This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study (NCT04243512), a na na study. The primary outcome is Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04243512 |
| Phase | NA |
| Condition | Cancer Survivorship |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 39 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Rochester |
| Results posted | Yes |
2. Clinical Question
The study asks whether a time-restricted eating intervention can be delivered to cancer survivors with fatigue, and describes adherence as its primary feasibility measure. It does not ask a randomized treatment-versus-control question: the registry record identifies a single-group study with no allocation to different interventions and no comparator group.
Population
Cancer survivors with fatigue. The registry record lists Cancer Survivorship as the condition and states that the investigators will assess feasibility among cancer survivors with fatigue. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Time-restricted eating. Participants were asked to follow the pattern for 14 consecutive days and encouraged to consume food and beverages within a 10-h time window. Water was encouraged at any time.
Comparator
There is no separate comparator group in this single-group study. The registry record does not describe a usual-care group, placebo, or alternative eating pattern for comparison.
Primary question
What was the mean percent of days participants adhered to the TRE dietary pattern during the 14 days? The record defines the outcome but does not report its observed value.
Accordingly, the statistical focus is on describing adherence within the enrolled group, rather than estimating a between-group contrast. The available record does not establish whether participants found the schedule acceptable, whether the intervention was feasible by other criteria, or how adherence varied across participant subgroups. Those questions require measures and results that are not reported in the registry record.
3. Trial Design
The registry record describes a completed, single-group behavioral feasibility pilot titled “Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study.” The study was sponsored by the University of Rochester and enrolled 39 participants. Its status is COMPLETED. The recorded start date is 2020-06-30, and the primary completion date is 2021-09-01.
The intervention was time-restricted eating. Participants were asked to follow the eating pattern for 14 consecutive days and were encouraged to consume food and beverages only within a 10-h window. Water was encouraged at any time. The description establishes the intended schedule, but details such as how adherence was monitored, how participants were supported, and whether the schedule was modified are not reported in the registry record.
The design is single group, with no allocation to a comparator intervention. Masking is listed as NONE, and phase is listed as NA. These entries do not describe an attempt to conceal the intervention from participants; however, the record does not provide further details about who collected or assessed the outcome.
The registry lists one primary outcome measure: mean percent of days that participants adhere to the TRE dietary pattern, assessed over 14 days. It also records no analysis entries. The observed adherence value, its full range, and any uncertainty estimate are not reported in the registry record. Therefore, the design and intended endpoint can be described, but the available information does not support a quantitative conclusion about the adherence achieved.
A single-group feasibility design can describe what happened among participants who enrolled and undertook the intervention. Without a comparator group, it cannot separate changes associated with the intervention from other influences over the same period. The record does not report a protocol or detailed statistical analysis plan, so the planned handling of such considerations cannot be established.
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
| Stage | Time-restricted Eating |
|---|---|
| STARTED | 39 |
| COMPLETED | 36 |
| NOT COMPLETED | 3 |
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.
| Characteristic | Unit | Time-restricted Eating |
|---|---|---|
| Participants analysed | 39 | |
| Age, Continuous | years | 61.5 (SD 12.5) |
| Sex: Female, Male: Female | Participants | 36 |
| Sex: Female, Male: Male | Participants | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 38 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 |
| Race (NIH/OMB): White | Participants | 34 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 39 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern, measured over 14 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | percent of days |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the mean percent of days that participants adhered to the TRE dietary pattern during the 14-day timeframe. Adherence is defined in the registry as the percent of days each participant followed the 10-h pattern. This measure describes the frequency of adherence across the intervention period and is directly aligned with the study’s stated feasibility aim.
Using a percent-of-days measure expresses adherence relative to the observation period rather than as a simple count of compliant days. The mean then summarizes participant-level adherence across the group. The registry specifies full range as the dispersion measure, which would describe the spread from the lowest to the highest participant value. The actual mean and range are not reported in the registry record, so the degree of adherence and variation between participants cannot be assessed from the posted information.
As a feasibility endpoint, adherence can indicate whether participants followed the requested schedule during the intervention. It does not, by itself, establish acceptability, ease of implementation, or effects on fatigue or other health outcomes. The registry record does not report those outcomes or additional feasibility criteria. It also does not report the method used to collect adherence information, how missing days were handled, or how the participant-level percentages were combined. Those details matter when interpreting what the endpoint represents in practice.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a relevant feasibility question and a measure intended to address it: adherence to a time-restricted eating schedule among cancer survivors with fatigue. It gives the planned intervention window and defines the primary outcome, but it does not report the observed adherence mean or full range. Without those values, the endpoint cannot show how often participants followed the eating pattern or how much adherence varied across participants.
The registry lists 39 participants as enrolled. That enrollment figure gives context for the size of the pilot, but it does not substitute for an outcome result. The record contains no analysis entries, and the posted information does not provide a confidence interval, standard error, or other estimate of precision for adherence. The available record therefore does not permit an assessment of either the observed level of adherence or the uncertainty around it.
The study has no separate comparator group. Its findings, if reported, would describe the enrolled group during the intervention rather than establish a causal effect relative to another eating pattern or usual care. In general, an uncontrolled before-and-after or single-group observation cannot rule out other explanations for observed changes. For the primary endpoint in this record, the main issue is more immediate: the endpoint’s numerical result is not reported, so even a descriptive estimate is unavailable.
The stated aim is feasibility of delivering the intervention, not a comparative efficacy question. Adherence is one aspect of feasibility, but a single adherence measure does not capture all practical questions about implementation. The registry record does not report additional measures such as recruitment, retention, participant acceptability, or reasons for nonadherence. It would be inappropriate to infer those outcomes from the enrollment or safety counts.
The registry does report adverse-event counts. These counts should be read as safety reporting, not as evidence of the primary adherence outcome. The record lists no serious adverse events and no deaths in the intervention group, while two participants are listed as affected by other adverse events. The record does not provide event descriptions in the top serious terms field, and it does not establish whether the other adverse events were caused by the intervention.
Overall, the record supports a description of the study design, intervention, planned adherence measure, enrollment, and listed adverse-event counts. It does not provide the primary endpoint result or a detailed statistical analysis. As a result, the central feasibility outcome cannot be quantified from the posted results. No conclusion about intervention effectiveness or the likely experience of people outside this enrolled group follows from the information reported.
9. Statistical Methods Explained
The registry defines the primary outcome as a mean and identifies full range as its dispersion measure. These terms describe a planned summary, not a reported result. The numerical mean and range are not reported in the registry record. The record also lists no analysis entries, so the exact calculations used, if any, cannot be established from the available information.
What a mean describes
In general, a mean is an average across the participant-level values being summarized. Here, each participant’s value is defined as the percent of days adhering to the 10-h dietary pattern during the 14-day intervention. Averaging those percentages would provide a group-level description. It would not imply that every participant had that level of adherence: individual values may differ, which is why a measure of spread is also useful.
The registry specifies full range as the spread measure. In general, a range identifies the lowest and highest observed values and gives a simple indication of how far apart the extremes are. It does not show how values are distributed between those extremes, and it can be affected by unusual low or high observations. Because the actual range is not reported in the registry record, the observed variability cannot be described.
What uncertainty measures would add
In general, a confidence interval expresses uncertainty around an estimate under a specified statistical method and its assumptions. It is not a guarantee that a particular value is correct, nor does it show how individual participants responded. A confidence interval for a mean would help readers assess the precision of the group estimate, while participant-level summaries would be needed to understand the distribution of adherence. No confidence interval or other precision estimate for the primary endpoint is reported in the registry record.
The record does not state a statistical model, a hypothesis test, or a threshold for interpreting adherence as feasible. It also does not report a sample-size justification. Those details should not be inferred from the study’s enrollment or from the fact that the trial is described as a feasibility pilot.
Planning illustrations and observed power
General sample-size planning illustrations can show how the number of participants might depend on a chosen effect size, significance level, allocation, and statistical approximation. The stated assumptions for such illustrations refer to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. Time-to-event illustrations use total events; other illustrations express participants per arm. These are hypothetical planning assumptions, not a description of the single-group design used in this study. Any resulting sample-size figures are planning illustrations and are not observed power.
Observed power is not a substitute for reporting an estimate and its uncertainty. In general, once a study has been completed, the observed data and their precision are more informative than a retrospective power calculation. The registry record does not report the primary outcome result needed to evaluate the adherence estimate or its precision. It also does not establish that the illustration assumptions were part of the study’s original design.
Why the design matters
Because this is a single-group study, there is no randomized contrast to estimate. A between-group treatment effect, such as a difference in mean adherence or in a clinical outcome, cannot be calculated from the listed design. The registry record does not identify an external or historical comparator. General explanations of comparative tests therefore do not describe an analysis reported for this trial.
For an adherence percentage, interpretation also depends on the underlying observation process. In general, it matters whether all days are observed for every participant, what qualifies as adherence on a given day, and how unavailable reports are treated. The registry describes adherence as the percent of days following the pattern but does not report the collection instrument, operational rules beyond the 10-h schedule, or a missing-data procedure. These omissions limit reproducibility and make it difficult to assess whether participant percentages were constructed consistently.
Finally, a group mean alone may conceal heterogeneous experiences. General statistical practice is to consider both a central summary and the spread of individual observations, alongside clear information about the number of participants contributing data. The registry names full range as the planned spread measure, but the observed values and endpoint analysis population are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity concerns arise when many outcomes, comparisons, or analyses are tested: the more questions examined, the greater the chance that a nominally unusual result occurs by chance. The registry lists one primary outcome measure, the mean percent of days participants adhered to the TRE dietary pattern. It does not report any analysis entries, additional outcomes, or a multiplicity adjustment. Whether other analyses were conducted, and whether any adjustment was planned, is not reported in the registry record.
The record does not describe missing-data handling for the adherence endpoint. It does not state how missed days, incomplete diaries, withdrawal, or missing participant-level measurements were treated, or whether any imputation was used. These details matter because an average based only on participants with complete observations can differ from one that includes all enrolled participants under a defined missing-data method. No particular approach should be assumed.
The analysis population is also not described. Although 39 participants are listed as enrolled, the number contributing data to the primary endpoint is not reported in the registry record. The record does not clarify whether the endpoint was intended to use all enrolled participants, only participants who began the intervention, or another defined group. Enrollment should therefore not be read as the number analyzed.
For a feasibility study, transparent reporting of participation, completion, missing observations, and the definition of evaluable data helps readers judge whether the endpoint reflects the intended group. Those details, along with a detailed analysis plan, are not reported in the registry record. The absence of these details does not establish that the analyses were performed incorrectly; it means that their handling cannot be evaluated from the posted information.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Time-restricted Eating | 0 | 39 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Time-restricted Eating | 0 of 39 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Time-restricted Eating | 2 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Time-restricted Eating |
|---|---|---|
| headache | General disorders | 1 of 39 |
| insomnia | General disorders | 1 of 39 |
The registry lists a Time-restricted Eating group with 39 participants at risk for serious adverse events; zero are recorded as affected. It also lists 39 participants at risk for other adverse events, with two recorded as affected. Deaths are listed as zero. These are counts in the registry record, not rates calculated from the counts.
The serious-adverse-event field and the other-adverse-event field are separate categories. The two affected participants are listed under other adverse events; the record does not provide their event descriptions. The top serious terms field is empty. The listed counts do not identify whether an event was considered related to the intervention, how severe the other events were, when they occurred, or whether any participant had more than one event. Those details are not reported in the registry record.
Zero recorded serious adverse events and zero deaths are bounded observations from this enrolled group and reporting period. They do not establish that no risk exists, and they do not quantify risks in other populations or settings. The registry record also does not explain its adverse-event collection procedures or reporting thresholds. The counts should therefore be read as the safety information entered in the record, without inferring causation or broader safety conclusions.
12. What the Result Does, and Does Not, Mean
The result that can be described is limited to what the registry records: a completed single-group feasibility pilot enrolled 39 participants, planned a 14-day time-restricted eating intervention, and defined adherence as its primary outcome. The record does not report the observed mean percent of adherent days or the full range. It therefore does not show how well participants adhered to the schedule or how consistent adherence was across the group.
The absence of a reported endpoint value is not evidence that adherence was low, high, or absent. It means the numerical result is not reported in the registry record. Similarly, the lack of analysis entries does not establish that no analysis was performed; it means an analysis is not documented in the posted record.
Even with a reported adherence value, the study’s single-group design would support a descriptive account of participants in the study, not a randomized comparison against another strategy. It could not, on its own, isolate the intervention’s effect relative to a comparator. The record also does not report a clinical outcome analysis that would establish changes in fatigue or other health outcomes.
Adherence is relevant to whether a dietary schedule was followed, but it is not synonymous with acceptability, practicality, or benefit. The registry does not report enough information to characterize those broader dimensions. Nor does the enrollment count establish how representative the participants were of cancer survivors with fatigue generally; eligibility details and participant characteristics are not reported in the registry record.
The adverse-event counts add limited descriptive safety information: no serious adverse events or deaths are listed, and two participants are listed as affected by other adverse events. These counts do not show causation or rule out uncommon harms. Taken together, the record documents the study plan and selected counts but leaves its principal adherence outcome unavailable. No conclusion about effectiveness, comparative benefit, or safety beyond the recorded observations is warranted from these entries.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of a feasibility question that is distinct from a comparative treatment question. Its stated aim is to assess delivery of a time-restricted eating intervention among cancer survivors with fatigue, and its primary endpoint focuses on adherence during the intervention. That endpoint is conceptually aligned with a practical question: whether participants followed the requested schedule.
The design also illustrates why the question and analysis must be interpreted together. A single-group study can describe adherence within the enrolled group, but it does not provide a randomized comparator. A reader should not interpret its results as a between-group effect, even if a numerical endpoint result is reported elsewhere. For this record, the endpoint result itself is not reported, so even the planned descriptive question cannot be answered quantitatively.
Reporting the mean together with a spread measure is useful in principle because a group average can hide differences among individuals. The registry specifies full range, which could indicate the extremes, but the record does not include the actual values or explain the underlying observation process. Clear reporting of individual variability, missing observations, and the number analyzed would strengthen interpretation of a feasibility endpoint.
The record also demonstrates the importance of separating enrollment from analysis. Enrollment is documented as 39, but the number contributing data to the adherence endpoint is not reported in the registry record. Without that information, readers cannot tell how much of the enrolled group is represented by the intended outcome summary.
Finally, statistical transparency matters even for a pilot whose primary purpose is feasibility. A defined outcome, clear missing-data handling, and an account of the analysis population help readers understand what a summary means and how it could inform later research. The posted record supplies the endpoint definition and broad design, but not the observed endpoint result or enough analysis detail to evaluate it.
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 for interpretation is that the primary adherence result is not reported in the registry record. Although the endpoint is defined as a mean percent of days and full range is named as the dispersion measure, neither observed value is available. The main feasibility question therefore cannot be answered from the posted results.
The record lists 39 enrolled participants, but the number who began or completed the intervention and the number contributing to the primary endpoint are not reported in the registry record. Eligibility criteria, participant characteristics, recruitment details, and reasons for withdrawal or nonadherence are also not reported. These omissions limit assessment of whom the findings would describe and whether the enrolled group is representative of the intended population.
The single-group design does not include a comparator. Any reported experience during the intervention would be descriptive and could not establish a comparative effect. The registry does not report a detailed statistical plan, the method used to measure adherence, operational rules for classifying adherence, or the treatment of missing observations. This limits reproducibility and assessment of possible measurement or analysis biases.
The study’s stated feasibility aim may involve considerations beyond adherence, but additional feasibility measures are not reported in the registry record. The record also does not report an analysis of fatigue or other clinical outcomes. Safety reporting is limited to the listed counts, without descriptions of the other adverse events, attribution, or collection procedures.
These limitations concern what can be evaluated from the registry record. They do not show that unreported procedures or analyses were absent from the study itself, but those details cannot be assessed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study — NCT04243512.
- Registry record last updated 2023-05-11; status last verified 2022-06.
- Results first posted 2023-05-11.
- 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.
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18. Record Summary
NCT04243512 is a completed, single-group behavioral feasibility pilot titled “Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study,” sponsored by the University of Rochester. The registry lists 39 participants enrolled, a start date of 2020-06-30, and a primary completion date of 2021-09-01. Phase is listed as NA, masking as NONE, and allocation as NA.
Participants were asked to follow time-restricted eating for 14 consecutive days, with food and beverages encouraged within a 10-h window and water permitted at any time. The primary endpoint was mean percent of days adhering to the dietary pattern, with full range specified as the dispersion measure. The endpoint result and detailed analysis are not reported in the registry record.
The intervention group is listed as having zero serious adverse events, two participants affected by other adverse events, and zero deaths. The record does not provide descriptions of those other events.