Body Mind Training Project: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Body Mind Training Project (NCT01564394), a randomized na study. The primary outcome is Retention Rate in Study (Feasibility Outcome).

2. Clinical Question

The clinical question therefore has two related but distinct parts. The primary outcome concerns whether survivors can be retained through the study’s post-intervention assessment. The broader research aim concerns whether Qigong merits further evaluation against a non-aerobic stretching control for fatigue and related outcomes. Retention is relevant to feasibility because a study can only collect later outcomes from participants who remain engaged and complete assessments. It is not itself a measure of fatigue improvement, quality of life, or treatment efficacy.

The stated hypothesis anticipated improved fatigue, quality of life, and related psychosocial and health outcomes in the Qigong group compared with stretching. Those are research aims rather than results. The registry record posts one secondary outcome, Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks, but does not provide its result in the information available for this analysis. Results for the other intended outcomes are not reported in the registry record.

3. Trial Design

The Body Mind Training Project is recorded as a randomized, single-masked, parallel-group behavioral study. Participants were assigned to Qigong or non-aerobic stretching, which the record labels Stretching Control. The record lists an enrollment of 60 and identifies the study as completed. The phase is listed as NA. The study start is recorded as 2011-10 and primary completion as 2012-09.

The intervention descriptions clarify the intended distinction between the groups. Qigong was described as a sequence of slow, flowing movements with concentration on breath and awareness. Stretching was intended as an attention control, with attention and group participation serving as non-specific features shared with the intervention experience. The registry says the study was single-masked but does not identify which people were masked or explain how masking was maintained. Details about the randomization sequence or concealment are not reported in the registry record.

The posted retention outcome gives an outcome count of 20.0 in each arm: 0.8 for Qigong and 0.65 for Stretching Control. The safety record separately lists 30 participants at risk in each group. These different arm counts are both present in the record, but the reason for the difference is not reported in the registry record. The overall enrollment figure should therefore not be treated as if it were the analysis denominator for every posted outcome.

The study’s stated aims included documenting participation, retention, adherence, reasons for participation and attrition, recruitment and retention strategies, satisfaction, perceptions, and study burden. It also sought preliminary data on fatigue, psychosocial outcomes, and health-related quality of life to inform a future larger trial. The registry record does not report a detailed protocol, the allocation procedures, or the statistical plan for those aims.

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: Out of 89 prostate cancer survivors screened for eligibility, forty were eligible and interested in participating in the study.Twenty family members met criteria for participating. Only the survivors were randomized to study arms. Family members attended the study arm that the survivor was randomized to.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Retention Rate in Study (Feasibility Outcome), measured over 13-weeks.

The primary endpoint is the retention rate at 13-weeks. It is defined as the proportion of participants who remained enrolled and completed post-intervention measures. The registry gives the measure a range from 0 to 1 and specifies that the retention and attendance calculations concern prostate cancer survivors rather than family members.

Retention is used as a feasibility outcome because it describes whether participants stayed involved through the planned post-intervention assessment. A higher observed proportion indicates that a larger share of the relevant enrolled group met that retention definition. It does not establish why participants remained or left, how much they attended, whether they adhered to the intervention, or whether their symptoms changed. Those questions require their own measures and analyses.

The posted arm-level retention values are 0.8 for Qigong and 0.65 for Stretching Control, each with an outcome count of 20.0. The record does not provide a confidence interval for either arm’s retention value. It also does not explain the distinction between these arm counts and the safety record’s 30 participants at risk per group.

Retention is relevant to deciding whether a future study can collect outcome data, but it is not a substitute for the planned clinical outcomes. The registry’s broader aims included fatigue and quality of life, while the primary posted endpoint is completion and continued enrollment. The endpoint therefore speaks directly to feasibility, not to the direction or size of an effect on fatigue or quality of life.

7. Results Posted in the Registry

• Qigong: 0.0% (0/20) versus 0.0% (0/20) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0); unadjusted two-proportion z-test p = n/a.

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is retention? Retention is a proportion: the numerator represents participants meeting the registry’s completion definition, and the denominator represents the relevant group. For this study, the definition requires that participants remain enrolled and complete post-intervention measures. A proportion is descriptive: it tells readers how common the defined outcome was in the recorded group. It does not, by itself, account for uncertainty or establish a causal explanation.

The posted values are 0.8 for Qigong and 0.65 for Stretching Control, with an outcome count of 20.0 in each arm. The registry does not give a confidence interval for either value. It is therefore possible to describe the observed proportions, but the precision of those estimates cannot be assessed from an interval reported in the record.

What would a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated quantity under a specified statistical method. For a proportion, it can help show the range of values that remain compatible with the observed data and that method’s assumptions. An interval is not a guarantee that the true value lies in a particular range, and its interpretation depends on the method and data structure. No interval for the retention proportions is reported in the registry record, so the uncertainty around each arm value is not quantified there.

How should a between-group contrast be assessed?

A group comparison should be based on a clearly defined estimand, the relevant analysis population, and a statistical method suited to the outcome and design. The record contains a comparison entry with a risk difference of 0.0 and limits of 0.0 and 0.0, but its accompanying zero-valued counts do not match the posted arm-level retention values. The record lists no analyses and does not explain this mismatch. Consequently, that entry cannot be treated as a coherent inferential comparison. No recalculated comparison is presented.

In general, comparing proportions may involve estimating a difference between groups and quantifying its uncertainty. The choice of method can depend on the sample sizes, missing outcome data, and prespecified analysis approach. Those details, including the intended method and any adjustment variables, are not reported in the registry record. The arm-level proportions remain descriptive rather than a substitute for a prespecified comparative analysis.

What does randomization contribute?

Random assignment is intended to make treatment groups comparable on average with respect to factors known and unknown at assignment. It supports a causal comparison when the allocation process is properly implemented and when outcomes are analyzed in a way consistent with the design. The record identifies the allocation as randomized but does not report sequence generation, allocation concealment, or the analysis population. It also does not identify who was masked, despite recording single masking. These missing design details constrain assessment of the protection against bias.

The parallel-group structure means that participants were assigned to one of the two intervention groups rather than crossing between them as part of the stated model. The interventions are behavioral, and the record describes the stretching group as an attention control. That control is intended to address non-specific features such as attention and group setting. The record does not report whether treatment fidelity, attendance, or adherence was analyzed, despite the stated feasibility aim of assessing adherence.

What is the role of sample-size planning?

In general, a sample-size calculation is a planning exercise that describes how many participants may be needed under specified assumptions about the effect to detect, the significance level, allocation, and statistical method. The registry’s sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects set as stated fractions of the observed effect. Time-to-event calculations are described as total event counts, while other calculations are described as participants per arm. These are planning assumptions, not observed results or evidence of achieved power.

The protocol’s original sample-size justification is not reported in the registry record. No sample-size planning estimates are described in the registry entries for this interpretation. Since the comparative retention entry is internally inconsistent with the arm-level values, no effect magnitude should be inferred from it for planning. A planning illustration should also not be mistaken for observed power, which is not an informative replacement for an interval estimate of a study result.

Are more complex statistical models indicated?

Over-dispersion matters in models that assume a particular amount of variability, especially when the observed data vary more than the model allows. General assessment of over-dispersion requires a model and suitable outcome data. The primary outcome is posted as arm-level proportions, and no model or analysis is reported; there is no basis in the registry record to assess over-dispersion. Likewise, the record does not report whether any adjustment for baseline factors, clustering, or repeated measurements was planned.

The principal statistical conclusion is therefore limited: the record provides two descriptive retention values, but it does not provide a coherent reported comparison or interval-based precision assessment. The further methodological details needed to support a formal test are not reported in the registry record.

10. Confidence Intervals and Precision

Precision concerns how much uncertainty surrounds an estimate. For retention, the registry reports 0.8 in the Qigong arm and 0.65 in the Stretching Control arm, with 20.0 listed for each outcome. It does not report a confidence interval around either proportion. Readers can identify the observed values, but cannot use the registry record to judge the interval-based uncertainty associated with them.

A confidence interval would generally communicate the range of estimates compatible with the observed data under a stated method. Its width depends on features such as the amount of information in the data and the statistical procedure. Because no interval is reported, a narrow or wide interval cannot be claimed. No precision claim should be inferred from the arm-level point estimates alone.

The registry also contains a comparative risk-difference entry of 0.0 with limits of 0.0 and 0.0. This entry is inconsistent with the arm-level proportions and is accompanied by zero-valued counts; it should not be used to describe precision or to conclude that the groups had identical retention. The record does not explain the discrepancy, and no analyses are listed.

The safety figures are also counts rather than interval estimates. The registry records zero serious adverse events and zero other adverse events among 30 at risk in each group. It does not report confidence intervals for those counts or additional detail that would quantify uncertainty. Such zero counts describe what was posted, not proof that the underlying risk is zero.

Overall, precision is limited by the absence of reported intervals and a coherent group comparison. The study’s preliminary feasibility framing is important: descriptive observations can inform planning, but they do not provide the same inferential detail as estimates accompanied by uncertainty measures and a transparent analysis plan.

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures and identifies one secondary outcome: Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks. It does not provide results for that secondary outcome in the information available for this analysis. Results for the other listed measures are not reported in the registry record. The record also lists no analyses, so it is not possible to determine which outcomes were analyzed or whether analyses were conducted but not posted.

Multiplicity arises when several outcomes, time points, or comparisons are tested. In general, testing many questions can increase the chance of at least one apparently notable finding by chance. A statistical plan may specify a primary outcome, a hierarchy, or an adjustment approach, but those details are not reported in the registry record. There is no basis to claim that a multiplicity correction was or was not performed.

The primary outcome has a defined completion-based meaning, but the registry does not report how missing outcome information was handled. It does not state whether participants without post-intervention measures were counted as not retained, excluded from a particular analysis, or treated using another approach beyond the endpoint’s stated retention definition. Further details on missing-data methods are not reported in the registry record.

The analysis population is not described. The record does not specify whether the intended analysis followed randomized assignment, included only participants who began the intervention, or used another population definition. It also does not report a protocol-level plan for handling departures from assigned intervention, adherence, or withdrawal. These omissions matter because analysis choices can affect interpretation, even when the endpoint itself is a straightforward proportion.

The posted arm counts for retention are 20.0 per group, while the safety record lists 30 participants at risk in each group. The reason for these distinct denominators is not reported in the registry record. This prevents readers from fully tracing which participants contributed to each outcome. The record’s comparison entry is also inconsistent with the arm-level retention values, and the registry does not explain the discrepancy. These limitations make a formal assessment of missingness, multiplicity, and analysis populations unavailable from the posted information.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The safety record lists 30 participants at risk in the Qigong group and 30 in Stretching Control. For each group, the posted count of serious adverse events is 0, and the count of other adverse events is also 0. No serious adverse event terms are listed. These figures describe the entries in the registry record; they do not establish that no adverse events occurred outside the information recorded there.

The deaths field is null for each group. A null entry is not the same as a reported count of zero, so deaths are not reported in the registry record. The registry does not provide additional event descriptions, timing, severity details, or a safety analysis in the information available for this interpretation.

Zero reported events in a finite group do not prove that the underlying event risk is zero. General interpretation of safety counts depends on the completeness of reporting, the definition and observation period for events, and the amount of follow-up. The record gives the at-risk counts but does not explain the safety reporting procedures or provide interval estimates. The figures should therefore be read as posted counts, not as a definitive demonstration of absence of harm.

The safety denominators differ from the 20.0 participants listed per arm for the retention outcome. The reason is not reported in the registry record. That distinction should be preserved when interpreting the safety counts rather than assuming that the same participants contributed to every outcome.

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

The primary posted result describes retention, not clinical benefit. The registry records retention proportions of 0.8 for Qigong and 0.65 for Stretching Control at 13-weeks, based on 20.0 listed participants per arm. Under the endpoint definition, retention means remaining enrolled and completing post-intervention measures. This information can help characterize whether study follow-up was achieved in the groups as recorded.

The figures do not establish that Qigong changed fatigue, quality of life, or psychosocial outcomes. Those outcomes formed part of the study’s aims, and the registry lists a BSI-18 change outcome, but results for those measures are not reported in the registry record. Retention also does not directly measure adherence, satisfaction, safety, or reasons for attrition. Although those topics were among the stated feasibility aims, corresponding findings are not reported in the information.

The record contains a comparison entry of 0.0 for the risk difference, with limits of 0.0 and 0.0, and zero-valued counts. That entry conflicts with the arm-level retention values. Because the registry lists no analyses and does not reconcile the mismatch, the entry cannot support a claim of no difference or a formal treatment comparison. No group effect should be calculated from the posted values for this interpretation.

The safety record reports no serious or other adverse events in either group among 30 at risk per group, while deaths are not reported. Those entries do not prove that event risk was absent. The record does not provide enough information to assess the completeness of safety surveillance or the precision of the event counts.

In general, a feasibility study can help determine whether recruitment, retention, intervention delivery, and assessment procedures warrant further evaluation. This record’s stated intention was to generate preliminary information for a future larger trial. The posted retention outcome is relevant to that aim, but the incomplete results and unresolved comparison entry limit the conclusions that can be drawn. No medical recommendation or claim about treatment efficacy follows from these data.

14. Why This Trial Matters Statistically

This study is statistically important because it distinguishes a feasibility outcome from the clinical outcomes that motivated the research. Retention is an operational measure of whether participants remained enrolled and completed post-intervention measures. That information can matter when planning a larger study: outcome data cannot be collected at a later assessment from participants who do not complete it. But retention is not a surrogate result for fatigue or quality of life, and it cannot answer the clinical hypothesis by itself.

The design also includes an active attention control rather than an absence of group contact. The registry describes stretching as a means of controlling for attention and group setting, while Qigong is described as a movement and awareness practice. This design can help frame a later comparison around the intervention content, but interpretation still depends on the actual allocation, masking, adherence, and analysis procedures. Several of those details are not reported in the registry record.

The posted outcomes illustrate why data consistency matters. The arm-level retention values are 0.8 and 0.65, yet the comparison entry reports a risk difference of 0.0 with zero-valued counts and limits. Without an explanation, the comparative entry cannot be reconciled with the descriptive results. Statistical interpretation depends not only on a point estimate but also on traceable denominators, a defined analysis, and an uncertainty measure.

The registry’s aims included recruitment, retention, adherence, perceptions, and study burden, as well as preliminary clinical outcomes. A transparent record of each measure and its analysis would help distinguish the operational lessons from any preliminary clinical signals. The information available supports a limited descriptive reading of retention and safety counts, while leaving many of the planned feasibility and clinical questions unanswered.

The project was explicitly framed as preparation for a larger definitive randomized trial. Its statistical contribution is therefore best considered in terms of the feasibility information it set out to gather and the reporting limitations that remain, not as a definitive evaluation of Qigong’s effects.

15. 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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The most direct limitation is that the primary outcome has no reported confidence interval, and the registry lists no analyses. The record provides arm-level retention values but does not give a coherent inferential comparison. Its comparison entry reports a risk difference of 0.0 with limits of 0.0 and 0.0, alongside zero-valued counts, which does not align with the arm-level values. The reason for this inconsistency is not reported in the registry record.

The outcome denominators also need careful distinction. Retention is posted with 20.0 participants per group, whereas the safety record lists 30 at risk per group. The registry does not explain why these denominators differ. The overall enrollment is 60, but the record does not provide participant flow details that would account for those figures or show how many participants were randomized, began each intervention, or completed each assessment.

The registry identifies the study as single-masked, but does not state who was masked or how masking was implemented. Random allocation is recorded, but the generation and concealment methods are not reported. The analysis population, handling of missing data, adherence analysis, and methods for the listed secondary outcomes are also not reported in the registry record. The record does not provide a protocol-level sample-size justification or explain any interim analyses.

Although the stated aims included fatigue, psychosocial outcomes, health-related quality of life, satisfaction, perceptions, and study burden, the results for these aims are not reported in the information available for this analysis. One secondary outcome is listed, but its result is not reported in the registry record. Consequently, the posted retention figures cannot resolve the broader research questions.

Finally, zero posted adverse-event counts should be interpreted as registry entries rather than proof of no risk. The deaths fields are null rather than zero, and event follow-up and reporting details are not reported. These gaps limit both the safety interpretation and the statistical assessment of uncertainty.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Body Mind Training Project — NCT01564394.
• Registry record last updated 2015-12-08; status last verified 2015-11.
• Results first posted 2015-08-19.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The Body Mind Training Project is recorded as a completed, randomized, single-masked, parallel behavioral study with enrollment of 60. It compared Qigong with non-aerobic stretching among elderly prostate cancer survivors, with the stretching group intended as an attention control. The study start is listed as 2011-10 and primary completion as 2012-09.

The primary outcome was retention at 13-weeks, defined as remaining enrolled and completing post-intervention measures. The posted values are 0.8 for Qigong and 0.65 for Stretching Control, with 20.0 participants listed per arm. A comparative entry conflicts with those arm values, and the record lists no analyses or confidence intervals. The safety record lists zero serious and zero other adverse events among 30 at risk in each group; deaths are not reported.

The study aimed to assess feasibility and gather preliminary information on fatigue, psychosocial outcomes, and quality of life. A BSI-18 change outcome is listed, but results for that and the broader clinical aims are not reported in the registry record. The record does not report the analysis population, missing-data approach, or detailed statistical plan.