Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors (NCT03837496), a randomized na study. The primary outcome is Feasibility and Acceptability.

2. Clinical Question

3. Trial Design

The trial is identified as a randomized, single-masked, parallel-group study. It is titled a pilot feasibility trial and compares STRIDE with Medication Monitoring Control. The registry lists an enrollment of 100 participants. The study began on 2019-10-28, had a primary completion date of 2021-08-17, and is recorded as completed. The phase is listed as not applicable.

STRIDE is described as a small-group cognitive-behavioral program for breast cancer survivors receiving hormonal therapy. The intervention description specifies six weekly one-hour sessions, delivered virtually in small groups with a trained clinician. It allows individual delivery in the rare instance when scheduling does not allow a group and a participant is approaching the 12-week assessment window. The study description also says the program includes two 15-minute check-in phone calls later in the study. The listed STRIDE Run-In description specifies five weekly one-hour sessions, delivered virtually or in person in small groups, and two 15-minute check-in phone calls.

The control is medication monitoring plus standard care. The record describes medication storage in a study-provided bottle and questionnaires at enrollment, 12 weeks, and 24 weeks after enrollment. The outcomes include medication adherence over the 24-week study period, self-reported adherence, satisfaction with adjuvant endocrine therapy, and symptom distress assessed from baseline to 12 weeks. The primary outcome instead focuses on feasibility and acceptability at 12 weeks.

The registry record does not report the randomization procedure, allocation concealment, or the masking details beyond identifying the study as single-masked. It also does not report a protocol-based justification for the enrollment target 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

Analysis population for the primary outcome, as defined in the registry: The analysis populations are as follows. Feasibility: Enrollment - 141 eligible participants were approached and 100 participants enrolled (70.9%). For the remainder of the feasibility analyses, the analysis population will utilize a denominator of 100 participants enrolled to the STRIDE study. For the acceptability analysis, the analysis population will utilize a denominator of the 43 participants who completed at least four out of the six STRIDE sessions.

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 Feasibility and Acceptability, measured over 12 weeks.

The primary endpoint is feasibility and acceptability, assessed using participant counts and rates rather than a single clinical symptom score. Feasibility is described through recruitment, follow-up assessment completion, and attendance. The stated recruitment criterion is an enrollment rate > 50%. Retention is defined using follow-up assessment completion, with a target > 70% of participants who complete baseline. The attendance criterion is stated as at least 70% of participants completing at least 4 of 6 sessions [67%].

Acceptability is assessed using scores on the Client Satisfaction Questionnaire (CSQ). The program is to be deemed acceptable if >75% of participants report average satisfaction scores greater than the CSQ midpoint. The CSQ is described as a four-point Likert scale, with higher scores indicating higher satisfaction.

These measures are useful in a pilot because they address whether recruitment, participation, follow-up, and satisfaction meet prespecified practical benchmarks. They do not, by themselves, estimate the program's effect on symptoms or medication adherence. The record reports that 141 eligible participants were approached and 100 enrolled, with an enrollment rate of 70.9%. The other feasibility and acceptability results are not reported in the registry record, so it is not possible to determine from these figures whether the follow-up, attendance, or satisfaction criteria were met.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization mean in this study?

Randomization assigns participants to study groups using a chance-based process. In general, this helps reduce systematic differences between groups at assignment, although it cannot guarantee that groups will be identical, especially in a pilot study. The registry identifies this trial as randomized and parallel-group, with STRIDE and Medication Monitoring Control listed as the interventions. The specific sequence-generation and allocation-concealment methods are not reported in the registry record. The record calls the study single-masked but does not specify who was masked or how masking was maintained.

What is the role of a feasibility endpoint?

A feasibility endpoint evaluates whether key study processes reach practical targets. Recruitment, follow-up completion, attendance, and participant satisfaction answer different questions. A recruitment rate describes entry into the study among eligible people approached. Retention concerns whether participants complete follow-up assessments. Attendance indicates participation in the intervention sessions. Satisfaction reflects participants' reported experience. These measures are not interchangeable, and success on one does not establish success on the others.

For this trial, the registry states a recruitment target of > 50%, a follow-up assessment completion target of > 70% of participants completing baseline, an attendance target involving at least 70% of participants completing at least 4 of 6 sessions [67%], and an acceptability target requiring >75% of participants to report average CSQ satisfaction scores greater than the scale midpoint. The enrollment result can be compared with the recruitment criterion directly because both are reported. The other planned criteria cannot be assessed from the results because their observed values are not reported in the registry record.

Why distinguish a criterion from an observed result?

A threshold is a rule for judging a measure, not a result. The stated threshold says what the investigators planned to regard as an acceptable level. It does not show that the study reached that level. Reading a benchmark alongside the observed enrollment rate is informative for recruitment; applying the same logic to retention, attendance, or satisfaction requires observed results for those measures.

How should Likert-scale satisfaction be understood?

The CSQ is described as a four-point Likert scale with higher scores indicating higher satisfaction. A Likert scale records ordered responses, so higher categories represent more satisfaction according to the instrument. The registry's acceptability rule is based on the proportion of participants whose average satisfaction scores are above the scale midpoint. The result needed to assess that rule is not reported in the registry record. The scale description alone cannot establish participants' satisfaction.

What does a confidence interval contribute?

In general, a confidence interval accompanies an estimate and communicates its statistical precision under the chosen method. A narrower interval indicates greater precision than a wider interval, all else equal. An interval also helps readers assess which effect sizes remain compatible with the data. It does not remove limitations in measurement, trial conduct, or generalizability. No confidence interval for the primary feasibility measures or secondary outcomes is reported in the registry record.

What does a p-value contribute?

In general, a p-value evaluates the compatibility of observed data with a specified null model, conditional on the model and analysis assumptions. It is not the probability that the null hypothesis is true and is not a measure of effect size. For a clinical comparison, estimates and their uncertainty are needed to understand magnitude and precision alongside any test result. The registry information does not report p-values for the primary or secondary outcomes.

Why can over-dispersion matter?

In general, over-dispersion occurs when count data vary more than a statistical model assumes. If a model assumes less variability than is present, standard errors and tests can be misleading. Analysts may use methods that account for extra variation when appropriate. The primary endpoint in this record is described as participant counts and feasibility rates, but the registry information does not identify a count model or report an over-dispersion assessment. It would therefore be inappropriate to infer that such a method was or was not used.

What can planning calculations tell readers?

In general, sample-size planning illustrations show how design assumptions relate to the amount of information needed to detect a specified effect under an assumed analysis. They are not observed trial outcomes and do not establish the probability that a particular trial result is correct. The record's planning description refers to a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as a fraction of an observed effect. It also distinguishes participant-per-arm displays from total-event displays for time-to-event settings. These assumptions are not evidence of the trial's own design justification. The registry record does not report the trial's sample-size justification or establish that a planning illustration was the protocol's design basis.

Because the primary outcome includes several feasibility components and the secondary outcomes cover multiple measures and time points, a complete statistical interpretation would require the analysis plan and the results for each measure. Those details, including the handling of missing observations and any interim analyses, are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The trial has several outcome measures. The primary feasibility and acceptability outcome includes recruitment, retention, session attendance, and satisfaction criteria. Secondary outcomes concern medication adherence over the study period, self-reported adherence from baseline to 12 weeks, satisfaction with adjuvant endocrine therapy from baseline to 12 weeks, and symptom distress from baseline to 12 weeks. Considering multiple measures can raise multiplicity concerns: repeated testing can increase the chance of at least one apparently notable result when all outcomes are examined. In general, a statistical plan may specify a primary comparison, a hierarchy, or an adjustment approach. Any multiplicity strategy for this trial is not reported in the registry record.

The record reports an analysis population of 100 enrolled participants for the remainder of feasibility analyses. It separately describes retention relative to participants who complete baseline. It does not report the analysis populations used for the secondary outcomes, the treatment of participants who did not complete follow-up, or whether analyses followed an intention-to-treat principle. Missing-data methods and the extent of missing outcome data are not reported in the registry record.

These omissions limit interpretation. Without a reported analysis population and missing-data approach, readers cannot determine how incomplete observations may have affected estimates. Without a reported multiplicity plan and complete outcome results, readers cannot assess how the different measures were handled together. The registry information also does not report interim analyses or a detailed statistical analysis plan.

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.

The posted serious adverse event figures list 50 participants at risk in the STRIDE group and 50 in Medication Monitoring Control. For each group, the registry reports 0 participants affected by serious adverse events, 0 participants affected by other adverse events, and 0 deaths. No serious adverse event terms are listed.

These figures describe the adverse event counts recorded in the registry. They should not be interpreted as proof that no adverse events occurred in any broader sense, or as evidence that the groups have identical safety profiles. The displayed counts do not provide event-level descriptions, severity detail beyond the serious-versus-other categories, timing, or a statistical comparison. The registry information does not report additional safety analyses.

In general, a count of zero means that no events of the specified category were recorded for the listed group in the posted data. It does not establish that the underlying risk is zero. Safety interpretation also depends on how events were solicited, defined, followed, and reported; those details are not reported in the registry record. The figures should be read as the posted counts, without extending them into a conclusion about comparative safety.

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

The reported enrollment result gives a concrete answer to one part of the pilot question: 100 participants enrolled from 141 eligible people approached, and the registry reports an enrollment rate of 70.9%. This is above the recruitment benchmark of > 50% stated for the study. It indicates that the recruitment criterion, as reported, was met.

That finding does not establish that all feasibility criteria were met. The planned measures also include follow-up assessment completion, intervention attendance, and satisfaction. Their criteria are stated, but their observed results are not reported in the registry record. It is therefore not possible to judge overall feasibility and acceptability from recruitment alone.

The result also does not show whether STRIDE improved symptoms, reduced distress, or changed medication adherence relative to Medication Monitoring Control. Those topics appear among the trial's aims and secondary outcomes, but their numerical results and uncertainty estimates are not reported. A feasibility result is not a substitute for a between-group estimate of a clinical or behavioral outcome.

In general, a randomized comparison can estimate differences between groups when outcome data and the relevant analysis are reported. The registry identifies a randomized parallel-group design, but the information does not provide outcome estimates, confidence intervals, or p-values for the secondary measures. No conclusion about the magnitude or precision of an intervention effect can be made from the enrollment data.

The study's completed status means the record identifies it as completed; it does not imply that every planned outcome result is available in the information. The appropriate reading is narrow: recruitment is reported and can be compared with its stated benchmark, while the remaining feasibility and intervention-effect questions remain unresolved in the registry record.

13. Why This Trial Matters Statistically

Pilot feasibility trials address an important statistical issue: before interpreting a larger efficacy comparison, researchers need to know whether recruitment, intervention delivery, follow-up, and outcome measurement are workable. STRIDE's primary outcome reflects that purpose by setting criteria for recruitment, retention, attendance, and satisfaction rather than relying only on a symptom or adherence endpoint.

The enrollment figure is particularly interpretable because the record reports both the number of eligible people approached and the number enrolled, as well as the enrollment rate. That allows the recruitment result to be compared with the prespecified recruitment benchmark. In contrast, the other feasibility components cannot be judged without their observed results. This illustrates why reporting each component matters: a single overall label such as feasible can conceal different performance across recruitment, attendance, follow-up, and acceptability.

The trial also includes outcomes relevant to adherence, treatment satisfaction, and symptom distress. Those measures could inform the design of a future study, but estimates and uncertainty are necessary to understand how much information the pilot provides about them. A pilot's enrollment count does not establish the precision of a treatment-effect estimate, nor does it establish that a larger definitive trial would have a particular result.

More broadly, the record shows how statistical interpretation depends on clear separation of goals. Feasibility benchmarks describe operational targets; clinical comparisons describe differences in participant outcomes. The available recruitment result speaks to the first category only. Complete reporting of the other planned measures, analysis populations, missing-data handling, and statistical methods would be needed to evaluate the broader set of questions.

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 the primary outcome is that only the recruitment result is reported in the information. Observed retention, attendance, and satisfaction results are not reported in the registry record, although the criteria for assessing them are given. This prevents an assessment of the full feasibility and acceptability endpoint.

The record lists secondary outcomes for adherence, treatment satisfaction, and symptom distress, but does not report numerical group results or between-group estimates in the information. Confidence intervals and p-values are also not reported. As a result, the direction, size, and precision of any differences cannot be evaluated from these registry entries.

Methods that would help assess internal validity and reproducibility are not reported in the registry record. These include the randomization procedure, allocation concealment, who was masked, detailed analysis methods, handling of missing data, and any multiplicity strategy. Interim analyses and a sample-size justification are also not reported. The planning assumptions described in the record should not be treated as the trial's own design justification.

The intervention is described as primarily group-based and virtual, with individual delivery possible in a scheduling circumstance. Such flexibility is relevant to understanding how the intervention was implemented, but the registry information does not report how often each delivery format was used or whether implementation differed across participants. No additional inference about adherence to the intervention protocol can be made from the description alone.

Finally, enrollment and the listed adverse event counts do not resolve the clinical outcomes. The trial's completed status and the recruitment result are not substitutes for full outcome reporting. These limitations apply to interpretation of the registry information, rather than establishing that unreported analyses were not conducted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors — NCT03837496.
• Registry record last updated 2022-11-18; status last verified 2022-11.
• Results first posted 2022-11-18.
• 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

NCT03837496 is a completed randomized, single-masked, parallel-group pilot feasibility trial of STRIDE versus Medication Monitoring Control among breast cancer survivors taking hormonal therapy. The study began on 2019-10-28 and had a primary completion date of 2021-08-17. The record lists enrollment of 100.

The primary outcome is feasibility and acceptability at 12 weeks, assessed through recruitment, retention, attendance, and satisfaction criteria. The registry reports that 141 eligible participants were approached and 100 enrolled, with an enrollment rate of 70.9%. This exceeds the stated recruitment criterion of > 50%. Observed results for the other feasibility components are not reported in the registry record.

Secondary outcomes address medication adherence, satisfaction with adjuvant endocrine therapy, and symptom distress. Numerical comparative results and detailed statistical methods for those outcomes are not reported in the information. The adverse event entries list 0 serious events, 0 other events, and 0 deaths in each group.