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 The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients (NCT00825682), a non-randomized phase 1, phase 2 study. The primary outcome is The Lee Fatigue Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00825682 |
| Phase | Phase 1, Phase 2 |
| Condition | Fatigue |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 72 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sheba Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Women with breast cancer scheduled to receive adjunctive radiation treatment. The primary outcome description says the final analysis included 33 women in the experimental group and 20 in the control group. The registry record does not report further eligibility criteria or participant characteristics.
Intervention
Reflexology initiated at the beginning of radiation therapy, once a week for 10 weeks, according to the arm description. The study aimed to assess fatigue, quality of life and quality of sleep during and after radiation therapy.
Comparator
Treatment as usual, with participants matched by age to the intervention group according to the arm description. The comparison was non-randomized, so matching by age does not establish that the groups were alike in other respects.
Primary question
How did Lee Fatigue Scale scores change over the study time points, and how did those scores compare between the reflexology and control groups? The recorded time points were study beginning, 5 weeks after start and 10 weeks after start. The registry record does not report the resulting scores or a comparison between groups.
3. Trial Design
NCT00825682 is registered as a completed pilot study at Sheba Medical Center. Its listed phases are PHASE1 and PHASE2. The study used a parallel-group model, non-randomized allocation and no masking. The registry record reports enrollment of 72 participants, while the arm descriptions each describe a planned group of 20 women. The primary outcome entry says the final analysis included 33 women in the experimental group and 20 in the control group. These different counts describe distinct record entries; the registry record does not explain the difference.
The intervention group was to receive reflexology once a week for 10 weeks, beginning with radiation therapy. The control group was to receive treatment as usual and was matched by age to the intervention group. Because allocation was not randomized, measured and unmeasured differences between groups may influence any observed comparison. Age matching addresses only the characteristic identified in the record and does not ensure balance in other prognostic factors.
The primary outcome was the Lee Fatigue Scale, measured at the beginning of the study, 5 weeks after start, and 10 weeks after start. Listed secondary outcomes were quality of life measured with the Multidimensional Quality of Life Scale Cancer MQOLS-CA and sleep disturbance measured with the General Sleep Disturbance Scale. The registry lists 3 outcome measures, but reports 0 analyses. Numerical outcome results, group-level estimates, and details of how repeated measurements were analyzed 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: Exclusion criteria: breast cancer patients with metastatic lesions on lower limbs, coagulation disorders and patients receiving other contact treatments.
Overall Study
| Stage | Reflexology Group | Control Group |
|---|---|---|
| STARTED | 47 | 25 |
| COMPLETED | 34 | 20 |
| NOT COMPLETED | 13 | 5 |
Reasons for not completing this period:
| Reason | Reflexology Group | Control Group |
|---|---|---|
| personal reasons/ inconvenience | 13 | 5 |
Analysis population for the primary outcome, as defined in the registry: The final analysis included 33 women in the experimental group and 20 in the control group.
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 | Reflexology Group | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 47 | 25 | 72 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 39 | 22 | 61 |
| Age, Categorical: >=65 years | Participants | 8 | 3 | 11 |
| Age, Continuous | years | 56 (SD 9.47) | 52.3 (SD 11.78) | 54.6 (SD 10.4) |
| Sex: Female, Male: Female | Participants | 47 | 25 | 72 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: Israel | participants | 47 | 25 | 72 |
6. Primary Endpoint
The registry lists the primary outcome as The Lee Fatigue Scale, measured over Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the Lee Fatigue Scale, a continuous measure reported as a mean with standard deviation. Its 18 items cover fatigue and energy: 13 items contribute to the fatigue subscale and 5 to the energy subscale. The subscale means range from 0-10. Energy items were recoded to create a total score calculated as the average of all 18 items, also ranging from 0 to 10. Higher total scores indicate higher levels of fatigue.
Repeated measurement at the beginning of the study, 5 weeks after start and 10 weeks after start was intended to describe fatigue during and after radiation therapy and the reflexology schedule. Following a measure over time can help characterize whether scores change during the study, while a comparison group can provide context for those changes. In a non-randomized study, however, differences between groups may reflect factors other than the intervention.
The record notes that the English version has a Cronbach's Alpha reliability coefficient of 0.77 and states that the questionnaire's validity and reliability have been established in cancer patients. These details describe the instrument, not the study's results. The registry record does not report mean fatigue scores, standard deviations, changes over time, or an estimated group contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinical question about fatigue during and after radiation therapy, but it does not provide numerical results for the primary endpoint. No group means, standard deviations, change estimates, confidence intervals or p-values are reported. Therefore, the direction, size and precision of any fatigue difference cannot be assessed from the recorded results. The absence of reported estimates is not evidence that the groups had identical outcomes.
The design also limits what a group comparison could establish. Participants were not randomly allocated, and the control group was described as matched by age. In a non-randomized comparison, observed differences may arise from baseline characteristics, treatment choices, patterns of care or other factors in addition to the intervention. Age matching does not remove those other possible sources of confounding. The registry record does not report adjustment methods or baseline outcome values.
The record gives several distinct participant counts: overall enrollment of 72; planned groups of 20 in the arm descriptions; final analysis counts of 33 in the experimental group and 20 in the control group; and adverse-event risk counts of 47 and 25. These counts have different stated contexts. The registry record does not explain how they relate, so they should not be treated as interchangeable denominators or used to infer participant flow.
Although the study is marked completed, completion status alone does not establish that outcomes were analyzed or posted. The registry lists 0 analyses. It also lists quality of life and sleep disturbance as secondary outcomes but gives no numerical results for them. Consequently, the record supports a description of the study question, design and outcome definitions, but not a quantitative conclusion about fatigue, quality of life or sleep.
Any sample-size planning illustration should be distinguished from an observed treatment effect or a trial result. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Numerical planning estimates are not reported in the registry record, and no observed effect estimate is reported there from which to judge the illustration. Such planning quantities do not show that the study had a particular probability of detecting an effect.
9. Statistical Methods Explained
The primary outcome is continuous: each participant's Lee Fatigue Scale total is a numerical score. The registry describes the outcome using a mean and standard deviation. A mean gives the average score in a group, while a standard deviation describes how spread out individual scores are around that average. These summaries are useful for describing a continuous measure, but neither can be interpreted for this study because the outcome values are not reported in the registry record.
What would a group comparison represent?
A comparison of average scores between groups would describe the observed difference in fatigue scores under the study's non-randomized allocation. It would not, by itself, establish that reflexology caused any difference. Participants were not randomly assigned, and the registry describes age matching only. Other differences between groups could affect scores. An adjusted analysis could address specified measured factors, but the registry record does not report whether such an analysis was conducted or which factors it might have included.
How should repeated measurements be understood?
The Lee Fatigue Scale was scheduled at three points: the beginning of the study, 5 weeks after start and 10 weeks after start. Repeated measurements can be summarized as scores at each time point, changes within each group, or a comparison of patterns over time between groups. These approaches answer related but different questions. A change within one group does not alone establish a difference between groups. The registry record does not report the numerical scores or specify the statistical method used for repeated observations.
What does a confidence interval add?
In general, a confidence interval describes the uncertainty around an estimated quantity, such as a mean difference. A narrower interval indicates greater precision under the assumptions of the analysis; a wider interval indicates less precision. Its interpretation depends on the analysis design and assumptions. No confidence interval or estimate for the fatigue comparison is reported in the registry record, so precision cannot be evaluated.
What does a p-value address?
In general, a p-value measures how compatible the observed data are with a specified statistical null model, assuming that model and the analysis assumptions hold. It does not measure the size or clinical importance of an effect, and it does not remove bias from non-randomized allocation. No p-value for the primary outcome is reported in the registry record.
Why does over-dispersion matter?
General explanation: over-dispersion occurs when variability in data is greater than a statistical model assumes. If a model underestimates variability, its uncertainty estimates can be too small and statistical evidence can appear stronger than warranted. The recorded primary outcome is a continuous score summarized by a mean and standard deviation, and the registry record does not report a model or an assessment of over-dispersion. It is therefore not possible to say whether this issue was relevant to the analysis.
How should planning calculations be read?
General explanation: sample-size calculations describe how many participants an assumed design might require to detect a specified effect under stated assumptions. They are planning illustrations, not observed results and not a measure of the probability that a completed study detected an effect. The registry's stated assumptions are a two-sided significance level of 0.05, equal allocation, a normal approximation and an effect set to a stated fraction of the observed effect. Numerical planning estimates are not reported in the registry record. The record also does not report the trial's own sample-size justification, so the illustration should not be taken as evidence of the rationale used to plan the study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, the Lee Fatigue Scale, and two secondary outcomes: the Multidimensional Quality of Life Scale Cancer MQOLS-CA and the General Sleep Disturbance Scale. The primary measure was scheduled at three time points. Considering multiple outcomes or time points can raise a multiplicity issue: when many statistical comparisons are made, the chance of at least one apparently unusual result can increase. In general, an analysis plan may address this by identifying a primary comparison in advance or using an adjustment. The registry record does not report a multiplicity strategy, a prespecified primary time-point contrast, or numerical analyses for these outcomes.
The registry lists 0 analyses. It does not report outcome estimates, p-values, confidence intervals, or a description of missing outcome data. The amount and pattern of missing primary or secondary measurements are therefore not reported in the registry record. There is also no reported method for handling missing observations, such as whether analyses used available measurements or an imputation procedure.
The final analysis population is stated as 33 women in the experimental group and 20 in the control group. The arm descriptions refer to 20 women in each planned group, while overall enrollment is 72. The record does not provide a participant-flow account explaining these counts, exclusions, or whether every participant contributed measurements at every time point. It also does not describe an intention-to-treat population or another analysis-population definition. These omissions make it difficult to assess selection into the analysis and the completeness of follow-up.
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 |
|---|---|---|---|
| Reflexology Group | 0 | 47 | 0.0% |
| Control Group | 0 | 25 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Reflexology Group | 0 of 47 |
| Control Group | 0 of 25 |
The adverse-event entries report 0 serious events among 47 participants at risk in the reflexology group and 0 among 25 participants at risk in the control group. The entries also report 0 other events in each group, with the same respective at-risk counts. These are the figures recorded for the adverse-event categories; they do not establish that no events occurred outside the categories or reporting period represented in the record.
Deaths are listed as null for both groups, so death counts are not reported in the registry record. The record does not provide definitions, event collection procedures, observation duration for safety, or a narrative describing how events were assessed. The adverse-event at-risk counts differ from the final analysis counts for the primary outcome, and the registry does not explain the relationship between these populations. Accordingly, the safety entries should be read as registry reporting, not as a complete characterization of risk or as evidence that the groups had equivalent safety outcomes.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed, non-randomized, parallel-group pilot study was registered to examine reflexology during radiation therapy in women with breast cancer. It identifies a primary fatigue scale, three planned measurement times and secondary measures of quality of life and sleep disturbance. It also describes treatment as usual as the comparison and age matching as the basis for matching participants.
It does not establish the size or direction of any difference in fatigue, quality of life or sleep. The registry record reports no numerical outcome results and lists 0 analyses. Without estimates and measures of uncertainty, the magnitude and precision of a group comparison cannot be evaluated. Completion status and the stated study aim are not substitutes for posted results.
The non-randomized design means that even a reported difference would need cautious interpretation. Age matching does not guarantee balance in other characteristics, and the record does not describe an adjusted analysis. The different participant counts in the enrollment, arm descriptions, primary outcome population and safety entries are not reconciled in the registry record, so they should not be used to infer attrition or outcome completeness.
The study's pilot designation and planning assumptions do not demonstrate that any effect was present or that an effect was absent. They also do not establish the adequacy of the study to detect a particular difference. The record supports a description of what the investigators set out to measure and how the groups were organized, but not a conclusion about treatment efficacy or comparative benefit.
13. Why This Trial Matters Statistically
This study is statistically notable as a non-randomized comparison of a repeated continuous fatigue measure during and after radiation therapy. Its record illustrates why study design, outcome definition and outcome results need to be read separately. A specified scale and schedule tell readers what investigators intended to measure; without analyzed scores and uncertainty estimates, they do not reveal the observed pattern.
The age-matched control group offers a comparator, but non-randomized allocation leaves potential for confounding. In general, matching can improve comparability on the characteristic used for matching, but cannot ensure balance on other factors. Any causal interpretation would depend on design and analysis details that are not reported in the registry record.
The record also presents several participant counts in different contexts, without explaining how they connect. Recognizing that distinction is important: enrollment, planned arm size, outcome-analysis population and safety risk population need not be identical, but a transparent flow account helps readers understand who contributed to each result. Such an account is not reported in the registry record.
Finally, this record shows the difference between registering outcomes and posting analyses. Fatigue, quality of life and sleep are all identified as study aims or measures, yet numerical outcomes are not reported. Statistical interpretation requires the observed estimates, their uncertainty, and the analysis population and methods. Without those elements, the study can be described methodologically, but its comparative findings cannot be evaluated.
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.
Important design and reporting limitations specific to this study include non-randomized allocation and no masking. The control participants were described as matched by age, but no further matching factors or baseline comparisons are reported. The registry record does not describe whether outcome assessors were masked, how reflexology sessions were delivered or monitored, or whether participants received other interventions that could influence fatigue.
The participant counts are not reconciled: overall enrollment is 72, each arm description refers to 20 planned participants, the primary outcome population is 33 in the experimental group and 20 in the control group, and the safety entries give at-risk counts of 47 and 25. The registry record does not explain these differences or provide participant flow, reasons for exclusion, or completion by measurement time. This limits interpretation of the analysis population and missingness.
No numerical primary or secondary outcome results are reported, and the registry lists 0 analyses. Consequently, effect size, precision, statistical significance and the pattern of scores over time cannot be assessed. The analysis method, handling of repeated measures, missing-data approach, adjustment for potential confounders and multiplicity strategy are not reported in the registry record. The record also does not report the trial's own sample-size justification. These gaps restrict both statistical evaluation and interpretation of the study's findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients — NCT00825682.
- Registry record last updated 2016-12-08; status last verified 2016-10.
- Results first posted 2016-12-08.
- 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
NCT00825682 is a completed pilot study sponsored by Sheba Medical Center. It used a non-randomized, parallel-group design without masking. The intervention was weekly reflexology for 10 weeks beginning with radiation therapy; the comparator was treatment as usual, with age matching described. The primary outcome was the Lee Fatigue Scale, scheduled at the beginning of the study, 5 weeks after start and 10 weeks after start. Listed secondary outcomes assessed quality of life and sleep disturbance.
The registry record reports enrollment of 72 and a primary outcome analysis population of 33 women in the experimental group and 20 in the control group, but does not reconcile those counts with the arm descriptions or safety populations. It lists 0 analyses and reports no numerical outcome results. Thus, the design and planned measures can be described, but the comparative results and their precision cannot be evaluated from the registry record.