated by the University of Arizona in Tucson, Arizona; it does not establish how delivery occurred in practice.

The study intervention is classified as other, and the phase is listed as NA. Participation was expected to last about 7 months according to the brief summary. The primary outcome timeframe names baseline, completion of the session at 5 weeks, and 6 month follow up. The record does not describe details such as the precise timing of each assessment, adherence to the training, or deviations from the assigned care. Those details 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.

Before assignment: All cancer survivors over 21 years of age who were at least six weeks after a surgical procedure that necessitated the creation of an intestinal stoma (fecal or urinary) were recruited. Survivors with temporary ostomies were included, and there was no maximum time since surgery.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent to treat participants who provided baseline and at least one followup measurement

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: Study sites are three diverse geographic areas to ensure participation of diverse populations. Each of our participating institutions has a large catchment area which includes rural and inner-city populations. These are patient populations that are often under served as there is difficulty in participating in support groups or

6. Primary Endpoint

The registry lists the primary outcome as Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare., measured over baseline, on completion of session ( 5 weeks) and 6 month follow up.

The primary outcome is the Patient Activation Measure (PAM), described as a score on a 100-point scale. It is intended to quantify patient engagement in healthcare. The registry states that 0 indicates lower activation and 100 indicates higher activation. Its description organizes activation into four stages: believing the patient role is important; having the confidence and knowledge to take action; taking action to maintain or improve health; and staying the course under stress.

Activation is relevant to a self-management education program because the program aims to build preparedness and capability for self-care. A measure of activation can therefore capture a broader aspect of engagement than a count of technical tasks alone. The record also lists self-efficacy as a secondary outcome, but does not report results for either measure.

PAM is specified as a continuous outcome summarized by a mean and standard deviation. Its timeframe includes baseline, completion of the session at 5 weeks, and 6 month follow up. The primary-outcome population is described as intent-to-treat participants who provided baseline and at least one follow-up measurement. The registry record does not report mean scores, standard deviations, between-group estimates, confidence intervals, or tests for any assessment time. Consequently, the outcome’s observed value and the precision of any group comparison are not available in the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design is listed as randomized and parallel, with OSMT compared with usual care. In a randomized study, assignment is intended to reduce systematic differences between groups at baseline. This is a general feature of randomization, not evidence that all prognostic factors were balanced in this particular trial. The record does not give the sequence-generation method, allocation concealment procedures, stratification factors, or other allocation details. Masking is listed as none, so the record does not describe blinding of participants or study personnel.

The primary measure is continuous: PAM is reported as a mean with standard deviation. In general, a mean describes the central level of scores, while a standard deviation describes the spread of scores among participants. A standard deviation is not the uncertainty of a group mean or of a treatment contrast. To judge the precision of a comparison, readers would need an estimate and an uncertainty measure such as a confidence interval. Neither is reported for PAM in this registry record.

The listed outcome timeframe includes baseline, completion of the session at 5 weeks, and 6 month follow up. Repeated measurements on the same participant are statistically related, so an analysis should account for that within-person dependence. General approaches can compare follow-up scores while adjusting for baseline, model change over time, or estimate a group-by-time pattern. These approaches target different quantities and rely on different assumptions. The registry record does not report which approach was used, whether all assessment times were analyzed together, or which contrast was designated as primary.

The primary-outcome population is described as intent-to-treat participants who provided baseline and at least one follow-up measurement. In general, an intent-to-treat approach aims to analyze participants according to their randomized assignment, regardless of adherence. The record’s additional requirement for baseline and follow-up data means it does not fully specify how participants without those measurements were handled. The analysis population, exclusions, and missing-data procedure are not reported in the registry record.

The registry lists 2 outcome measures and 2 analyses. That count alone does not explain how outcomes were selected, whether analyses were prespecified, or whether the study controlled the chance of false-positive findings across multiple tests. The primary outcome includes multiple time points, which also raises a multiplicity question: separate tests at each time can create more opportunities for a chance finding than a single prespecified contrast. In general, multiplicity can be addressed by defining a primary contrast in advance or by adjusting inference across tests. The registry record does not report a multiplicity strategy or a statistical analysis plan.

The record includes assumptions for a sample-size planning illustration based on an observed effect: two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect, and says non-time-to-event illustrations are expressed as participants per arm. Such calculations are planning illustrations, not observed power and not evidence of an outcome. The actual illustration values and the underlying observed effect are not reported in the registry record. The record also does not report a prospective sample-size justification or clarify how the listed enrollment relates to the summary’s stated plan to enroll up to 176 subjects.

For a continuous outcome, general concerns include the distribution of scores, influential observations, and whether the model’s assumptions fit the data. Repeated measurements require attention to correlation over time, and incomplete follow-up requires assumptions about why measurements are missing. These are general statistical considerations; the record does not describe diagnostic checks, model form, covariate adjustment, or sensitivity analyses. The actual statistical methods and outcome estimates are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 2 outcome measures and 2 analyses. It identifies PAM as primary and self-efficacy to perform ostomy self-management behaviors as a secondary outcome. PAM is measured at baseline, completion of the session at 5 weeks, and 6 month follow up. Because several assessment times are named, interpretation depends on which time point or contrast was designated as the main comparison. The registry record does not report that choice or a plan for controlling multiplicity across outcomes, time points, or analyses.

Missing data are particularly relevant to a follow-up outcome. The primary-outcome population is described as intent-to-treat participants who provided baseline and at least one follow-up measurement. The record does not state how many participants had each measurement, whether missingness differed by group, why measurements were missing, or how incomplete follow-up was handled in the analysis. It does not report imputation, a repeated-measures model, or sensitivity analyses. Without those details, readers cannot assess how missing observations may affect the reported comparison; in this record, the comparison itself is not reported.

The record does not give a statistical analysis plan, analysis-population details beyond the primary-outcome description, or results for the listed outcomes. These omissions limit assessment of prespecification and of how the analysis addressed repeated measurements and missing data. They do not establish that a particular method was or was not used; those details are not reported in the registry record.

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 5% reporting threshold.

The adverse-event record lists 0 serious adverse events in the Ostomy Self Management Training group and 0 in the Usual Care group. It also lists 0 other adverse events in each group. The record lists 8 deaths in the training group and 11 in usual care. These are the registry’s reported counts; they do not by themselves identify causes, timing, relatedness to the intervention, or whether events were adjudicated.

The at-risk counts listed for these safety fields are 106 for the training group and 110 for usual care. The record does not provide event descriptions among serious events, and the list of top serious terms is empty. A zero count in the posted fields should be read as no events reported in those fields, not as proof that no health events occurred. The death counts should not be interpreted as treatment-related without information about cause and attribution, which is not reported in the registry record.

These safety figures are separate from the PAM outcome and do not supply evidence about changes in patient activation, self-care, or quality of life. They also do not describe comparative safety with enough context to account for follow-up duration, definitions, or completeness of event collection, as those details are not reported in the registry record.

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

The registry record describes a completed randomized comparison of an educational self-management program with usual care for people with ostomies. It gives the rationale, intervention topics, primary measure, and its assessment times. This information helps readers understand what the investigators intended to study and how the treatment groups were defined.

It does not report the primary PAM results or the listed secondary outcome results. As a result, the record does not show the observed score levels, the size or direction of a between-group difference, or the precision of an estimate. It cannot support a conclusion that OSMT increased or decreased activation, or that the groups were equivalent. Lack of a posted estimate is not evidence that there was no difference.

The study’s broad aims include self-efficacy, knowledge, quality of life, mood, medical-service use, and financial burden, but intended outcomes are not findings. Likewise, a completed status is not a substitute for outcome data. The safety counts are registry entries for adverse events and deaths; without details about causes, attribution, and collection, they cannot establish that an event was or was not caused by the intervention.

For a complete statistical interpretation, readers would need the outcome estimates at relevant follow-up times, a measure of their uncertainty, and details of the analysis population, missing-data handling, and multiplicity strategy. Those items are not reported in the registry record. Until such results are available, the most defensible reading is descriptive: the trial was designed to compare OSMT with usual care on activation and other self-management-related outcomes, but its posted record does not establish the results of that comparison.

13. Why This Trial Matters Statistically

This trial addresses a statistical question in which the intervention is educational and the principal outcome is a patient-reported measure of activation. The endpoint is not simply a count of clinical events; it is a continuous score intended to reflect engagement in healthcare. That choice makes the meaning of the result depend on both the score contrast and its uncertainty, neither of which is reported in the registry record.

The study also measures activation over time, with baseline and follow-up assessments. Repeated observations can help describe trajectories, but they require clear specification of the time point or pattern being compared and appropriate handling of within-person correlation. A record naming several time points without an analysis description leaves that statistical target unclear.

The comparison with usual care is practically important for interpretation because usual care is described as not standardized and as typically involving technical support from an Ostomy Care Nurse. Variation in usual care can affect how precisely the intervention contrast is understood. The record does not describe actual care received across participants, so the extent of that variation is unknown.

Finally, the discrepancy between the enrollment figure and the brief summary’s planned enrollment underscores the value of transparent reporting. Clear outcome estimates, analysis details, and participant accounting are needed to distinguish a study’s aims from its findings and to assess how reliably those findings answer the clinical question. The registry record gives useful design context but does not report the primary results needed for that assessment.

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 central limitation for interpreting this trial from its registry record is that numerical results for the primary outcome are not reported. No PAM means, standard deviations, group contrasts, confidence intervals, or tests are listed. Results for the listed secondary outcome are also absent. Consequently, the record does not permit assessment of effect size, precision, or the direction of the findings.

The record names repeated assessment times but does not specify the main follow-up contrast or the method used to account for repeated measurements. It does not describe missing-data patterns, reasons for missingness, or the procedure used to handle incomplete follow-up. The primary population description requires a baseline and at least one follow-up measurement, but does not explain how participants without those data were treated.

Other analysis details are not reported in the registry record, including the statistical analysis plan, allocation procedures, multiplicity approach, and sensitivity analyses. Masking is listed as none, but the record does not describe how outcome measurement or analysis may have been protected from awareness of group assignment.

The registry lists enrollment of 216, whereas the brief summary describes a plan to enroll up to 176 subjects at three hospitals. It does not explain the discrepancy or provide site-specific enrollment. The record also does not describe actual intervention adherence, the consistency of usual care, or the completeness and definitions of adverse-event collection. These limits affect how fully the trial’s conduct and results can be assessed from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Ostomy Telehealth For Cancer Survivors — NCT02974634.
• Registry record last updated 2020-08-19; status last verified 2020-08.
• Results first posted 2020-08-11.
• 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

The registry describes a completed, randomized, parallel-group study without masking, comparing Ostomy Self-Management Training with usual care. PAM, a 100-point patient activation score, is the primary outcome, assessed at baseline, completion of the session at 5 weeks, and 6 month follow up. The summary describes a planned enrollment of up to 176 subjects, while the listed enrollment is 216; the record does not explain the discrepancy.

Numerical primary and secondary outcome results, analysis methods, and missing-data procedures are not reported in the registry record. The adverse-event fields list 0 serious and 0 other adverse events in each group, alongside death counts of 8 and 11. These entries lack causal and timing details. The record therefore documents the study’s design and intended measurements, but does not provide enough outcome information to interpret the comparative results.