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 Yoga to Alleviate Fatigue, Anxiety and Pain in Adolescents During Treatment for Lymphoma or Leukemia (NCT02473523), a na na study. The primary outcome is Rate of Patients Who Are Willing to Participate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02473523 |
| Phase | NA |
| Condition | Leukemia, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin's |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | St. Jude Children's Research Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Adolescents receiving treatment for leukemia, Hodgkin lymphoma, or non-Hodgkin lymphoma who met the study’s eligibility requirements and consented to participate. The registry does not give further age or eligibility details in the posted arm description.
Intervention
Yoga therapy, with measures named for fatigue, quality of life, pain, and physical performance. The registry describes the primary objective as determining whether a yoga intervention is feasible during lymphoma and leukemia treatment.
Comparator
There is no separate comparator group. The trial is registered as single-group, with allocation listed as NA and masking listed as none. It therefore does not provide a like-for-like comparison with usual care or another intervention.
Primary question
What rate of patients approached would be willing to participate? The registry defines the measure as the number willing relative to the total approached. It also describes pilot data collection about yoga and pain, quality of life, fatigue, and physical performance; these are not the primary feasibility question.
The clinical question is primarily about implementation and acceptability rather than a comparative estimate of treatment effect. The registry description anticipates that 50% of approached patients would agree and says 25 patients would be approached. It also states that if more than 6 of those approached refuse, the study would close and be considered not feasible. These are stated expectations and a decision rule, not reported findings. Enrollment was 2, but the registry does not report how many patients were approached, how many agreed, or the observed willingness rate. Consequently, the posted record does not establish whether the feasibility criterion was met.
3. Trial Design
NCT02473523 is registered as a single-group study of yoga for adolescents receiving treatment for leukemia or lymphoma. The listed conditions are leukemia, Hodgkin lymphoma, and non-Hodgkin lymphoma. The sponsor is St. Jude Children's Research Hospital. The phase and allocation are listed as NA, and masking is listed as none. There is no registered control arm, so the design is not a randomized or controlled comparison.
The registry lists enrollment of 2, a study start of 2015-06, a primary completion date of 2016-12, and status as terminated. The reason for termination is not reported in the registry record. The primary objective is feasibility. The description says that 25 patients would be approached and sets a refusal threshold for stopping, while anticipating that 50% would agree to participate. Those protocol statements should not be read as observed recruitment or consent results.
Yoga therapy is listed alongside measures or devices including the PedsQL Cancer Module, PedsQL Multidimensional Fatigue Scale, Verbal Numeric Pain Scale, Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency. The record lists 16 outcome measures, but does not report results for them. The record also lists 0 analyses. No detailed statistical analysis plan, participant flow, or explanation of the discrepancy between the planned approach target and enrollment is reported in the registry record.
Because there is no comparison group, changes observed within participants, if reported, would not by themselves separate intervention-associated change from other influences over time. In this record, even within-participant outcome estimates are not posted. The available design and enrollment information therefore supports a description of the study’s intent and structure, not an estimate of comparative effectiveness.
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 | Participants |
|---|---|
| STARTED | 2 |
| COMPLETED | 0 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Participants |
|---|---|
| Death | 1 |
| Lost to Follow-up | 1 |
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 | Participants |
|---|---|---|
| Participants analysed | 0 | |
| Gender: Female | — | |
| Gender: Male | — |
6. Primary Endpoint
The registry lists the primary outcome as Rate of Patients Who Are Willing to Participate, measured over Day 0.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the rate of patients willing to participate, defined in the registry as the number willing divided by the total number approached. It is assessed at Day 0. This endpoint addresses whether eligible adolescents approached about the study would agree to take part, an implementation question relevant to the feasibility objective. It is distinct from an outcome such as change in fatigue, pain, quality of life, or physical performance.
The registry description anticipates that 50% of approached patients will agree, states that 25 patients will be approached, and specifies that the study would close if more than 6 refuse. These are the study’s stated expectations and decision rule. The observed number approached, number willing, number refusing, and resulting rate are not reported in the registry record. Enrollment of 2 is not a substitute for those quantities: enrollment alone does not identify the number approached or the willingness rate.
A willingness rate is interpretable only with its denominator and a clear account of who was approached and how willingness was determined. If some approached patients had an unknown response, that status would also matter to interpretation; how such cases were handled is not reported in the registry record. Without the observed counts, the primary endpoint cannot be evaluated against the stated feasibility expectation or stopping rule.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry states a feasibility aim and a specific primary measure: willingness to participate among patients approached. It also provides an anticipated agreement rate of 50%, a plan to approach 25 patients, and a rule to stop if more than 6 refuse. These details identify what the investigators intended to assess. They do not show whether the study met its feasibility criterion, because the observed approach and response counts are not reported in the registry record.
Enrollment was 2, and the registered status is terminated. These registry entries indicate that the posted study record contains a small enrollment and a termination status, but they do not explain why the study ended. The reason for termination is not reported in the registry record. It would therefore be inappropriate to attribute termination to recruitment difficulty, safety, intervention delivery, or any other particular cause. The record also does not say whether the planned number approached was reached.
The study included a stated pilot objective concerning pain, quality of life, fatigue, and physical performance. The registry names relevant measures, including the PedsQL instruments, pain scale, and physical performance tests. However, outcome results are not reported in the registry record, and the record lists 0 analyses. No change estimates, uncertainty intervals, or hypothesis-test results are available in the posted record. Thus, the registry does not allow readers to quantify the direction or precision of any outcome changes.
Even if within-participant outcome values were available, the single-group design would not provide a concurrent comparison for distinguishing intervention-associated changes from changes that might occur for other reasons. The absence of a comparator is a design feature, not evidence for or against an effect. The posted data therefore do not support a comparative conclusion about yoga.
The primary endpoint is also distinct from the clinical outcomes. A favorable willingness rate, if one had been reported, would address participation and implementation, not establish improvement in symptoms or function. Conversely, the absence of a posted willingness rate means the stated feasibility question remains unanswered by this registry record. The most defensible reading is that the record documents the study’s intended feasibility assessment, its small enrollment, and its termination status, while leaving the principal observed outcomes and the reason for termination unreported.
9. Statistical Methods Explained
The registry frames the primary objective as feasibility and defines the main measure as willingness among patients approached. The record does not report an inferential statistical plan. The explanations below describe general statistical concepts relevant to interpreting this type of study; they are not a claim about analyses performed in this trial.
What does a willingness rate represent?
In general, a rate of willingness is a proportion: the number who agree is the numerator, and the number approached is the denominator. Both counts are needed to interpret the result. The same numerator can imply different rates under different denominators, and the number enrolled alone does not reveal either the approach count or the rate. For this study, the registry reports enrollment of 2 but does not report the observed number approached or willing. The observed primary endpoint therefore cannot be reconstructed from the posted information.
The stated expectation of 50% and the plan to approach 25 patients describe the intended assessment. The rule that the study would close if more than 6 refuse is a decision threshold in the registry description. A threshold can guide a feasibility decision, but it is not an observed result. Since the actual refusal count is not reported in the registry record, the decision rule cannot be applied to the posted data.
Why would an interval matter for a proportion?
In general, a confidence interval expresses uncertainty around an estimated quantity under a statistical model. For a participation proportion, the interval would convey how imprecisely the observed willingness rate is estimated. A rate based on limited observations will generally be less precise than one based on more observations, although the exact interval depends on the data and method. No willingness estimate or confidence interval is reported in the registry record, so no precision assessment is available for the primary endpoint.
What can a single-group study estimate?
In general, a single-group study can describe measured outcomes among participants over time if those measurements and their analysis are reported. Without a concurrent comparison group, it cannot directly estimate how those outcomes would have differed under another treatment or usual care. Changes may coincide with an intervention without establishing that the intervention caused them. This distinction matters for the pilot outcomes named in the registry: pain, quality of life, fatigue, and physical performance. The registry does not post the corresponding outcome results, so neither within-group change nor comparative effects can be quantified.
How should sample-size illustrations be understood?
In general, a planning calculation asks how many observations might be needed to detect an assumed effect under specified statistical assumptions. It is not an observed trial result and does not describe the study’s achieved power. Any planning illustration based on an observed effect is especially dependent on the effect estimate used. The posted record does not report outcome effect estimates that would support interpreting such an illustration as evidence about this study’s outcomes.
The planning assumptions associated with the calculations describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and detection of a stated fraction of an observed effect. Those assumptions do not match the registered single-group design, which has no two-arm allocation. Such a calculation should therefore be understood as a hypothetical planning exercise rather than a description of the registered design. It is not an observed-power calculation and cannot fill the gaps in the outcome record.
What does the analysis listing tell readers?
The registry lists 0 analyses and 16 outcome measures. In general, an outcome measure is a defined variable or assessment, whereas an analysis specifies how data are used to answer a question. Listing many measures does not itself show that results were analyzed or reported. The 0 analyses listing establishes that no analyses are listed in this record; it does not, on its own, establish what work may or may not have been conducted outside the registry. Statistical methods, adjusted estimates, and uncertainty measures are not reported in the registry record.
Over-dispersion is a general concern when count data vary more than a simple statistical model expects; it can make standard uncertainty estimates too small if ignored. No count-model analysis is described for this study, so over-dispersion is not a trial-specific finding. More broadly, the appropriate model depends on the outcome type and design. Without posted outcome data and a documented analysis plan, it is not possible to assess model choice, assumptions, or sensitivity of estimates in this record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 16 outcome measures, including the primary willingness endpoint and measures related to fatigue, quality of life, pain, and physical performance. The record does not report a hierarchy among the non-primary measures, a multiplicity adjustment, or a plan for choosing which outcomes would support formal conclusions. These details are not reported in the registry record. In general, testing or emphasizing many outcomes can increase the chance of finding apparently notable results by chance; a prespecified hierarchy or adjustment can help make interpretation more disciplined. Here, no outcome analyses or results are posted, so the effect of multiplicity on any findings cannot be assessed.
Missing-data methods are also not described. The record does not report completion counts for the named assessments, reasons for missing measurements, or any imputation or other missing-data procedure. In general, missingness can affect both the estimate and its uncertainty, particularly when the availability of measurements is related to participants’ outcomes or experiences. The posted record does not provide enough information to assess whether missing data occurred or how it was handled.
The analysis population is not reported in the registry record. In general, an analysis population specifies which participants contribute to a particular analysis and how events such as non-adherence or incomplete assessment are handled. This matters even in a single-group feasibility study because the people approached, enrolled, and assessed may not be identical sets. The registry lists enrollment of 2 but does not provide participant flow or endpoint-specific denominators. Accordingly, the relationship among approach, consent, enrollment, and outcome assessment cannot be reconstructed.
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 |
|---|---|---|---|
| Participants | 0 | 1 | 0.0% |
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 |
|---|---|
| Participants | 0 of 1 |
The posted adverse-event summary lists 1 participant at risk in the serious-event category and 0 affected. It also lists 1 participant at risk in the other-event category and 0 affected. The death count is not reported in the registry record. These figures describe the entries in the posted summary; they do not establish the completeness or duration of safety monitoring.
Enrollment is listed as 2, while the adverse-event summary has 1 participant at risk for each category. The registry does not explain the relationship between those counts, the observation period, or whether the at-risk count reflects the full enrolled group. The figures should therefore be read with their stated denominators rather than treated as a complete safety profile for all enrolled participants.
In general, zero affected participants in a posted summary is not proof that an event is impossible or that risk is absent. The precision of a safety estimate depends on the number monitored, event definitions, follow-up, and completeness of reporting. Those details are not reported in the registry record. The adverse-event entries do not establish a causal relationship to yoga, and no such inference is warranted from these counts alone.
12. What the Result Does, and Does Not, Mean
The record documents a study intended to assess whether yoga could be implemented for adolescents receiving treatment for leukemia or lymphoma. Its primary question concerned willingness to participate, with a stated expectation of 50%, a plan to approach 25 patients, and a stopping rule tied to refusals. Enrollment was 2, and the study status is terminated. These registry entries describe the registered study and its scale, but the observed willingness rate and the reason for termination are not reported in the registry record.
The record also describes pilot data collection for pain, quality of life, fatigue, and physical performance. It names assessment tools but posts no outcome results. Consequently, there is no reported estimate of change, no uncertainty interval, and no basis in this record for judging the magnitude or precision of any clinical outcome. The record lists 0 analyses, so no statistical result can be interpreted from an analysis listing.
The single-group design has no concurrent comparator. In general, such a design may describe participants’ measurements, but it cannot establish how results compare with another treatment or usual care. Moreover, no outcome values are posted. The design and the missing results jointly limit what can be concluded; neither should be converted into a claim that yoga did or did not produce benefit.
Feasibility and clinical effect are different questions. A reported willingness rate could inform whether recruitment and participation appeared workable under the study’s conditions, but it would not itself demonstrate changes in symptoms or function. Conversely, the pilot objective does not change the primary endpoint from willingness to participate. The registry record leaves both the observed feasibility result and the pilot outcome results unreported, so the intended questions cannot be answered from the posted data.
13. Why This Trial Matters Statistically
This study illustrates why the research question and endpoint need to be distinguished. Its primary endpoint concerns willingness among patients approached, while the broader clinical interest concerns pain, quality of life, fatigue, and physical performance. These questions require different data and support different interpretations. A participation measure addresses feasibility; it is not a substitute for a clinical outcome measure.
The registry also shows why denominators are essential. Enrollment of 2 does not reveal how many people were approached, how many agreed, or what proportion was willing. The stated plan and decision threshold make the intended feasibility assessment clear, but without observed counts they cannot establish whether the study met its criterion. A complete account of approach, response, enrollment, and assessment would be needed to interpret recruitment and participation.
Design structure matters as well. A single-group study can be useful for describing implementation and collecting pilot measurements, but it does not furnish a concurrent control comparison. Statistical interpretation must stay aligned with that structure; a hypothetical two-arm planning calculation does not turn a single-group study into a comparative trial. Planning illustrations are not observed power or outcome evidence.
Finally, the registry lists multiple outcome measures but does not provide analyses, results, a multiplicity plan, or missing-data details. This leaves readers unable to assess estimates, precision, selective emphasis among outcomes, or the handling of incomplete data. The record is therefore a useful example of how registration details can specify intent while the absence of posted results sharply limits what can be learned statistically.
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.
Several limitations specific to this record constrain interpretation. The study is single-group, with allocation listed as NA and no comparator. It cannot provide a controlled estimate of a difference between yoga and another approach. Enrollment is 2, and the registry does not report how many patients were approached, how many consented, or how many completed the assessments. As a result, even the primary participation rate cannot be evaluated.
The registered primary endpoint is a feasibility measure, but the result is not reported. The plan to approach 25 patients, the anticipated agreement rate of 50%, and the rule to close if more than 6 refuse do not supply the actual approach and refusal counts. The registered status is terminated, but the reason is not reported in the registry record. It is not possible to determine from the posted details whether the study ended because of recruitment, implementation, safety, or another issue.
Although 16 outcome measures are listed, no outcome results are posted and 0 analyses are listed. The statistical analysis plan, analysis populations, missing-data methods, and multiplicity approach are not reported in the registry record. The adverse-event summary contains limited at-risk and affected counts, without details about observation period or completeness. These gaps prevent assessment of outcome precision, safety ascertainment, and the robustness of any analyses. The limitations reflect the information in the registry record and should not be mistaken for proof that particular procedures were or were not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Yoga to Alleviate Fatigue, Anxiety and Pain in Adolescents During Treatment for Lymphoma or Leukemia — NCT02473523.
- Registry record last updated 2017-03-08; status last verified 2017-01.
- Results first posted 2017-03-08.
- 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.
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18. Record Summary
NCT02473523 registered a single-group yoga feasibility study for adolescents receiving treatment for leukemia, Hodgkin lymphoma, or non-Hodgkin lymphoma. The primary endpoint was the rate of patients willing to participate among those approached. The record states an anticipated agreement rate of 50%, a plan to approach 25 patients, and a stopping rule if more than 6 refuse. Enrollment was 2; status is terminated.
The registry lists 16 outcome measures and 0 analyses. Results for willingness, pain, quality of life, fatigue, and physical performance are not reported in the registry record. The reason for termination, detailed statistical methods, missing-data handling, and analysis populations are also not reported. The posted adverse-event summary lists 0 affected among 1 at risk in each of its serious and other event categories; the death count is not reported. The single-group design provides no concurrent comparator.