Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment (NCT05258058), a na na study. The primary outcome is MAAT-G Feasibility Completion Rate.

2. Clinical Question

This is a feasibility question rather than a randomized estimate of comparative efficacy. The intervention is tailored for older adults and is described as cognitive behavioral therapy-based. The broader motivation stated in the record is that cancer-related cognitive dysfunction can affect functional independence and quality of life. Those statements explain the rationale; they are not results of this study.

The registry lists 12 participants as enrollment. That number describes enrollment, not how many completed the study or contributed to each outcome. The number included in the completion-rate analysis, and the rules used to define completion, are not reported in the registry record. Without those details and the primary outcome result, the central feasibility estimate cannot be interpreted from the record.

3. Trial Design

The registry identifies this as a completed, single-group behavioral intervention study, with allocation recorded as NA and masking listed as none. Enrollment is 12. The official title calls it Phase I, while the phase field is recorded as NA. The listed intervention is Memory and Adaptation Training-Geriatrics; the arm description calls it MAAT-G Workshops and participant workbook use, with 8 workshops.

The primary completion date is 2023-07-20, and the start date is 2021-12-10. The primary outcome timeframe is 10 Weeks. These dates and the timeframe describe the registry record; they do not establish how long each participant took to complete the intervention, when outcome assessments occurred, or whether the planned schedule was followed. Those details are not reported in the registry record.

A single-group design can describe whether participants engaged with an intervention and what outcomes were observed during the study. It does not create a like-for-like comparison with usual care or another intervention. Because there is no concurrent control group, changes over time cannot be separated from other influences using a between-group contrast. The registry’s allocation entry and the design description do not support interpreting the study as randomized.

The registry lists secondary outcomes concerning whether participants described at least one MAAT-G skill, change in cognitive function using pre-post Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) assessments, and mean usability. Their individual results and analysis details are not reported in the registry record. No protocol-level detail about recruitment procedures, intervention fidelity, or follow-up beyond the listed timeframe is 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.

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 MAAT-G Feasibility Completion Rate, measured over 10 Weeks.

The primary endpoint is MAAT-G feasibility completion rate, described as the study completion rate in older cancer survivors with mild cognitive impairment. It is associated with a 10 Weeks timeframe and a unit of participants. The registry record does not report the number who completed the study, the denominator used for the rate, or a numeric completion-rate result.

Completion is a practical feasibility measure: it indicates whether participants remain engaged through the study requirements as defined by the investigators. For an intervention study, that can help assess whether the study procedures and intervention are workable in the population of interest. It is distinct from a measure of cognitive improvement or clinical benefit. A completion rate alone would not show whether participants gained skills or experienced a change in cognitive function.

To interpret a rate, readers need a clear definition of completion, the number meeting that definition, and the relevant denominator. The denominator might depend on which participants were enrolled, started the intervention, or were eligible for assessment, but the record does not specify the rule used. No assumptions about that rule are warranted. Reasons for non-completion, if any, are not reported in the registry record.

The record’s outcome description identifies the feasibility question but does not provide the observed endpoint result or a precision estimate. Consequently, it is not possible to assess how consistent or uncertain the completion experience was from the registry entry alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the study design and outcome definitions, but does not report the statistical methods used to analyze the primary or secondary outcomes. The distinctions below explain how such measures are generally interpreted; they should not be taken as a description of methods used in this study.

What does a completion rate represent?

In general, a completion rate is a proportion: the number of participants meeting a stated completion definition divided by a stated denominator. The definition is essential. Completion could refer to finishing intervention activities, completing assessments, or meeting a broader study requirement. Different definitions can produce different interpretations, so the operational rule should be explicit. The registry describes the endpoint as study completion rate but does not report the rule, numerator, denominator, or observed estimate.

A count and a rate answer different questions. A count states how many participants met the definition; a rate puts that count in relation to a relevant group. Reporting both, along with a clear denominator, helps readers understand what the endpoint represents. Neither can be reconstructed from the enrollment figure alone when the completion outcome is not reported.

How should uncertainty be considered?

In general, a confidence interval expresses the range of estimates compatible with the data under a statistical procedure and its assumptions. It helps distinguish a precise estimate from one that is uncertain. For a proportion, uncertainty depends on the observed count and denominator, as well as the method used to form the interval. The registry record does not report an interval for the primary outcome, and no interval can be inferred without the outcome data and analysis method.

A feasibility study’s estimate can be useful for planning and for assessing whether procedures appear workable, but its uncertainty remains important. A point estimate by itself would not describe how much the result could vary in another sample. In this record, the absence of a completion result means there is no point estimate to interpret and no basis for describing its precision.

What do the other outcomes measure?

The listed secondary outcomes address different constructs. The skill-description outcome concerns whether participants described at least one MAAT-G skill. The FACT-Cog outcome concerns pre-post change in self-reported cognitive function using that instrument. Mean usability concerns participants’ usability ratings, though the measure and its scale are not reported in the registry record. These outcomes are not substitutes for the primary completion endpoint: they concern reported skill use, cognitive function, and usability rather than study completion.

Pre-post change is generally a within-participant comparison of measurements at different times. Interpretation depends on the assessment schedule, scoring rules, completeness of paired measurements, and analysis method. Those details and the results are not reported in the registry record. A pre-post change in a single group would describe a temporal pattern, not isolate an intervention effect from other explanations.

What can a single-group design estimate?

A single-group study can describe outcomes observed among participants who take part. It does not directly estimate what would have happened to the same population under a different treatment or no intervention. A randomized or otherwise suitable comparator can support a between-group contrast; this trial has no like-for-like control comparison. Consequently, even if pre-post results were available, causal attribution would be limited.

The design is consistent with a feasibility focus: completion, engagement, and usability can inform whether a larger study is practical. It does not, by itself, establish comparative effectiveness. The registry record does not report a planned confirmatory hypothesis test, a statistical model, covariate adjustment, or an analysis population. No particular procedure should be attributed to the investigators without a registry entry describing it.

What do the planning illustrations mean?

General sample-size planning translates an assumed effect, variability, significance level, and power target into a sample-size requirement under specified design assumptions. The planning framework described for the sample-size illustrations uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. These are planning assumptions, not a description of the actual single-group trial design. The illustrations are not an observed power calculation and do not show that the study had a particular probability of detecting an effect.

Because the trial has no control arm, a two-arm planning framework does not represent the observed design. The record does not report the numerical illustration results in the information available for this analysis, so no sample-size value or implied effect can be stated. More generally, calculations based on an observed effect can be unstable when that estimate is imprecise; planning should make assumptions explicit rather than treat an observed estimate as a guaranteed future effect.

Overall, the statistical approach used for the posted outcomes, including interval construction and handling of incomplete measurements, is not reported in the registry record. The general concepts above clarify what would be needed for interpretation, but they do not fill gaps in the documented analysis.

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("MAAT-G Intervention")
n      <- c(12)
events <- c(10)
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  MAAT-G Intervention  12  10  83.3  51.6  97.9  55.2  95.3  54.6  95.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and identifies three named secondary outcomes: description of at least one MAAT-G skill, pre-post change in FACT-Cog cognitive function, and mean usability. The available record does not identify the remaining outcome measures or provide the results for the named outcomes. It also does not report whether the investigators specified a hierarchy among outcomes or adjusted for multiple comparisons.

Multiplicity arises when several outcomes or statistical tests are examined. In general, interpreting many results without a prespecified strategy can increase the chance of emphasizing an apparently notable finding that arose by chance. Possible approaches include designating a primary outcome in advance, defining a hierarchy, or applying a multiplicity adjustment. Which approach, if any, was used in this study is not reported in the registry record. No claim about statistical significance across outcomes can be made from the information available.

Missing-data handling is also not reported. The record does not state how participants with incomplete intervention participation, missing assessments, or unavailable outcome measurements were treated. It does not report whether analyses used all enrolled participants, only participants who completed the intervention, or another analysis population. These choices can affect a completion estimate and the interpretation of pre-post outcomes.

The 12 participants listed as enrolled and the 10 participants at risk in the adverse-event entry are different recorded counts. Their relationship, and any reasons for the difference, are not reported in the registry record. The endpoint denominator should not be inferred from either figure. Without participant flow and analysis-population definitions, readers cannot assess whether missing observations could have influenced the outcome summaries.

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 0% reporting threshold.

The safety listing records 0 serious adverse events among 10 participants at risk in the MAAT-G Intervention group. It also records 0 other adverse events among 10 participants at risk, and 0 deaths. These are the counts and denominators in the registry entry; the listing does not provide further detail on event ascertainment or follow-up.

The safety denominator of 10 differs from the enrollment figure of 12. The reason is not reported in the registry record, so the entries should not be treated as covering all enrolled participants unless additional documentation establishes that. The record also does not state how adverse events were defined, how often they were assessed, or how missing safety information was handled.

A zero count in a registry entry means that no events are listed for the recorded group and denominator. It does not establish that an intervention has no risk, particularly when the number observed is limited and the ascertainment details are unavailable. The registry record lists no serious-event terms. These safety figures should be read as descriptive reporting, not as proof of safety or a comparative safety estimate.

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

The record establishes that MAAT-G was studied as a behavioral intervention in a completed, single-group feasibility study enrolling 12 older cancer survivors with mild cognitive impairment. It describes workshops and workbook use, with 8 workshops in the arm description, and names completion rate over 10 Weeks as the primary endpoint. It does not report the completion result, so the central feasibility outcome cannot be quantified.

The record also lists secondary outcomes concerning participants’ descriptions of MAAT-G skills, pre-post FACT-Cog change, and mean usability. Their results are not reported in the registry record. Therefore, the available information does not establish what participants reported, whether cognitive-function scores changed, or how usable the intervention was considered. The study title and rationale do not substitute for outcome data.

Because this was a single-group study without a concurrent comparator, the design cannot support a direct estimate of the intervention’s effect relative to another condition. A change measured before and after an intervention, if reported, could be consistent with an intervention effect but could also reflect other influences. The record does not report analyses designed to separate those possibilities.

The safety entries report no serious or other adverse events among 10 participants at risk and 0 deaths, but that denominator does not match the enrollment count, and the reason is not reported. These entries are not evidence that no risk exists. Nor can they be used to make a comparative safety claim.

In short, the registry documents the study’s rationale, intervention, design, enrollment, primary endpoint, selected secondary outcomes, and safety counts. It does not provide the outcome results needed to decide how feasible the intervention was in practice or to draw conclusions about cognitive change, usability, or comparative effects.

14. Why This Trial Matters Statistically

Feasibility questions are important when an intervention is being evaluated in a population and setting where the practicality of delivery is itself uncertain. Completion can help describe whether participants remain engaged through study requirements. Skill descriptions and usability measures can add information about participants’ experience. These are distinct from clinical-effectiveness questions, and separating them helps keep conclusions aligned with what a study was designed to assess.

This study focuses on older cancer survivors with MCI and evaluates MAAT-G, an intervention tailored for older adults. Its single-group design is consistent with describing experience in the enrolled group, while not supplying a randomized comparison. That distinction matters statistically: an intervention can be studied for feasibility without the design supporting a causal comparison of outcomes.

Clear reporting is especially important for a completion endpoint. The definition of completion, the number completing, the denominator, and reasons for non-completion would let readers understand the feasibility estimate and its precision. Those results are not reported in the registry record. Their absence limits what can be learned from the entry even though the primary question is stated.

The registry’s additional outcomes could broaden the description beyond completion, but their results and analysis details are also not reported. The safety entries offer descriptive counts with an at-risk denominator that differs from enrollment, leaving the relationship between those populations unclear. Together, these gaps show why a registry’s design and outcome labels should be distinguished from its reported results.

Statistically, the study is most appropriately read as a feasibility effort with documented design features, not as a controlled test of effectiveness. A clear account of participant flow, endpoint results, uncertainty, and analysis populations would be needed for a fuller assessment of what the observed study experience supports.

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 completion-rate result. It also does not give the endpoint definition, the numerator or denominator, or reasons for non-completion. Enrollment of 12 cannot stand in for the number completing or the number analyzed.

The study is single-group, allocation is listed as NA, and masking is listed as none. Without a comparator, there is no concurrent basis for estimating how outcomes would differ under another condition. Any change over time, if outcome data were available, would not by itself establish that MAAT-G caused the change.

Important methodological details are not reported in the registry record, including recruitment and eligibility procedures, intervention fidelity, the timing and completeness of assessments, statistical methods, and the analysis population. The record does not describe how missing data were handled or whether multiplicity adjustments were used. The named secondary outcomes lack reported results, and two of the five listed outcome measures are not identified in the information available for this analysis.

Safety reporting has a separate denominator: 10 participants at risk, compared with enrollment of 12. The reason for that difference and the event-collection procedures are not reported. The recorded zero counts should therefore be interpreted narrowly as registry entries, not as proof that events did not occur outside the recorded group or that no risk exists.

These limitations concern what can be concluded from the registry record. They do not establish that the study lacked procedures or analyses; rather, those details are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment — NCT05258058.
• Registry record last updated 2024-07-10; status last verified 2024-06.
• Results first posted 2024-07-10.
• 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.

19. Record Summary

NCT05258058 is a completed, single-group behavioral study of MAAT-G in older cancer survivors with MCI. The registry lists enrollment of 12, a start date of 2021-12-10, and a primary completion date of 2023-07-20. The official title identifies the study as Phase I; the phase field is NA.

The intervention description specifies workshops and participant workbook use, with 8 workshops. The primary endpoint is feasibility completion rate over 10 Weeks. The registry also names secondary outcomes involving skill description, pre-post FACT-Cog change, and mean usability.

The primary and secondary outcome results are not reported in the registry record. Safety entries record 0 serious adverse events and 0 other adverse events among 10 participants at risk, with 0 deaths. The reason the safety denominator differs from enrollment is not reported.