Move For Your Health for Older Cancer Survivors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Move For Your Health for Older Cancer Survivors (NCT05582889), a randomized na study. The primary outcome is Time to Accrual Goal.

2. Clinical Question

The study also asks whether the intervention is associated with changes in physical activity and other participant outcomes. Secondary outcomes include chair stands, balance, daily steps, light- and moderate-intensity physical activity, sedentary activity, fatigue, and pain. These outcomes capture different aspects of function, activity, and experience, so they do not all answer the same question.

The randomized sequence compares immediate access with a wait-list period before the delayed group receives the intervention. The registry record identifies the study as a crossover trial, but it does not report enough detail to establish how each posted secondary comparison handles the crossover sequence or any possible carryover. The registered primary outcome remains time to accrual goal, and it should not be treated as a direct estimate of the intervention's effect on activity or function.

3. Trial Design

The registry record describes a randomized, single-masked, crossover study with an enrollment of 64. The study is marked completed. Its start date is 2022-11-04, and its primary completion date is 2024-03-01. The sponsor is the University of New Mexico. The intervention is behavioral, and the study is classified as phase NA.

Participants randomized to the immediate Fitbit intervention received the 12-week program first, including the tracker, app, and six coaching calls. They then crossed over and were observed for an additional 12 weeks without health coaching. Participants assigned to the delayed Fitbit intervention maintained their usual physical activity for 12 weeks before crossing over to the full 12-week intervention. This sequence means that the intervention exposure differs over time between the randomized groups.

The registry lists 32 participants in each arm for the primary outcome. It also lists 31 participants per arm for the posted step-count and light-intensity activity changes, and 32 per arm for the balance change. The reasons for these differences in the analysis counts are not reported in the registry record. The identity of the masked party, the allocation method beyond randomization, and further details of the crossover schedule are not reported in the registry record.

The primary outcome timeframe is up to 1 year. The primary outcome description calls time to accrue the study sample a feasibility measure. The record does not report a formal sample-size justification, an interim-analysis plan, or detailed statistical methods for the crossover comparisons. Those omissions limit what can be inferred about how the posted analyses were prespecified or how they account for time and sequence.

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:

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 Time to Accrual Goal, measured over up to 1-year.

The registered primary outcome is time to accrual goal, measured in months. It is defined as the number of months needed to accrue the study sample, and the registry describes it as part of assessing feasibility. In other words, this endpoint concerns recruitment progress rather than a clinical change experienced by participants.

The registry records a value of 9 months for each randomized arm, with 32 participants listed in each. These arm-level values are not presented as a usable two-arm comparison. The record does not provide an inferential estimate, confidence interval, or test for a difference in accrual time, and the comparison is identified as not estimable from the posted endpoint information.

Accrual time can help describe whether recruitment proceeded within the study's planned timeframe. It does not by itself show whether the intervention changed physical activity, balance, fatigue, pain, or other participant outcomes. Nor does an accrual result establish how acceptable or sustainable the intervention was. Those questions require their own outcome data and analysis.

The record gives a timeframe of up to 1 year for this endpoint but does not report the accrual target, the dates at which recruitment opened and closed, or the protocol's recruitment benchmark. Without those details, the 9-month values can be reported as posted, but their relation to a prespecified feasibility threshold is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count of months to accrual goal, while the available secondary comparisons are continuous outcomes reported as changes in group means. These outcome types need different summaries. For a continuous outcome, an arm's mean gives the average change, and its standard deviation describes how spread out participant changes are around that average. The arm means alone do not show how uncertain the difference between the averages is.

What does a mean difference describe?

The posted comparisons use the delayed intervention arm as the reference and report the immediate intervention arm's mean change relative to it. A mean difference is expressed in the outcome's original units: points for balance, steps per day for steps, and minutes per day for light-intensity activity. The sign indicates which arm has the higher mean change under the stated comparison direction. The estimate is an average contrast; it does not imply that every participant changed by that amount.

The recalculated confidence intervals are based on the posted group means, standard deviations, and sample sizes. In general, a confidence interval describes the range of values reasonably compatible with the data and the calculation method. A wider interval indicates less precision than a narrower one. An interval that includes zero does not rule out differences in either direction; one that lies on one side of zero indicates that the corresponding unadjusted calculation is inconsistent with a zero mean difference at the usual two-sided 0.05 level. This interpretation does not account for multiple outcome testing or unreported features of the trial analysis.

What does the p-value add?

In general, a p-value quantifies how unusual data at least as discrepant as the observed data would be under a specified null model. It is not the probability that the null hypothesis is true, the probability that the result occurred by chance, or a measure of the size of an effect. The posted p-values for these secondary outcomes are unadjusted recalculations. They do not account for the number of outcomes considered, and the registry does not report a multiplicity adjustment.

The registry's secondary outcome summaries report a standard deviation for each arm. A pooled standard deviation can be used in a simple standardized comparison, expressing a mean difference relative to the overall within-group variation. This can help describe the magnitude of a contrast on a scale that is less tied to the original units. It does not substitute for the original-unit estimate or resolve uncertainty about the crossover analysis. The record does not report such standardized estimates as part of a sponsor analysis.

Why does over-dispersion matter?

In general, over-dispersion occurs when the observed variability in data is greater than a model assumes. For a continuous outcome, greater variability makes the mean difference less precisely estimated, all else being equal. The reported standard deviations for the step changes are large relative to their group means, which signals substantial spread in participant changes. A mean can still be calculated, but it may not describe the experience of a typical participant well if individual changes vary widely. The record does not report a distributional assessment or an alternative analysis intended to address skewness or outlying observations.

The posted secondary comparisons are simple unadjusted recalculations from summary statistics, rather than reported analyses. They treat the groups as independent for the calculation and do not account for the crossover structure. In a crossover trial, outcomes can depend on treatment period, sequence, or persistence of an earlier intervention effect. An analysis may need to represent those features, depending on the design and data. The registry record does not report how such features were addressed, so these recalculations should not be interpreted as a substitute for a trial-specific crossover analysis.

How should the planning illustrations be read?

The planning illustrations use the observed effect as a starting point and give hypothetical participants per arm for 80% or 90% power. The stated assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation; the targeted effect is a stated fraction of the observed effect. They are planning illustrations only. They are not observed power, do not establish the study's original design assumptions, and are not evidence that a future study would reproduce the pilot effect. Smaller targeted effects require larger hypothetical groups under the stated approach. The registry record does not report the trial's own sample-size justification.

The primary accrual outcome is not converted into the same kind of two-arm mean comparison. It is a count-type outcome, and the posted values do not support an estimable contrast from the registry information. The record explicitly indicates that a two-arm comparison is not available for this endpoint. It would not be appropriate to infer a test or confidence interval that was not reported.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple secondary outcomes and reports no sponsor analyses in the information summarized for these results. The recalculated comparisons for the continuous secondary outcomes are unadjusted. The record does not report a multiplicity plan, such as a hierarchy of confirmatory outcomes or an adjustment to account for testing several outcomes. In general, examining multiple outcomes without adjustment increases the chance of at least one apparently unusual result when all effects are absent. This makes isolated secondary p-values less conclusive than a prespecified primary analysis.

Missing-data methods are not reported in the registry record. The posted arm counts vary across the primary outcome and the secondary measures, but the reason for each count is not given. The record does not state whether participants with missing measurements were excluded, whether missing values were imputed, or whether sensitivity analyses were performed. It also does not provide enough information to determine whether the analyzed participants represent an intention-to-treat population or another analysis population.

The registry identifies a crossover model, but the posted summary comparisons do not explain how the crossover sequence was incorporated. Period effects, sequence effects, and carryover are not discussed in the reported analyses. These are relevant methodological considerations in general for crossover studies, because measurements can depend on when an intervention is received and on whether an earlier intervention has effects that persist. The registry record does not report the analysis methods used to assess these issues.

The absence of these details is not evidence that a particular method was or was not used outside the registry record. It means that readers cannot evaluate those decisions from the reported information. The results should therefore be read as posted summaries and unadjusted recalculations, not as a complete account of the prespecified analysis strategy.

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.

Most frequent non-serious adverse event terms

The adverse-event figures list no serious adverse events among the 32 participants at risk in either arm, and no deaths in either arm. For other adverse events, the immediate intervention arm has zero affected participants among 32 at risk, while the delayed intervention arm has one affected participant among 32 at risk. The record does not list serious adverse-event terms.

These counts are descriptive. With few or no recorded events, the figures provide limited information about how often uncommon events might occur, and they do not establish that an event could not occur. The registry record does not provide event descriptions, severity details for the other adverse event, attribution to the intervention, or a fuller account of how events were collected. The comparison should not be treated as a formal safety analysis or as evidence of causation.

Because the trial uses a crossover sequence, participants' intervention exposure changes over time. The adverse-event figures are organized by arm, but the registry information does not explain the period of observation or whether events were attributed to a particular intervention period. That missing context limits interpretation of the counts as intervention-specific rates.

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

The posted primary result describes recruitment feasibility: the registry records 9 months to accrue the study sample in each arm. It does not provide an estimable between-arm contrast or a recruitment benchmark against which to judge that duration. The primary result therefore does not establish whether a prespecified accrual target was met, and it does not answer whether physical activity or function changed.

The secondary summaries show average changes in selected outcomes over 12 weeks. The unadjusted recalculations indicate a positive mean difference for daily steps and light-intensity activity, while the balance interval includes zero. These estimates describe group averages and remain uncertain. They are not equivalent to individual-level responses, and the registry does not report analyses that adjust for the trial's crossover structure or for testing multiple secondary outcomes.

The results do not establish a durable effect beyond the reported outcome timeframe, nor do they show whether changes persisted after coaching or tracker use. The delayed arm's later receipt of the intervention is part of the study design, but the registry summary does not provide a complete period-by-period analysis. The results also do not establish how participants with missing measurements differed from those with posted data.

In general, a pilot study can offer information about feasibility and help identify outcomes for further study. Its observed effects can be imprecise and may not be stable estimates for planning a larger trial. The posted planning illustrations are hypothetical calculations based on observed effects, not evidence of observed power or a guarantee of the sample size needed in another study. The registry record does not report the original sample-size justification.

These findings should be read as a limited statistical description of the posted record. They neither prove nor disprove a clinical benefit. The record does not provide enough information to resolve all questions about analysis populations, missing data, crossover effects, multiplicity, or the clinical importance of the observed changes.

13. Why This Trial Matters Statistically

This study is statistically informative because its primary outcome is explicitly a feasibility measure. Accrual time addresses whether recruitment can proceed, a different question from whether an intervention changes a health or activity outcome. Keeping those questions distinct prevents a recruitment result from being mistaken for evidence about participant-level effects.

The randomized crossover design also highlights the importance of aligning the analysis with the timing of intervention exposure. A simple comparison of group summaries can be useful for describing posted data, but it does not by itself show how a full crossover analysis should account for periods, sequence, or carryover. The registry record does not report those analytical details, making transparent interpretation especially important.

The secondary outcomes span objective measures, physical-function tests, and self-reported symptoms. This breadth can help describe different dimensions of a pilot intervention, but it also raises the importance of distinguishing exploratory findings from confirmatory evidence. Multiple unadjusted comparisons should not be read as a collection of independent confirmations.

Finally, the planning illustrations show why pilot effect estimates need care when used to plan later research. The number of participants needed depends on the effect a future study is intended to detect, along with the assumptions used in the calculation. The illustrations are not the study's original design rationale and are not observed power. Separating these purposes helps avoid overstating what a small completed pilot can establish.

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.

Several trial-specific limitations affect interpretation. The registry identifies the study as a crossover trial, but the reported comparisons do not explain whether they use only the randomized initial period or combine observations across periods. Period, sequence, and carryover methods are not reported in the registry record. Consequently, the recalculated group contrasts cannot be assumed to represent a complete crossover treatment-effect analysis.

The primary outcome is reported as 9 months in each arm, but no inferential comparison is available and no recruitment benchmark is reported. The value therefore has limited context for judging feasibility. The registry also does not report the accrual target or a detailed recruitment schedule.

The numerical secondary comparisons are unadjusted recalculations, and the registry record does not report a multiplicity strategy or a hierarchy for interpreting the many secondary outcomes. The reasons for different analysis counts across outcomes are not reported, and missing-data methods and analysis populations are not described. These gaps make it difficult to judge the potential influence of incomplete observations.

For safety, the recorded event counts are sparse and lack details about event type, attribution, and observation period. They cannot provide a broad account of potential risks. For the continuous outcomes, the summaries give group means and standard deviations, but the record does not report distribution checks, participant-level data, or sensitivity analyses. Those omissions limit assessment of variability and the robustness of the recalculated estimates.

The planning illustrations use observed pilot effects and stated assumptions; they do not replace the unreported original sample-size justification. The record also does not report whether the reported outcome timeframes and analysis choices were set before data collection. These limitations do not invalidate the posted summaries, but they constrain how confidently they can be generalized or interpreted.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Move For Your Health for Older Cancer Survivors — NCT05582889.
• Registry record last updated 2025-11-10; status last verified 2025-10.
• Results first posted 2025-11-10.
• 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 record describes a completed randomized, single-masked crossover pilot study of the Move for Your Health Fitbit intervention in older cancer survivors. Enrollment was 64, with 32 participants assigned to each arm. The immediate group received the 12-week tracker, app, and coaching program first; the delayed group maintained usual activity for 12 weeks before receiving the intervention.

The primary endpoint is time to accrual goal, with 9 months recorded in each arm and no estimable two-arm comparison. Secondary measures include changes in physical function, activity, sedentary behavior, fatigue, and pain. Unadjusted recalculations from posted summaries estimate positive differences for daily steps and light-intensity activity; the balance interval includes zero. The registry record does not report trial-specific analyses, multiplicity methods, missing-data methods, or a detailed crossover analysis plan. Serious adverse events and deaths are recorded as zero in both arms; one other adverse event is recorded in the delayed arm.