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 Acupressure for Fatigue in Ovarian Cancer Survivors (NCT03763838), a randomized na study. The primary outcome is Change in Level of Fatigue at Week 6.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03763838 |
| Phase | NA |
| Condition | Fatigue, Ovarian Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 171 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The primary outcome population is described as evaluable patients at week 6. The trial concerns people with ovarian cancer and fatigue; further eligibility details and the number evaluable for the primary outcome are not reported in the registry record.
Intervention
Participants in the active acupressure arm used an AcuWand to apply pressure to points described as known to affect physiology, alongside standard of care.
Comparator
The two comparison arms were sham acupressure plus standard of care, using points described as not known to affect physiology, and standard of care alone.
Primary question
The primary question concerns change in self-reported fatigue from baseline to week 6, measured with the Brief Fatigue Inventory. The registry record does not report the arm-specific changes or the comparison results.
This three-arm design can address different contrasts: active acupressure versus sham acupressure, active acupressure versus standard of care, and sham acupressure versus standard of care. Those comparisons answer related but distinct questions. The active-versus-sham contrast compares pressure applied to the designated points with pressure applied elsewhere, with both groups also receiving standard of care. The active-versus-standard-care contrast compares the full active-acupressure regimen with standard care alone. The sham-versus-standard-care contrast can describe the sham regimen relative to standard care.
The primary endpoint is defined as change in fatigue level at week 6, with a baseline-to-week-six timeframe. Although this defines the outcome and time point, the record does not report the observed group means, changes, confidence intervals, or statistical tests. Consequently, it is not possible to determine from the registry record how the groups compared on the primary question, or how precisely any difference was estimated.
3. Trial Design
The registry describes a randomized, parallel-group trial with an enrollment of 171. Its status is completed. The listed start date is 2019-10-07, and the primary completion date is 2024-06-18. The phase is listed as NA. The sponsor is the University of Michigan Rogel Cancer Center.
Participants were assigned to three arms: acupressure plus standard of care, sham acupressure plus standard of care, or standard of care alone. The active arm used an AcuWand to apply pressure to points described as known to affect physiology. The sham arm used the device on points described as not known to affect physiology. The third arm received standard of care only. These descriptions establish the intended distinction between the arms, but details such as the frequency and duration of self-administered sessions are not reported in the registry record.
Masking is listed as quadruple. The registry record does not identify which roles were masked, explain how masking was implemented, or report whether masking was assessed. Random allocation can help balance participant characteristics across groups on average, while masking may reduce some risks of expectation-related influence. Neither label alone establishes that these protections worked as intended in practice.
The primary outcome is change in fatigue level at week 6, from baseline, among evaluable patients at week 6. The outcome is self-reported using the Brief Fatigue Inventory. The record also lists changes in quality of life and sleep quality at week 6 and up to week 24 as secondary outcomes. It does not report the analysis population counts, the group results, or a detailed statistical analysis plan. In particular, the allocation ratio, randomization procedure, and handling of missing week-six assessments 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.
Before assignment: Acupressure plus standard of care- 58 participants allocated, 5 participants did not start treatment. Sham plus standard of care- 58 participants allocated, 2 participants did not start treatment. Standard of care- 55 participants allocated, 4 participants did not start treatment.
Overall Study
| Stage | Acupressure Plus Standard of Care | Sham Acupressure Plus Standard of Care | Standard of Care |
|---|---|---|---|
| STARTED | 58 | 58 | 55 |
| COMPLETED | 37 | 40 | 46 |
| NOT COMPLETED | 21 | 18 | 9 |
Reasons for not completing this period:
| Reason | Acupressure Plus Standard of Care | Sham Acupressure Plus Standard of Care | Standard of Care |
|---|---|---|---|
| Lost to Follow-up | 12 | 9 | 5 |
| Withdrawal by Subject | 4 | 3 | 0 |
| Adverse Event | 0 | 2 | 0 |
| Disease Reoccurrence | 0 | 2 | 0 |
| participants did not start treatment. | 5 | 2 | 4 |
Analysis population for the primary outcome, as defined in the registry: evaluable patients at week 6
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.
Population: Including all subjects who were randomized
| Characteristic | Unit | Acupressure Plus Standard of Care | Sham Acupressure Plus Standard of Care | Standard of Care | Total |
|---|---|---|---|---|---|
| Participants analysed | 58 | 58 | 55 | 171 | |
| Age, Customized | years | 57 (SD 10) | 55 (SD 12) | 57 (SD 12) | 57 (SD 13) |
| Sex: Female, Male: Female | Participants | 58 | 58 | 55 | 171 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 0 | 2 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 1 | 4 |
| Race (NIH/OMB): White | Participants | 51 | 51 | 45 | 147 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 5 | 5 | 13 |
| Region of Enrollment: United States | participants | 58 | 58 | 55 | 171 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Level of Fatigue at Week 6, measured over Baseline to week 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mean score |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in level of fatigue from baseline to week 6, measured using the Brief Fatigue Inventory (BFI). The BFI uses a scale from 0 to 10 for each item: 0 represents no fatigue, while 10 represents fatigue as bad as a person can imagine. The global BFI score is calculated as the average of all items. The registry describes scores of 1-3 as mild, 4-6 as moderate, and 7-10 as severe; it also identifies a global score of 7 or greater as clinically significant.
A continuous score can preserve gradations in reported fatigue rather than reducing each participant to a category. A change score describes how the measure differs between the stated baseline and follow-up time points. To interpret a comparison, however, the score definition alone is not enough: readers also need the observed results for each group, the between-group estimate or other specified comparison, and an indication of its precision. Those results are not reported in the registry record.
The week-six endpoint provides a defined, relatively early follow-up point for assessing the trial’s main fatigue question. The record identifies the primary population as evaluable patients at week 6, but does not explain the criteria for being evaluable or how participants without an assessment were treated in the analysis. The meaning of the endpoint is therefore clear at the level of the instrument and timing, while the estimation and interpretation of the treatment-group contrast remain unavailable.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary fatigue outcome but does not report its numerical results. There are no posted arm-specific week-six changes, between-group estimates, confidence intervals, or p-values in the information recorded for this trial. The main statistical question—how fatigue change differed across the three assigned groups—therefore cannot be answered from the registry record.
This absence matters for interpretation. Knowing that a measure was planned and how it was defined does not reveal the direction or size of the observed changes. Nor does the completed status establish that the primary comparison favored any particular arm. Without estimates and uncertainty measures, it is not possible to judge whether the data were compatible with a range of effects, whether a comparison was statistically distinguishable from no difference, or whether an estimate was sufficiently precise for a substantive conclusion.
The three arms allow more than one meaningful contrast. Active acupressure versus sham acupressure addresses the difference between the two device-based approaches as described in the arm definitions. Active acupressure versus standard care addresses a broader contrast between the active regimen and standard care alone. Sham acupressure versus standard care describes the sham regimen relative to standard care. The registry record does not state which comparisons were designated as primary statistical contrasts, or provide results for any of them.
General statistical interpretation: an estimate describes the observed effect in the analyzed sample, while a confidence interval describes uncertainty around that estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, but neither the estimate nor its interval establishes the practical importance of an effect by itself. A p-value addresses compatibility with a statistical null model; it does not measure the size or importance of an effect. None of these quantities for the primary fatigue outcome is reported in the registry record.
The record states an enrollment of 171, but enrollment alone does not tell readers how many participants contributed to the primary endpoint or whether the groups remained comparable in the analyzed population. The primary population is described as evaluable patients at week 6; its size and the reasons participants might not have been evaluable are not reported. These gaps prevent assessment of precision, attrition, and the possible influence of missing outcome data.
The listed quality-of-life and sleep outcomes extend the scope of planned measurement, but their results are also not reported in the registry record. They cannot be used to fill the gap in the primary endpoint results. The appropriate reading is limited: the record documents the trial question, design, outcome definition, and some safety counts, but does not document the primary efficacy estimates needed to compare fatigue outcomes between arms.
9. Statistical Methods Explained
What does random allocation contribute?
General statistical explanation: random allocation assigns participants to groups through a chance-based process. When implemented as intended, it can reduce systematic differences in participant characteristics between groups, including characteristics that are not measured. It does not guarantee identical groups in a particular trial, and it does not eliminate the need to examine who was enrolled, who contributed outcome data, and how the analysis was conducted.
This trial is recorded as randomized and parallel-group. A parallel design means that participants are assigned to a group and the group comparisons are made across participants rather than by having each participant receive each intervention in sequence. The registry record does not describe the randomization sequence or allocation concealment. It also does not give detailed analysis instructions, so the precise statistical method used for the primary outcome is not reported in the registry record.
What does quadruple masking tell readers?
The masking field is recorded as quadruple. In general, masking is intended to limit the influence of knowledge about group assignment on behavior, outcome reporting, care, or assessment. The label does not specify which people were masked in this trial. It also does not establish whether masking was maintained. Because the BFI is self-reported, a reader would need details about implementation and the participant experience to understand how masking might have influenced reporting; such details are not reported in the registry record.
How should the continuous outcome be understood?
General statistical explanation: a continuous measure retains information about gradations in an outcome. An average summarizes the center of a group’s measurements, but it does not show how individual measurements are distributed. A comparison of average change can be useful when the scientific question concerns the average difference between groups. Its interpretation depends on the exact comparison, the analysis population, assumptions about the data, and the uncertainty around the estimate.
The registry defines the primary endpoint as mean change in BFI level from baseline to week 6. It specifies a 95% confidence interval as the dispersion measure, but does not provide the observed mean changes or intervals. A confidence interval generally gives a range of estimates compatible with the data and the statistical method at a stated confidence level. It is not a range containing a fixed proportion of individual participants’ scores, and it does not remove uncertainty about bias, missing data, or model assumptions.
The BFI also has categories for describing levels of fatigue, while the primary outcome is described as a mean score. These are different ways to represent information: a continuous score retains distinctions within the scale, whereas categories group scores into bands. The registry’s description of the categories and the clinically significant threshold does not report how many participants fell into each category or whether the analysis used categories. The registry record does not report such results.
Why do comparison groups matter?
General statistical explanation: each contrast answers a particular question. A comparison of active and sham procedures can help distinguish the active-point regimen from the sham-point regimen, while a comparison with standard care alone concerns the complete addition of a device-based procedure to care as described. A sham group is not interchangeable with a no-intervention group, and results from one contrast cannot automatically be treated as results from another. The trial has three arms, but the registry record does not identify a formal hierarchy for the pairwise comparisons or report their estimates.
When more than one outcome or comparison is examined, the interpretation of statistical evidence can depend on how many tests were planned and which results are treated as confirmatory. General statistical explanation: multiplicity refers to the increased chance of obtaining a seemingly notable result when many hypotheses are tested. It can be addressed through prespecified procedures, or the analyses can be labeled exploratory, but the appropriate approach depends on the study plan. The multiplicity strategy is not reported in the registry record.
What can be said about sample-size planning?
General statistical explanation: a sample-size calculation is a planning exercise based on assumptions about an effect, variability, significance level, allocation, and analysis method. It is not a measurement of the study’s actual statistical power after the data are collected. A planning illustration based on an observed effect is especially dependent on that effect estimate; it does not establish that the trial was originally designed around that effect.
The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. These are planning-illustration assumptions, not evidence of the trial’s original design justification. The trial’s own sample-size justification is not reported in the registry record. Since the primary outcome results are not reported, the observed effect used for any such illustration cannot be evaluated from the registry record. The enrollment of 171 should not be interpreted as proof that the study had adequate power for any particular contrast.
Why are analysis details essential?
General statistical explanation: statistical conclusions depend not only on the outcome instrument but also on how observations were included and modeled. For a change outcome, details such as whether the analysis compared change scores or adjusted for baseline values can affect the estimate and its precision. The handling of repeated observations, deviations from assigned treatment, and incomplete assessments can also matter. The registry record does not report the method used for the primary analysis, any covariate adjustment, or a detailed protocol for handling deviations.
Over-dispersion is a general concern when count data vary more than a model’s assumptions allow; it can make uncertainty estimates unreliable if ignored. It is not directly the defining issue for the reported primary endpoint, which is a continuous mean score. More generally, each statistical model has assumptions matched to its outcome type, and those assumptions should be assessed or described rather than inferred from a trial’s design label. The model assumptions and diagnostics for this primary outcome are not reported in the registry record.
Finally, a distinction is needed between statistical evidence and substantive importance. A small p-value, if one were reported, would not by itself show that a difference is large or meaningful. A confidence interval, if reported, would help indicate precision but would not resolve every question about measurement, missingness, masking, or generalizability. Because the primary estimates and analysis details are absent, these considerations remain guidance for interpreting a complete results record rather than conclusions about the outcomes of this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures and names changes in quality of life and sleep quality at week 6 and up to week 24 among the secondary outcomes. It identifies change in fatigue at week 6 as the primary outcome. The record does not give a complete statistical analysis plan, explain how the primary comparisons were prioritized, or describe any adjustment for multiple outcomes or pairwise comparisons. The multiplicity strategy is not reported in the registry record.
General statistical explanation: when several outcomes or comparisons are tested, the chance of at least one apparently notable result can increase. Interpretation is clearer when the primary hypothesis, secondary questions, and any adjustment procedure are prespecified. Without those details, readers cannot determine how the trial’s inferential claims were intended to account for multiple testing. No multiplicity-adjusted or unadjusted primary result is reported in the registry record.
The primary population is described as evaluable patients at week 6. The number of participants included in that population, the number with missing week-six assessments, and the reasons for missingness are not reported in the registry record. The record also does not state whether analyses followed assignment regardless of adherence, included only participants who completed treatment, or used another analysis population. Those distinctions can affect how a treatment comparison should be understood.
General statistical explanation: missing outcome data can reduce precision and can also introduce bias if the participants with observed measurements differ systematically from those without them. Statistical methods for incomplete data rely on assumptions, so the method and assumptions should be described. No missing-data method, sensitivity analysis, or analysis-population definition beyond “evaluable patients at week 6” is reported in the registry record. The available record therefore does not support a judgment about the impact of missing outcomes or the robustness of the primary analysis.
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 |
|---|---|---|---|
| Acupressure Plus Standard of Care | 0 | 53 | 0.0% |
| Sham Acupressure Plus Standard of Care | 1 | 56 | 1.8% |
| Standard of Care | 0 | 51 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Acupressure Plus Standard of Care | 0 of 53 |
| Sham Acupressure Plus Standard of Care | 0 of 56 |
| Standard of Care | 0 of 51 |
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 |
|---|---|
| Acupressure Plus Standard of Care | 0 of 53 |
| Sham Acupressure Plus Standard of Care | 1 of 56 |
| Standard of Care | 0 of 51 |
Most frequent serious adverse event terms
| Event term | Organ system | Acupressure Plus Standard of Care | Sham Acupressure Plus Standard of Care | Standard of Care |
|---|---|---|---|---|
| Guillain-Barré syndrome (GBS) | Infections and infestations | 0 of 53 | 1 of 56 | 0 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Acupressure Plus Standard of Care | Sham Acupressure Plus Standard of Care | Standard of Care |
|---|---|---|---|---|
| rheumatoid arthritis | Musculoskeletal and connective tissue disorders | 0 of 53 | 1 of 56 | 0 of 51 |
Serious events with the highest arm-level rate: guillain-barré syndrome (gbs) (1.8%).
The safety record gives group-specific counts for participants at risk and participants affected. For serious adverse events, the listed counts are 0 of 53 in the acupressure plus standard-of-care group, 1 of 56 in the sham-acupressure plus standard-of-care group, and 0 of 51 in the standard-of-care group. For other adverse events, the counts are 0 of 53, 1 of 56, and 0 of 51, respectively. Deaths are listed as 0 in all three groups.
These are observed counts in the recorded groups. They do not, by themselves, establish that an event was caused by an intervention, and the registry record does not report event-level causal assessments. A count of zero means no affected participants were listed in that group for the specified category; it does not establish that the risk is absent. With relatively limited counts, the record alone cannot characterize uncommon harms precisely.
Guillain-Barré syndrome (GBS) is listed as the top serious adverse event term, at 1.8%. The registry record does not supply additional clinical detail about that event in the registry record. Adverse-event counts should be interpreted alongside the time under observation, collection procedures, severity definitions, and attribution methods; those details are not reported in the registry record. The counts are descriptive safety information, not a comparison establishing a treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed randomized trial with three groups and a defined primary fatigue outcome. It describes the BFI, the baseline-to-week-six timeframe, and the population as evaluable patients at week 6. It also records selected secondary outcomes and group-level adverse-event counts. These details establish what was studied and what some of the planned measurements represent.
The record does not report the primary outcome values or statistical comparisons. It therefore cannot establish whether average fatigue changed within any group, whether changes differed between groups, or how precise any estimated difference was. It also cannot establish whether a finding was statistically significant or clinically important. The BFI scoring description and the threshold identified as clinically significant do not substitute for observed results.
Nor does the absence of efficacy results mean that the interventions had no effect. An unreported estimate may be favorable, unfavorable, or close to no difference; without the results, the registry record does not distinguish among those possibilities. Similarly, the safety counts are not sufficient to establish that an intervention caused or prevented an adverse event, or that no other safety concerns occurred.
General statistical explanation: a trial’s conclusion depends on the size and precision of its estimates, the analysis population, missing-data handling, the prespecified comparisons, and the credibility of the measurement process. Randomization is important but cannot compensate for absent outcome results. The design and endpoint description support understanding of the question, not a conclusion about the answer.
The proper scope of interpretation is consequently limited to the design and information recorded. The registry record does not report the sample-size justification, detailed analysis plan, or the primary results. Without those items, readers cannot assess the strength of evidence for the primary question or evaluate how sensitivity to analysis choices might affect the findings.
13. Why This Trial Matters Statistically
This trial is statistically notable for posing a three-arm comparison around a self-administered acupressure approach, a sham approach, and standard care alone. The arm structure separates questions that should not be conflated: active versus sham, active versus standard care, and sham versus standard care. A clear interpretation depends on knowing which contrasts were designated in advance and how each was analyzed; those details and the results are not reported in the registry record.
The primary endpoint also illustrates the distinction between describing a measurement and reporting evidence about it. The registry gives the BFI scale, its score categories, the clinical-significance threshold, and the timing of the primary assessment. Such definitions help readers understand what a result would represent. But without observed changes, between-group estimates, and confidence intervals, the endpoint cannot support an inference about comparative outcomes.
The listed evaluable-patient population raises a practical statistical question about who contributed data at week 6. A complete account of participant flow and missing assessments would help readers judge whether the analyzed sample reflects the randomized groups. The record does not give that information. This matters because randomized assignment and analysis of available measurements are not necessarily equivalent ways of defining a treatment comparison.
The safety counts offer a further example of why descriptive data require careful framing. Counts are useful for seeing what was recorded in each arm, but they are not causal estimates and do not precisely characterize rare events. Taken together, the record is useful for understanding the study’s design and outcome definitions, while its missing outcome estimates sharply limit statistical interpretation.
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 central limitation for interpretation is that the registry record does not report numerical results for the primary fatigue outcome. No arm-specific mean changes, between-group effects, confidence intervals, or p-values are recorded. This prevents assessment of both the direction and precision of the primary comparison.
The stated primary population is evaluable patients at week 6, but the record does not report how many participants were evaluable, how many lacked outcome data, or why assessments were missing. The definition of evaluability and the approach to incomplete data are not reported in the registry record. As a result, the extent and possible consequences of missing primary outcomes cannot be assessed.
Although masking is listed as quadruple, the roles masked and the methods used are not described. The record does not report whether masking was maintained or whether participants’ expectations were assessed. These details are pertinent to a self-reported outcome, but their absence does not establish that masking failed.
The registry does not report a detailed statistical analysis plan, the intended hierarchy of comparisons, a multiplicity strategy, or the model used for the primary outcome. It also does not report the trial’s sample-size justification. These omissions make it difficult to assess whether the planned analysis aligns with the three-arm design and the set of listed outcomes.
Finally, the adverse-event information is limited to counts, with no additional event-level detail or causal assessments reported in the registry record. The listed safety figures should therefore be read descriptively. These limitations concern what can be concluded from the recorded information; they do not establish that the trial itself lacked appropriate procedures or that unreported analyses were not conducted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Acupressure for Fatigue in Ovarian Cancer Survivors — NCT03763838.
- Registry record last updated 2026-02-05; status last verified 2026-01.
- Results first posted 2026-02-05.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03763838 is a completed, randomized, parallel-group trial titled “Acupressure for Fatigue in Ovarian Cancer Survivors.” The registry lists an enrollment of 171 and quadruple masking. The three groups were acupressure plus standard of care, sham acupressure plus standard of care, and standard of care alone.
The primary outcome was change in BFI fatigue level from baseline to week 6 among evaluable patients at week 6. The record describes the instrument but does not report the primary outcome results or statistical comparisons. Quality-of-life and sleep-quality changes are listed as secondary outcomes. The record also reports serious and other adverse-event counts and zero deaths in each group.
The design and measurement definitions clarify the questions the trial addressed, but the absence of primary estimates, analysis details, and information about missing outcomes means comparative fatigue results cannot be interpreted from the registry record.