Memory and Attention Adaptation Training-Geriatrics (MAAT-G): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Memory and Attention Adaptation Training-Geriatrics (MAAT-G) (NCT04230941), a na na study. The primary outcome is Experience Interview.

2. Clinical Question

The study was designed to adapt Memory and Attention Adaptation Training for older adults and test the usability of the adapted intervention. The registry rationale notes that cancer-related cognitive dysfunction can affect patients receiving chemotherapy and that older adults may be at greater risk. It also describes MAAT as promising for perceived cognition in younger cancer survivors, while identifying a need to adapt it for older adults.

This is an intervention-development and usability question, not a test of whether MAAT-G improves cognition relative to a control condition. The primary outcome is qualitative: patient and caregiver interview transcripts are to be analyzed for themes. The registry record does not report the resulting themes or a numerical primary-outcome result. Accordingly, the clinical question concerns experience with the intervention, while comparative benefit and efficacy are not established by this study design or record.

3. Trial Design

NCT04230941 is a completed Phase I study of Memory and Attention Adaptation Training-Geriatrics (MAAT-G), sponsored by the University of Rochester. The registry lists the phase as NA, allocation as NA, masking as NONE, and the model as SINGLE GROUP. Enrollment was 4. The study dates recorded are 2020-06-12 for start and 2021-04-01 for primary completion.

MAAT-G is identified as a behavioral intervention. Its description specifies workshops and participant workbook use, with 8 workshops. The registry summary says the study aimed to adapt MAAT for older adults using feedback from older adults with cancer and their caregivers, and to test usability. The single-group design fits an early-stage adaptation and usability aim: it can collect experiences with the intervention, but it does not create a randomized treatment contrast.

The primary outcome is called Experience Interview. It is described as a semi-structured interview with patients and caregivers about their experience with MAAT-G. The stated timeframe is post-intervention, up to 2 weeks. Transcript analysis is intended to identify themes concerning intervention benefit and barriers and facilitators. MAX QDA software is named for qualitative analysis coding.

The registry lists 2 outcome measures and 0 analyses. A comparative statistical analysis plan, a control condition, and an allocation procedure are not reported in the registry record. The record’s completed status describes trial status; it does not by itself mean that outcome findings are available. Numerical primary-outcome findings and interview themes 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.

Overall 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 Experience Interview, measured over Post-Intervention (up to 2 weeks).

The primary outcome, Experience Interview, concerns how patients and caregivers describe their experience with MAAT-G. The interview is semi-structured and takes place post-intervention, up to 2 weeks. Its stated analytic focus is themes about intervention benefit and about barriers and facilitators. The registry specifies transcript coding and qualitative analysis using MAX QDA software.

This kind of endpoint is appropriate to an adaptation and usability study because interview accounts can identify what participants found helpful or difficult and what may support or impede use. It captures reported experience rather than a standardized cognitive test score or a comparison of change between intervention and control groups. Although the endpoint unit is participants and the parameter is described as a count of participants, the registry does not report a numerical count for this outcome or the qualitative themes.

Interpretation therefore depends on the interview content and the approach used to code and organize it. Without reported findings, readers cannot determine which themes arose, how frequently they occurred, or how participants’ accounts were interpreted. The registry record also does not report the interview guide, coding procedures in detail, or how differences in coding were handled. The endpoint can address experience and usability, but it does not by itself establish a causal effect on cognition.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods described in the registry should be read in light of the study’s early-stage adaptation and usability purpose. The intervention was delivered in a single group, and the primary outcome was a qualitative interview. These features differ from a randomized efficacy trial, where an outcome is compared between assigned groups under a prespecified statistical model.

What does a single-group design allow?

A single-group design can describe what happened among people who took part in the intervention and can support collection of feedback about its delivery. It has no concurrent control group to represent what would have happened without MAAT-G or under a different program. As a general statistical principle, a treatment effect is a contrast between outcomes under alternative conditions. Without a comparison condition, a post-intervention observation alone cannot identify that contrast.

The registry lists allocation as NA and the model as SINGLE GROUP. The record also explicitly identifies the study as not being a randomized comparison. Thus, statistical methods for estimating a randomized between-group effect do not apply to the primary question as recorded.

How should the interview outcome be understood?

The Experience Interview is semi-structured, and its stated purpose is to elicit patient and caregiver experiences. Qualitative analysis organizes text into themes, such as perceived benefit and barriers or facilitators. The goal is to interpret the content of accounts, rather than to reduce each account to a treatment-effect estimate. Counts of participants can describe how many people contributed to an outcome when those counts are reported, but a count alone does not convey the meaning or context of interview themes.

The registry names MAX QDA software for qualitative coding. Software can support organizing and coding transcripts; naming a program does not, by itself, specify the analytic framework or demonstrate the reliability of coding. Details such as how a codebook was developed, whether multiple analysts coded transcripts, and how disagreements were resolved are not reported in the registry record.

What do the analysis and planning details mean?

The record lists 0 analyses. It does not report a statistical model, hypothesis test, confidence interval, or numerical estimate for the primary outcome. A confidence interval is a general statistical expression of uncertainty around an estimate: narrower intervals indicate greater precision under the assumptions of the method. No such interval is reported for this interview outcome.

The stated sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect is described as a stated fraction of the observed effect. For time-to-event settings, the assumptions specify total events; for other settings, they specify participants per arm. Those assumptions do not make this single-group study a two-arm randomized comparison. A planning illustration is not observed power, and it is not a result from the trial. The registry record does not report numerical planning estimates or a trial-specific sample-size justification.

Over-dispersion is a general concern when variation in observed counts exceeds what a simple probability model assumes; ignoring it can make uncertainty estimates too optimistic. The record does not report an over-dispersion model, and the qualitative primary outcome does not have a reported count distribution for such an assessment. No model-based quantitative effect should be inferred from the fact that a count parameter is listed.

What can the adverse-event counts establish?

Adverse-event entries are counts among the listed groups, not comparative rates from randomized arms. With no control group and limited enrollment, these counts provide descriptive safety information only. They cannot establish whether an event pattern differs from an alternative treatment or from the expected background experience. The record does not report a statistical safety analysis.

Overall, methods interpretation should remain aligned with the information actually recorded: a single-group intervention, an interview-based primary outcome, no analyses listed, and no numerical interview findings. General statistical ideas such as confidence intervals and power do not fill in missing outcome results or create a comparative estimate.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and 0 analyses. It does not describe how multiple outcomes were handled statistically, whether any hypotheses were designated as confirmatory, or whether an adjustment for multiple testing was planned. Multiplicity is a general concern when many outcomes or tests are examined: the chance of a nominally notable result can increase as more tests are considered. In this record, no reported inferential tests are available to evaluate, and no multiplicity procedure is reported in the registry record.

The primary outcome is qualitative, with interviews intended to identify themes about experience, benefit, barriers, and facilitators. The registry record does not report the resulting themes, transcript completeness, or how missing interview information was handled. It also does not report reasons for any missing data or a strategy for addressing them.

Analysis populations are not described in the registry record. In a randomized study, analysis-population definitions can clarify which participants are included in each estimate and how departures from assigned treatment are handled. This trial is single-group, but the same transparency matters: readers would need to know who completed the intervention, who contributed interview data, and how incomplete data affected the qualitative analysis. Those details are not reported in the registry record.

Interim analyses and a statistical analysis plan are not reported in the registry record. Their absence from the record should not be interpreted as evidence that a particular procedure was or was not used. Without the analysis methods and outcome findings, the appropriate reading is that multiplicity, missing-data handling, and analysis-population choices cannot be assessed from the registry information.

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 MAAT-G Intervention group, the registry records 4 participants at risk for serious adverse events and 0 affected. It also records 4 at risk for other adverse events and 0 affected, with 0 deaths. For the Caregiver group, it records 1 at risk for serious adverse events and 0 affected, 1 at risk for other adverse events and 0 affected, and 0 deaths. No top serious-event terms are listed.

These are descriptive counts for the registry’s safety categories. They are not rates adjusted for time at risk, and no comparative safety estimate is reported. The MAAT-G and Caregiver entries are separate listed groups, not randomized treatment and control arms. The counts should not be combined or used to infer an unreported denominator.

Zero recorded events in a small study does not establish that the intervention has no risks. The record does not report the safety-monitoring procedures, exposure duration for these counts, or a statistical analysis of adverse events. The figures describe what was entered in the registry, while their precision and generalizability are limited by the study’s scale and lack of a comparison group.

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

The registry record documents a completed, single-group Phase I study intended to adapt MAAT for older adults with cancer and test usability. It specifies 8 workshops with participant workbook use and a post-intervention interview, up to 2 weeks, with patients and caregivers. The primary interview is intended to explore experience, perceived benefit, and barriers and facilitators.

What the record does not provide is the primary outcome result. It does not report the interview themes, a numerical outcome count, or a comparative estimate. The record therefore cannot show whether participants described benefits, what barriers arose, or how usable the intervention was in practice. Completion status alone does not supply those findings.

The design also does not answer whether MAAT-G improves cognitive function relative to another condition. A single-group study lacks a concurrent control comparison, and the listed primary outcome is qualitative rather than a reported cognitive outcome measure. The background rationale discusses cancer-related cognitive dysfunction and concerns among older adults, but those statements are not trial results.

The adverse-event entries report no affected participants in the listed categories and no deaths. These descriptive counts do not prove absence of risk and do not compare MAAT-G with another intervention. The registry lists no analyses, and it does not report a statistical plan or inferential results.

In short, the record establishes the study’s design, intervention, intended experience assessment, status, and safety counts. It does not establish efficacy, comparative safety, or the actual qualitative findings. Those conclusions would require outcome results and additional methodological detail that are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically important because it illustrates a distinction between developing an intervention and testing its comparative effect. MAAT-G was adapted for older adults, with the stated aim of testing usability and gathering stakeholder feedback. An interview-based endpoint can be relevant at this stage because participants’ descriptions may identify practical barriers and facilitators that a numerical efficacy outcome would not capture.

At the same time, the design determines the scope of valid conclusions. A single-group study can describe experiences in the group studied, but cannot isolate an intervention effect against a control condition. The study’s primary question is therefore not the same as the question asked by a randomized efficacy trial. Keeping that distinction clear prevents a rationale for the intervention from being mistaken for evidence of benefit.

The record also shows why outcome reporting matters. It describes the intended qualitative analysis but does not report its themes or a numerical result. Without those findings, readers cannot assess what participants experienced, even though the trial is marked completed. A clear account of who contributed interviews, how transcripts were coded, and how missing information was handled would further support interpretation.

Finally, the safety entries are counts rather than comparative evidence. They can be reported transparently, but their meaning is constrained by the study’s scale and single-group design. The central statistical lesson is to match claims to the design and results actually available: this record describes an adaptation and usability study, not a randomized estimate of treatment benefit.

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 main limitation for interpreting this record is that the primary outcome findings are not reported. Although the Experience Interview and its intended qualitative themes are described, the actual themes and numerical outcome result are absent. This prevents assessment of participants’ reported experience and the usability findings.

The study is single-group and has no randomized control comparison. Any post-intervention observations cannot distinguish intervention-related changes from other influences. The enrollment was 4, limiting the range of experience that could be represented and the precision of any numerical summaries. The registry record does not report demographic or clinical characteristics that would help readers judge the population represented.

Important qualitative-method details are also not reported in the registry record, including the interview guide, recruitment and completion details, coding framework, analyst procedures, and how coding differences were addressed. The record names MAX QDA software but does not specify these analytic steps. Missing interview data and their handling are not described.

The registry lists 0 analyses and does not report a statistical analysis plan, analysis populations, or interim analyses. It is therefore not possible to assess prespecified quantitative hypotheses or analytic choices. The study’s Phase I designation and completed status do not resolve those omissions. The adverse-event entries are descriptive and lack a randomized comparator; safety monitoring and exposure details are not reported in the registry record. These limitations constrain conclusions to the study description and recorded counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) — NCT04230941.
• Registry record last updated 2023-11-13; status last verified 2023-11.
• Results first posted 2023-07-19.
• 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

NCT04230941 is a completed, single-group Phase I study of MAAT-G sponsored by the University of Rochester. The registry records enrollment of 4, allocation NA, and masking NONE. The intervention consists of workshops and participant workbook use, with 8 workshops.

The primary outcome is the Experience Interview: semi-structured interviews with patients and caregivers, conducted post-intervention up to 2 weeks, with qualitative analysis focused on perceived benefit and barriers and facilitators. MAX QDA is named for coding. The registry lists 2 outcome measures and 0 analyses; interview findings are not reported in the registry record.

For the MAAT-G Intervention and Caregiver groups, the registry records 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths in each listed group. These are descriptive counts, not comparative safety estimates.