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 Mindfulness Therapy for Individuals With Lung Cancer (NCT01565980), a randomized na study. The primary outcome is M.D. Anderson Symptom Inventory (MDASI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01565980 |
| Phase | NA |
| Condition | Lung Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Michigan State University |
| Results posted | Yes |
2. Clinical Question
Population
People with advanced non-small cell lung cancer undergoing non-curative treatment with radiation and/or chemotherapy. The registry describes an enrollment of 40 participants. Further eligibility details and participant characteristics are not reported in the registry record.
Intervention
A home-based mindfulness intervention delivered over 6 weeks, with weekly symptom assessment phone calls. The intervention incorporates meditation, breathing, and gentle yoga practices, according to the registry description.
Comparator
Six weeks of symptom assessment phone calls. The registry describes this as an attention control condition. Further details about the content or duration of the calls are not reported in the registry record.
Primary question
How did MDASI symptom severity and interference compare between the randomized groups at Time 2 (week 8), Time 3 (week 11), and in the overall average group comparison? Numerical group estimates and comparisons are not reported in the registry record.
The study purpose was to assess acceptability, feasibility, and symptom and health-related quality-of-life outcomes for a home-based mindfulness intervention during non-curative lung cancer treatment. The registry describes outcomes related to symptoms and health perceptions, physical function, and emotional function. It also identifies consent and retention, therapy expectancy, adherence, reasons for attrition, and quality assurance indicators as measures of acceptability and feasibility. Their numerical findings are not reported in the registry record.
This question is about the measured outcomes in the randomized groups, not whether the intervention should be used in clinical care. A group comparison can estimate how outcomes differed under the study conditions, but interpreting its precision requires the group estimates and uncertainty measures. Those numerical results are not reported in the registry record, so the direction, size, and precision of the MDASI comparison cannot be assessed from the information available.
3. Trial Design
The registry identifies this as a randomized, parallel-group study with single masking. It lists an enrollment of 40 participants and describes 20 participants assigned to the mindfulness intervention and 20 to symptom assessment. The identity of the people who were masked is not reported in the registry record. The phase is listed as NA.
The mindfulness group received 6 weeks of the home-based intervention and weekly symptom assessment phone calls. The symptom-assessment group received 6 weeks of symptom assessment phone calls. Both groups therefore had scheduled symptom-assessment contact, while the mindfulness group also received the intervention practices. Additional information about how randomization was generated, whether assignment was concealed, or how treatment adherence was handled is not reported in the registry record.
Outcome data were planned at baseline (Time 1), post-intervention at Time 2 (week 8), and four weeks after completion at Time 3 (week 11). The primary outcome description identifies adjusted means and standard errors at Times 2 and 3, followed by a summary of linear mixed effects for group comparisons. The numerical estimates and the details needed to reproduce the model are not reported in the registry record.
The listed study dates are a start in 2012-03 and primary completion in 2013-06; the status is COMPLETED. Michigan State University is listed as the sponsor. The registry record does not report the reason for choosing an enrollment of 40, a formal sample-size justification, or whether recruitment reached a prespecified target. It also does not report detailed eligibility criteria or the participants’ baseline demographic and clinical characteristics. Those omissions limit assessment of the population represented and of the study’s planning assumptions.
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: There were no participants excluded from the trial before group assignment. However, there were patients who dropped from the study before starting the intervention.
Overall Study
| Stage | Symptom Assessment | Mindfulness Intervention |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 16 | 16 |
| NOT COMPLETED | 4 | 4 |
Reasons for not completing this period:
| Reason | Symptom Assessment | Mindfulness Intervention |
|---|---|---|
| Death | 1 | 0 |
| Lost to Follow-up | 1 | 0 |
| health complications | 1 | 1 |
| stopped medical treatment | 1 | 0 |
| Withdrawal by Subject | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: Adjusted means of outcomes and their standard errors are reported for times 2 and 3. The summary of linear mixed effects for group comparisons are then presented.
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 | Attention Control | Mindfulness Intervention | Total |
|---|---|---|---|---|
| Participants analysed | 20 | 20 | 40 | |
| Age, Continuous | years | 67.9 (SD 9.5) | 64.5 (SD 9.25) | 66.2 (SD 9.4) |
| Sex: Female, Male: Female | Participants | 14 | 13 | 27 |
| Sex: Female, Male: Male | Participants | 6 | 7 | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 0 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 17 | 19 | 36 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 16 | 18 | 34 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Region of Enrollment: United States | participants | 20 | 20 | 40 |
6. Primary Endpoint
The registry lists the primary outcome as M.D. Anderson Symptom Inventory (MDASI), measured over Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons..
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is the M.D. Anderson Symptom Inventory (MDASI), a patient-reported measure of symptom severity and symptom interference. Its 13 core symptom items cover symptoms such as pain, fatigue, nausea, disturbed sleep, shortness of breath, and sadness. Participants rate each symptom at its worst on a 0-10 scale, where 0 means not present and 10 means as bad as you can imagine. The severity items are summed, with a stated range of 0 - 130.
The instrument also has 5 items about how much symptoms interfere with areas such as walking, work, general activity, mood, relationships, and enjoyment of life. These are rated on a 0-10 scale, where 0 means did not interfere and 10 means interfered completely. The interference items are summed, with a stated range of 0 - 50.
Patient-reported measures are used to capture symptoms and their impact as experienced by participants, including aspects that may not be represented by clinical observations alone. That is a general reason to use this type of endpoint; it does not establish that any particular score changed in this study. The registry names the MDASI as the primary outcome and specifies group comparisons at Time 2 (week 8), Time 3 (week 11), and an overall average. It does not report the numerical scores, adjusted means, or standard errors, so the observed symptom levels and group differences cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the broad design and the outcome being compared: participants were randomized to a home-based mindfulness intervention or symptom assessment, and MDASI outcomes were assessed at post-intervention and follow-up time points. It also states that adjusted means with standard errors were reported for Times 2 and 3 and that linear mixed-effects summaries were used for group comparisons. The actual estimates are not reported in the registry record.
Without the adjusted means, readers cannot tell whether the groups had similar or different symptom scores at either assessment, nor can they describe the direction or magnitude of a difference. Without the reported group-comparison estimates and their uncertainty, readers cannot assess how compatible the data are with a range of possible effects. The registry’s description of the analysis is not a substitute for its numerical result.
A standard error describes the uncertainty around an estimated mean under the statistical model; it is not itself a measure of participant-to-participant variation. This is a general statistical distinction. The registry identifies standard errors as the reported dispersion for adjusted means but does not give their values. Confidence intervals, exact test statistics, and p-values for the primary comparison are also not reported in the registry record. Consequently, the precision and statistical evidence for the group comparison cannot be evaluated.
The study included 40 participants, with 20 described in each group. That enrollment describes the trial size, not the precision of a particular endpoint estimate. Precision also depends on the observed outcome variability, missing observations, and the analysis model. Those numerical details are not available in the registry record. Nor does the record report a minimum clinically important difference for the MDASI, so clinical importance cannot be judged from an unreported estimate in any event.
The posted study purpose includes feasibility and acceptability as well as symptom and quality-of-life outcomes. Although the registry names consent, retention, expectancy, adherence, attrition reasons, and quality assurance indicators as measures, their results are not reported in the registry record. Thus it is not possible to conclude from this information whether the intervention was acceptable or feasible, or to compare its measured outcomes with the control condition. This is an account of what can and cannot be interpreted from the recorded results, not a conclusion about the intervention’s effect.
9. Statistical Methods Explained
The registry describes the trial as randomized and parallel-group. Randomization is intended, in general, to allocate participants by chance so that systematic differences between groups are less likely at the start of a study. It does not guarantee that the groups will be identical, especially in a small study. The record does not describe the randomization procedure, allocation concealment, or any checks on baseline balance, so those features cannot be assessed.
What does an adjusted mean represent?
In general, an adjusted mean is an estimate of the group’s average outcome from a statistical model, with adjustment for factors included in that model. The registry says adjusted means and standard errors were reported at Time 2 and Time 3. It does not identify the adjustment variables or provide the estimates. It is therefore not possible to say what covariates were controlled for, or to reconstruct the adjusted comparison.
A standard error expresses the estimated uncertainty in a model-based estimate. It is different from a standard deviation, which describes spread among individual observations. This distinction matters because an estimate can be accompanied by a small or large standard error depending on the amount of information and the model assumptions. The registry labels the dispersion for the adjusted means as standard error, but the numerical values are not reported in the registry record.
Why use a linear mixed-effects analysis?
In general, a linear mixed-effects model can account for repeated measurements from the same participant. Measurements from one person are often related to one another, and treating each measurement as independent can misrepresent uncertainty. A mixed-effects approach can model within-person dependence and compare outcomes across groups and times. The registry states that a linear mixed-effects summary was used for group comparisons. The model’s fixed and random effects, covariance structure, estimation method, and handling of incomplete repeated measurements are not reported in the registry record.
The MDASI is a continuous score, and the registry classifies the outcome as a mean of a continuous measure. A model for a continuous outcome estimates average levels or differences in averages. In general, its interpretation depends on the chosen scale, the model specification, and the assumptions about residual variation. The record identifies the measure’s item structure and score ranges but does not provide diagnostic checks or model assumptions.
How should an estimate and its uncertainty be read?
In general, a confidence interval gives a range of values compatible with the data and analysis under a stated confidence procedure. A narrow interval indicates greater precision than a wide interval, while neither interval width nor statistical significance alone establishes clinical importance. No confidence intervals are reported in the registry record for the primary outcome. The reported standard errors are also not numerically available, so the precision cannot be described.
A p-value, in general, measures how incompatible data are with a specified null model, subject to the analysis assumptions. It does not measure the probability that a treatment works, and it does not describe the size or clinical relevance of an effect. The primary outcome p-values and test statistics are not reported in the registry record. No conclusion about statistical significance can be drawn from the analysis description alone.
What do the planning illustrations mean?
Sample-size calculations based on an observed effect are planning illustrations, not observed power. In general, such an illustration asks what sample size might be needed to detect an effect of a specified size under chosen assumptions. The stated assumptions for the illustrations are a two-sided significance level of 0.05, equal allocation between groups, a normal approximation, and an effect set to a stated fraction of the observed effect. For non-time-to-event outcomes, the planned quantity is participants per arm for 80% power or another stated target when available. No numerical sample-size illustration values are reported in the registry record.
These assumptions do not establish how the original trial was designed. The registry does not report a sample-size justification or say that these illustrative calculations informed recruitment. An observed-effect-based planning calculation is also sensitive to uncertainty in the original effect estimate; it should not be presented as proof that the study had adequate power. The enrollment of 40 is a design fact, but the record does not provide enough information to judge the precision that enrollment achieved for the MDASI outcome.
Finally, interpretation of model results requires knowledge of the analyzed population and data completeness. The record does not state how many participants contributed MDASI observations at each time, whether analyses followed assignment regardless of adherence, or how missing outcomes were handled. Those choices can affect both estimates and uncertainty, particularly in a study with repeated assessments. They are not recoverable from the general statement that a mixed-effects summary was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures and 7 analyses. The primary outcome description includes symptom severity and interference and comparisons at Time 2 (week 8), Time 3 (week 11), and an overall average. Considering multiple outcomes, score components, or time points can create a multiplicity issue: in general, the chance of at least one apparently unusual result may increase when many comparisons are made. Whether and how this issue was addressed is not reported in the registry record.
The record does not report a prespecified hierarchy among the outcome measures, a multiplicity adjustment, or which analysis was designated as primary for each time point. It also does not report whether the analyses were prespecified or exploratory. The number of listed outcomes and analyses alone does not establish that a particular adjustment was required or omitted; it indicates that interpretation would benefit from a complete statistical analysis plan and results.
Missing-data methods and analysis populations are also not reported in the registry record. The planned assessment schedule includes baseline (Time 1), Time 2 (week 8), and Time 3 (week 11), but the number of observed outcomes at each time is unavailable. The record does not state whether missing values were imputed, whether mixed-model likelihood methods were used to accommodate incomplete repeated outcomes, or what assumptions were made about the reasons for missingness. It does not say whether the analysis included all randomized participants or was restricted to a subset.
These omissions matter because incomplete follow-up can affect the comparability of groups and the precision of estimates. In general, a statistical method does not remove the need to describe how much data are missing and why. The registry describes attrition reasons as a feasibility measure but does not report those findings. Accordingly, readers cannot evaluate missingness patterns, analysis-set definitions, or the robustness of the outcome findings.
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 |
|---|---|---|---|
| Symptom Assessment | 0 | 20 | 0.0% |
| Mindfulness Intervention | 0 | 20 | 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 |
|---|---|
| Symptom Assessment | 0 of 20 |
| Mindfulness Intervention | 0 of 20 |
The registry lists 20 participants at risk in each group for serious adverse events and 20 at risk in each group for other adverse events. It records 0 affected participants for serious adverse events in the symptom-assessment group and 0 in the mindfulness-intervention group. It also records 0 affected participants for other adverse events in each group. No serious adverse event terms are listed.
These figures describe the counts recorded in the registry. They do not, by themselves, establish that no adverse events of any kind occurred, that all events were collected, or that the groups had identical safety experience. The record does not provide event definitions, surveillance procedures, event severity, timing, or individual event details. The deaths field is null for both groups, which means deaths are not reported in the registry record; it should not be read as a reported count of zero.
In general, safety counts are interpreted alongside the size of the groups, length and completeness of follow-up, and methods for detecting and classifying events. Here, 20 participants are listed at risk per group, but further information about safety follow-up is not reported in the registry record. The figures therefore support only a narrow statement about the recorded affected-participant counts, not a broader comparison of safety or a conclusion about risk.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of a home-based mindfulness intervention with symptom-assessment phone calls among people with advanced non-small cell lung cancer receiving non-curative treatment. It identifies the MDASI as the primary outcome and specifies the assessments at Time 2 (week 8), Time 3 (week 11), and an overall average group comparison. These details define the study question and the planned measurement context.
The record does not report the numerical MDASI results. There are no adjusted means, standard errors, group-comparison estimates, confidence intervals, test statistics, or p-values in the information available for this analysis. As a result, it does not establish the observed direction, size, or precision of any symptom difference. The same limitation applies to the described health-related quality-of-life, acceptability, and feasibility outcomes: their numerical findings are not reported in the registry record.
This absence of numerical results is not evidence that the groups were the same, and it is not evidence that the intervention changed outcomes. It means that the outcome comparison cannot be evaluated from the record’s reported information. General statistical interpretation requires both an estimate and a measure of uncertainty; neither can be replaced by a study purpose or an analysis-method description.
The trial’s enrollment of 40 and its randomized group allocation describe the study design, not a demonstrated effect. Even if a planning illustration is based on an observed estimate, such an illustration is not observed power and does not supply missing trial results. Clinical importance would also require context about the magnitude of the score difference and its relevance to patients; a threshold for that interpretation is not reported in the registry record.
Accordingly, the justified reading is limited: the registry records a completed randomized parallel-group study and names its symptom endpoint and analysis approach, but it does not report enough numerical outcome information to characterize the primary comparison. No treatment recommendation follows from these registry entries.
13. Why This Trial Matters Statistically
This trial is statistically notable as a small randomized study focused on symptoms and health-related quality of life in a lung cancer population. The registry describes an intervention delivered at home and a comparator that also included weekly symptom assessment calls. That design makes the comparison one between the mindfulness program plus assessment calls and assessment calls alone, as described in the registry, rather than a comparison with no contact.
The study also identifies several types of outcomes: patient-reported symptom severity and interference, other health-related quality-of-life domains, and feasibility and acceptability indicators. In general, measuring these domains can help distinguish whether a study is assessing a clinical outcome, the practicality of delivering an intervention, or both. The registry states that all were within the study’s purpose, but the numerical findings for these measures are not reported in the registry record.
Repeated assessments at baseline, post-intervention, and follow-up create a setting where methods for correlated observations and incomplete data matter. The stated use of linear mixed-effects summaries signals an approach intended for group comparisons across repeated measurements. However, without the model details, participant counts at each time, and numerical estimates, the statistical adequacy and precision of those comparisons cannot be evaluated.
The record also illustrates why design details and results need to be read separately. Randomization and an enrollment of 40 describe how the study was structured; they do not establish an effect. Likewise, the listed adverse-event counts have a narrow interpretation without fuller safety follow-up details. For statistical readers, the central issue is not to infer a result from the study’s rationale or method, but to recognize which evidence the registry actually reports and which outcome quantities remain unavailable.
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 trial-specific details needed to interpret the outcome comparison are not reported in the registry record. The numerical MDASI results are absent, including adjusted means, standard errors, group-comparison estimates, and uncertainty measures. This prevents assessment of the direction, magnitude, and precision of the primary outcome comparison. Numerical findings for the other outcomes named in the study purpose are also not reported.
The record does not describe the masking procedures beyond identifying the study as single-masked. It does not identify who was masked or whether masking was maintained. Details of random sequence generation and allocation concealment are not reported. These omissions prevent a fuller assessment of the safeguards used in the randomized design.
Participant flow and data completeness are not reported in the information available. The planned measurements include baseline and follow-up, but the number assessed at each time, reasons for loss to follow-up, and analysis populations are not stated. Although attrition reasons were among the described feasibility measures, their results are not reported in the registry record. Missing-data handling and the assumptions used by the analysis are also not reported.
The intervention and control are described at a broad level, but further details about session content, delivery, adherence, and intervention fidelity are not available. The registry names therapy expectancy, adherence, and quality assurance indicators as measures without reporting their results. Baseline participant characteristics and fuller eligibility criteria are also not reported, limiting assessment of how well the enrolled group represents the population described.
Finally, the registry does not provide a sample-size justification, details of multiplicity handling, a protocol-level analysis plan, or the model specification. These limitations concern what can be evaluated from the registry record; they do not establish that the underlying study lacked these procedures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Mindfulness Therapy for Individuals With Lung Cancer — NCT01565980.
- Registry record last updated 2014-11-17; status last verified 2014-11.
- Results first posted 2014-11-17.
- 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
The registry record identifies a completed randomized, single-masked, parallel-group study sponsored by Michigan State University. Enrollment was 40, with the summary describing 20 participants assigned to a 6-week home-based mindfulness intervention and 20 to 6 weeks of symptom-assessment phone calls. The study concerned advanced non-small cell lung cancer during non-curative treatment.
The primary outcome was the MDASI, measuring symptom severity and interference. Assessments were scheduled at baseline (Time 1), Time 2 (week 8), and Time 3 (week 11); the stated group comparisons include an overall average. Adjusted means and standard errors and a linear mixed-effects summary are described, but numerical outcome estimates are not reported in the registry record.
The record lists 0 participants affected by serious adverse events and 0 affected by other adverse events in each group, with 20 at risk per group for each category. Deaths are not reported. Results for feasibility, acceptability, and other health-related quality-of-life outcomes are also not reported in the registry record.