Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer (NCT03364673), a na na study. The primary outcome is Feasibility of the Accelerometer + Social Support + Gamification.

2. Clinical Question

This question is about whether participants complete an intervention, not about estimating a treatment effect against an untreated or alternative-treatment group. The record names changes in daily steps from baseline to 12 weeks and from baseline to 24 weeks as secondary outcomes. The design and information available in the registry record do not establish whether changes in those outcomes were caused by the intervention. The feasibility question is therefore best read as a description of participation and completion within this pilot, rather than as evidence of comparative effectiveness.

3. Trial Design

The registry describes a completed, single-group pilot study, with an enrollment of 29 and no randomized allocation. The study was conducted by Dana-Farber Cancer Institute. Its listed start date is 2018-07-20, and its primary completion date is 2019-10-31. The phase is listed as NA. Masking is listed as none, which is consistent with the registry’s description of a behavioral intervention in which participants received a fitness tracker and social incentives.

The intervention combined a fitness tracker with a social-incentive component delivered through Way to Health. The described approach asked each participant to enroll with a teammate, collaborate on a daily step goal, receive feedback about goal achievement, and receive a social incentive. These details describe the planned intervention experience; they do not establish how many participants used each component or how consistently they engaged with it.

The registry’s stated study purpose was to test whether wearable fitness trackers with a social incentive, delivered through a game-based mobile health intervention, increase physical activity and quality of life in ovarian cancer survivors. The primary outcome is framed as feasibility, while the named secondary outcomes concern change in daily steps at 12 weeks and 24 weeks. The record lists five outcome measures overall, but does not give further outcome names or results in the information available for this analysis.

With no separate control group, observed changes over time would not by themselves distinguish an intervention effect from other explanations, such as changes that occur over time or differences in who contributes outcome data. The registry record does not report the statistical analysis plan, the number completing follow-up, or the results needed to assess the stated feasibility criterion. Completion status for the study is recorded as completed, but that status is not the same as evidence that participants met the intervention-completion target.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants who initially consented to the 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 Feasibility of the Accelerometer + Social Support + Gamification, measured over 1 year pilot.

The primary endpoint is a count of participants, with the stated feasibility definition expressed as a percentage: at least 60% of patients who participate in the pilot study complete the 24-week intervention. The population for this outcome is described as participants who initially consented to the study. The endpoint therefore concerns the practical delivery and completion of the intervention over its planned period. It is not a measure of how much daily activity changed, and it is not a direct comparison of outcomes between intervention and control groups.

Feasibility endpoints are used in pilot research to assess whether an intervention can be implemented and whether participants remain engaged through the planned activities. A completion threshold gives a prespecified benchmark for judging whether the pilot meets its operational goal. That benchmark can be useful when considering whether further study is practicable, but it does not establish clinical benefit or show that the intervention caused a change in physical activity or quality of life.

The registry record does not report the observed number or proportion of participants who completed the 24-week intervention. It therefore does not establish whether the stated threshold was reached. Nor does the record describe how completion was defined operationally beyond the stated intervention period, or how missing completion information was handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods are useful only when they match the question and the structure of the data. This study’s primary question is whether a specified share of participants completed a 24-week intervention. Its named secondary outcomes concern change in daily steps from baseline to follow-up. These questions involve different types of outcomes: completion is a yes-or-no status for each participant, while step-count change is a quantitative measurement observed over time. The registry record does not report the analyses used for either type.

What a feasibility proportion represents

In general, a feasibility proportion is formed by identifying participants who meet the completion definition and relating that count to the specified population. The registry defines the relevant population as participants who initially consented and sets a benchmark of at least 60% completing the 24-week intervention. A proportion describes the observed completion experience in the study population. Its precision depends in part on how many people contribute usable completion information and on the number who meet the definition. The registry record does not report the completion count, the observed proportion, or an interval expressing its uncertainty.

A threshold and an observed result answer different questions. The threshold is the criterion set out in the outcome definition; the observed result would show whether the participants’ completion experience met that criterion. A threshold alone cannot establish success. Nor can the enrollment total stand in for the completion count: the endpoint concerns participants completing the intervention, while enrollment describes those entered into the study.

What uncertainty intervals would add

In general, a confidence interval gives a range of values compatible with the data under a specified statistical procedure. For a feasibility proportion, an interval would help readers assess how precisely the study estimates completion in a broader population similar to the one studied. A point estimate near a benchmark can have substantial uncertainty, especially when the study is small; an interval makes that uncertainty visible rather than treating the observed proportion as exact. No confidence interval or other uncertainty estimate for feasibility is reported in the registry record.

A confidence interval does not remove design limitations. It describes statistical uncertainty under the analysis assumptions, not uncertainty from unmeasured differences, selection, or incomplete follow-up. In this single-group study, an interval around completion would characterize feasibility, but it would not create a control group or establish a causal effect on activity or quality of life.

How change in daily steps is usually analyzed

General methods for repeated measurements can compare follow-up values with baseline values within participants. A simple change score is one way to describe that contrast. More elaborate approaches can use measurements at multiple time points and account for the fact that measurements from the same participant are related. The appropriate method depends on the available observations, the outcome distribution, missingness, and the analysis question. The registry identifies step-change outcomes at 12 weeks and 24 weeks but does not report the chosen model, estimates, variability measures, or tests.

Daily step counts can vary considerably between people and may be more dispersed than a simple model assumes. In general, over-dispersion means that observed variation exceeds what a model’s assumed distribution allows. If present, it can make standard errors and uncertainty intervals too small when not handled appropriately. Whether over-dispersion was assessed or addressed in this study is not reported in the registry record. It would not be appropriate to assume a particular distribution or analysis model from the outcome name alone.

Why the design matters for inference

In general, random allocation to intervention and comparator groups can help balance factors that influence outcomes, whereas a single-group before-and-after design has no concurrent group to represent what might have happened without the intervention. Here, allocation is listed as NA and the model as single group; there is no like-for-like control comparison. A change in steps, if reported, could therefore be described over time but would not alone isolate the effect of the tracker, social incentive, game-based delivery, or teammate involvement.

Masking is listed as none. In general, lack of masking can matter when outcomes or behaviors are influenced by awareness of the intervention. The record describes use of a tracker and feedback, but does not report whether step data were collected objectively at all time points, how device non-use was handled, or whether outcome assessors were involved. Those operational details are not reported in the registry record.

Planning calculations versus observed evidence

In general, sample-size planning uses assumptions about the outcome, expected effect, variability, statistical error rates, and design. Planning illustrations are hypothetical calculations, not trial results and not observed power. A calculation framed around two equally allocated arms would not describe the actual single-group design as recorded. The registry record does not report a trial-specific sample-size justification or the assumptions used by investigators to plan enrollment. No planning illustration can substitute for the missing completion and outcome estimates.

These general concepts clarify what statistical reporting would contribute: an observed endpoint value, a suitable uncertainty estimate, a transparent analysis population, and a description of how missing data were treated. Since the registry record does not report the analyses or their results, no estimate of intervention effect, precision, or achieved statistical power can be drawn from it.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists five outcome measures, names daily-step changes from baseline to 12 weeks and from baseline to 24 weeks as secondary outcomes, and records zero analyses. It does not report a statistical analysis plan identifying which outcomes were confirmatory, how outcome priority was determined, or whether any adjustment for multiple comparisons was planned. When multiple outcomes are examined, the chance of at least one apparently unusual result can increase; in general, multiplicity procedures can address that issue, but no such procedure is reported.

Missing-data methods are also not reported in the registry record. The record does not state how incomplete step measurements, unavailable follow-up, or unknown intervention-completion status were handled. It does not indicate whether missing observations were excluded, imputed, or addressed through another approach. Without these details, the consequences of incomplete follow-up for the endpoint estimates cannot be assessed.

The analysis population is not reported in the registry record. The endpoint description refers to participants who initially consented, but that does not by itself specify how participants with incomplete data were treated in an analysis. The record also does not say whether analyses followed an intention-to-treat approach or used another population definition. No such approach should be inferred from the study’s enrollment or completed status.

In general, transparent reporting of outcome hierarchy, multiplicity handling, missing-data assumptions, and analysis populations helps readers understand how estimates were produced and how robust they may be. Because these elements are absent, the registry record does not support a detailed assessment of analysis choices or their potential influence on results.

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 the Fitness Tracker + Social Incentive Intervention group, the registry records 29 participants at risk for serious adverse events and zero participants affected. It also records 29 at risk for other adverse events and zero affected, with zero deaths. These are the reported counts for the intervention group.

Zero recorded events should be read as a statement about the registry entries, not as proof that the intervention carries no risk. The record does not report the observation window, the method used to collect adverse-event information, or definitions for the event categories. It also does not provide a comparison group, so these counts cannot be contrasted with an alternative intervention or usual care. The reported counts therefore describe the safety information entered in the registry; they do not establish a comparative safety effect or rule out unrecorded events.

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

The study record describes a behavioral pilot intended to explore a fitness tracker and social incentive for ovarian cancer survivors. It gives a concrete feasibility criterion: at least 60% of participating patients completing the 24-week intervention. That criterion focuses on whether participants can remain engaged with the program over its planned duration. The registry record does not report whether the criterion was met, because it does not report the completion count or observed proportion.

The study’s stated purpose also concerns physical activity and quality of life. The named secondary outcomes are changes in daily steps from baseline to 12 weeks and from baseline to 24 weeks. No estimates for those changes are reported in the registry record. As a result, the record does not establish the direction, size, or precision of any change in daily steps. It does not provide a quality-of-life result either.

Even if a change from baseline had been reported, a single-group study cannot by itself show what would have happened over the same period without the intervention. The design has no separate comparison group, so a before-and-after difference would not isolate the intervention from other influences. The teammate component, goal setting, feedback, tracker, and incentive are delivered together in the described program; the design also does not separate the contribution of each component.

The adverse-event counts are reassuring only in the narrow sense that the registry records zero affected participants in the listed categories. They do not show that no event occurred outside the recorded information, and they do not provide a comparative safety assessment. In short, the registry record documents a pilot design and intended questions, but does not report the outcome evidence needed to conclude whether the feasibility benchmark was achieved or whether activity or quality of life changed.

13. Why This Trial Matters Statistically

Feasibility is an important statistical question when an intervention requires sustained participant engagement. A program can be described in detail and its outcomes can be specified, yet the practical value of a larger evaluation depends partly on whether participants can take part through the intended follow-up. This study makes that issue explicit through a completion benchmark for a 24-week intervention.

The design also illustrates why outcome type and study structure must guide interpretation. A completion endpoint can describe participation in a single group. Change in daily steps is a different question, and a single-group comparison over time cannot provide the same causal evidence as a randomized comparison with a control group. Recognizing that distinction helps keep feasibility evidence separate from evidence about effects.

The registry record is useful for identifying the intervention components, the stated endpoint, and the planned measurement times. At the same time, its lack of reported analyses and results limits what can be learned about the observed participant experience. This is a statistical reporting issue as well as a design issue: without endpoint values and uncertainty, the intended questions remain unanswered in the record.

For clinical researchers and biostatisticians, the example emphasizes the importance of reporting participant flow, completion counts, outcome estimates, uncertainty, analysis populations, and missing-data handling. Those details are necessary to interpret a feasibility threshold and any activity changes. The study’s single-group structure remains central: complete reporting could characterize pilot outcomes more clearly, but could not turn the design into a controlled causal comparison.

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 principal limitation is that the registry record does not report results for the primary feasibility endpoint or the named secondary outcomes. The completion threshold is stated, but the number and proportion who completed the intervention are not reported. Step-change estimates and their precision are also absent. Although the record mentions quality of life in the study purpose, a quality-of-life outcome result is not reported.

The single-group design has no concurrent comparator, and allocation is listed as NA. Consequently, the design does not support a like-for-like comparison or isolate the effect of the intervention from other changes over time. The intervention combines a fitness tracker, social incentives, teammate collaboration, goal setting, and feedback, so the contribution of an individual component cannot be distinguished from the registry description.

Enrollment is recorded as 29, but the registry does not report participant flow, follow-up completeness, or the number with usable data at each outcome time. Handling of missing data and the analysis population are not reported in the registry record. The statistical analysis plan, multiplicity approach, and trial-specific sample-size justification are also not reported.

Finally, the safety entries lack a reported observation period and further detail about event ascertainment. The zero counts should therefore be interpreted as recorded counts rather than a complete characterization of risk. These limitations concern the information and design documented in the registry record; they do not establish what the investigators may have found in analyses that are not reported there.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Stepping Into Survivorship: Harnessing Behavioral Economics to Improve Quality of Life in Ovarian Cancer — NCT03364673.
• Registry record last updated 2023-10-13; status last verified 2023-10.
• Results first posted 2021-09-17.
• 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

This completed, single-group pilot evaluated a fitness tracker and social-incentive intervention for ovarian cancer survivors. Enrollment was 29. The intervention description includes teammate enrollment, collaborative daily step goals, feedback, and a social incentive. The primary outcome is feasibility, defined as at least 60% of participating patients completing the 24-week intervention. Named secondary outcomes concern daily-step changes from baseline to 12 weeks and 24 weeks.

The registry record does not report the primary endpoint result, secondary outcome estimates, or statistical analyses. It lists five outcome measures and zero analyses. It also does not report missing-data methods, the analysis population, multiplicity handling, or a trial-specific sample-size justification. For the intervention group, the registry records zero serious adverse events, zero other adverse events, and zero deaths among 29 participants at risk in each category.