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 Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers (NCT03538587), a randomized na study. The primary outcome is Percentage of Eligible Dyads (Parent-child) Who Enroll During a Two-year Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03538587 |
| Phase | NA |
| Condition | Glioblastomas, Sarcoma, Astrocytoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | 2 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Children and young adults ages 5–24 with a high-grade or high-risk cancer, together with a caregiver who agreed to participate. Participants needed internet access and had to speak English.
Intervention
The enhanced mindfulness intervention included an in-person session, at-home assignments, and two booster sessions. The registry describes separate child and parent sessions followed by time together during the in-person training.
Comparator
The control group received psychoeducation: a brief meeting with a research team member to assess parent and child coping, along with educational material about coping with cancer.
Primary question
What percentage of eligible parent-child dyads enrolled during a two-year period, and how did the recorded enrollment percentages compare between the two randomized groups?
The trial, NCT03538587, was designed as a pilot randomized controlled study of an enhanced mindfulness intervention for children and young adults with high-grade or high-risk cancer and their caregivers. The registry states that the broader objective was to learn whether mindfulness was feasible and acceptable for this population and caregivers. The posted primary endpoint addresses one part of feasibility: enrollment among dyads identified as eligible.
The outcome is expressed at the dyad level, with each dyad consisting of one child and one parent. The registry reports that two dyads were analyzed in the enhanced mindfulness group and three in the psychoeducation group. The primary results list 100.0% for each group. These are recruitment results, not measurements of symptom change, quality of life, or the effects of mindfulness practice. The registry record does not report a comparative estimate with uncertainty or a formal test of a difference between groups.
3. Trial Design
This was a randomized, parallel-group pilot trial with no masking. The registry lists the phase as not applicable. The planned comparison was between an enhanced mindfulness intervention and a psychoeducation control. The intervention description includes an in-person session, a series of at-home assignments, and two booster sessions. The control description specifies a brief coping assessment with a research team member and educational material about coping with cancer.
The registry’s general study description says that participants would complete questionnaires about feelings, physical well-being, quality of life, and mindfulness, and that researchers would review children’s medical records. It also describes random assignment to a mindfulness group or a standard-care group. The arm descriptions identify the control as a psychoeducation group. The registry record does not report further detail about how randomization was generated or implemented, or whether allocation was concealed.
The recorded enrollment was 10. For the primary endpoint, the registry identifies two analyzed dyads in the enhanced mindfulness group and three in the psychoeducation group. Those outcome counts are dyad counts, whereas the overall enrollment is recorded as a participant count; the record does not explain the relationship between these counts. The trial status is completed. The listed start date is 2019-01-29, and the primary completion date is 2022-09-13.
The primary endpoint concerns the percentage of eligible dyads who enrolled during a two-year period. Although the registry describes the study as a pilot randomized controlled trial, the record does not report a sample-size justification, a detailed statistical analysis plan, or planned interim analyses. The registry also does not report the number of eligible dyads from which the enrolled dyads were drawn. These omissions limit interpretation of how recruitment performance was defined and how precisely it can be estimated.
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 | Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group | Arm 2 Control Group - Psychoeducation Group |
|---|---|---|
| STARTED | 4 | 6 |
| Child Participants | 2 | 3 |
| Parent Participants | 2 | 3 |
| COMPLETED | 2 | 2 |
| NOT COMPLETED | 2 | 4 |
Analysis population for the primary outcome, as defined in the registry: Each dyad = 1 child, 1 parent. Two dyads were analyzed in group 1 (i.e., 2 children, 2 parents), and three dyads were analyzed in group 2 (i.e., 3 children, 3 parents).
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 | Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group | Arm 2 Control Group - Psychoeducation Group | Total |
|---|---|---|---|---|
| Participants analysed | 4 | 6 | 10 | |
| Age, Categorical: <=18 years | Participants | 2 | 3 | 5 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 3 | 5 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous: Child participants | years | 11.0 (SD 2.82) | 13.33 (SD 4.73) | 12.16 (SD 3.77) |
| Age, Continuous: Parent participants | years | 44.0 (SD 5.66) | 42.0 (SD 6.56) | 43.0 (SD 6.11) |
| Sex: Female, Male: Female | Participants | 4 | 5 | 9 |
| Sex: Female, Male: Male | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 2 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 4 | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 4 | 5 | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 4 | 6 | 10 |
| School Setting for Child Participants: Public | Participants | 1 | 3 | 4 |
| School Setting for Child Participants: Home School | Participants | 1 | 0 | 1 |
| Current School Grade Level for Child Participants: Grade 12 | Participants | 0 | 1 | 1 |
| Current School Grade Level for Child Participants: Grade 10 | Participants | 0 | 1 | 1 |
| Current School Grade Level for Child Participants: Grade 7 | Participants | 1 | 0 | 1 |
| Current School Grade Level for Child Participants: Grade 4 | Participants | 1 | 0 | 1 |
| Current School Grade Level for Child Participants: Grade 3 | Participants | 0 | 1 | 1 |
| Occupation Status for Parent Participants: Working | Participants | 1 | 1 | 2 |
| Occupation Status for Parent Participants: Not working | Participants | 0 | 1 | 1 |
| Occupation Status for Parent Participants: On leave | Participants | 1 | 0 | 1 |
| Occupation Status for Parent Participants: Disability | Participants | 0 | 1 | 1 |
| Marital Status: Single | Participants | 0 | 1 | 1 |
| Marital Status: Married | Participants | 2 | 2 | 4 |
| Number of Parent Participants Working (Hours/Weeks): 40 Hours/Week | Participants | 0 | 1 | 1 |
| Number of Parent Participants Working (Hours/Weeks): 37 Hours/Week | Participants | 1 | 0 | 1 |
| Number of Parent Participants Working (Hours/Weeks): Not Working | Participants | 1 | 2 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Eligible Dyads (Parent-child) Who Enroll During a Two-year Period, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of dyads |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the percentage of eligible parent-child dyads who enrolled during a two-year period. The registry defines each dyad as one child and one parent, and defines the percentage as the number of dyads enrolled divided by the number of dyads found eligible. This is a recruitment or feasibility measure: it describes the proportion of eligible families who entered the study, rather than a clinical outcome after assignment.
The posted result is 100.0% for the enhanced mindfulness group and 100.0% for the psychoeducation group. The registry identifies two analyzed dyads in the first group and three in the second. The number of eligible dyads in each group, the underlying numerator and denominator details, and uncertainty intervals are not reported in the registry record. Therefore, the percentages alone do not show how stable the estimates might be in a broader group of eligible families.
Recruitment is relevant in a pilot study because it indicates whether eligible dyads entered the trial. It is distinct from acceptability, retention, adherence, or clinical benefit. The registry’s stated objective includes feasibility and acceptability, but the primary endpoint specifically measures enrollment. The record does not report a statistical comparison of the two percentages or additional endpoint results that would establish other aspects of feasibility or acceptability.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint results are 100.0% in the enhanced mindfulness group and 100.0% in the psychoeducation group. In the registry definition, the endpoint is the proportion of eligible parent-child dyads who enrolled during a two-year period. The posted percentages therefore describe recruitment, not response to mindfulness or change in health, well-being, or quality of life.
The outcome population description reports two analyzed dyads in the enhanced mindfulness group and three in the psychoeducation group. These counts are limited, so the percentages should be read as observations from a pilot trial rather than as precise estimates of recruitment performance in a larger population. The registry does not report the eligible-dyad denominators for either group or confidence intervals. Without those details, the uncertainty around the percentages cannot be assessed from the record.
Both groups have the same posted percentage. The registry does not provide a formal between-group test, an effect estimate for the difference, or an uncertainty interval for a comparison. A matching pair of displayed percentages should not be taken as proof that the groups are equivalent. It also does not establish that enrollment would be the same in other settings or among all eligible families. The randomized design defines the intended comparison, but the posted endpoint and its small analyzed dyad counts do not support a broad conclusion about comparative intervention effects.
The overall recorded enrollment is 10 participants, while the primary outcome description identifies five analyzed dyads across the two arms. The registry record does not explain how the overall participant enrollment corresponds to the dyads included in this endpoint. These are different units, and they should not be treated as interchangeable. The result should be interpreted using the endpoint’s dyad-level description and its arm-specific analyzed dyad counts.
The trial’s stated broader aim included learning whether the intervention was feasible and acceptable. The enrollment percentage is relevant to feasibility, but it does not alone capture acceptability, completion of sessions, adherence to at-home assignments, or caregiver and participant experience. Although the registry lists five outcome measures, no secondary outcome results are reported in the registry record. Thus the posted primary endpoint gives a narrow account of recruitment, while other dimensions of the pilot’s objectives remain unreported.
Overall, the registry records complete enrollment percentages in both arms among the analyzed dyads, with the underlying eligible denominators and statistical uncertainty not reported. The result is descriptive. No conclusion about clinical efficacy or a difference between mindfulness and psychoeducation follows from this recruitment endpoint.
9. Statistical Methods Explained
The primary outcome is a percentage with dyads as its unit. Each dyad consists of one child and one parent. The registry defines the percentage as the number of enrolled dyads divided by the number of dyads found eligible during the recruitment period. This makes the endpoint a measure of enrollment relative to eligibility, rather than a count of individual participants or a clinical response measure.
What does a percentage endpoint convey?
In general, a percentage expresses a numerator relative to a denominator. The denominator is essential for interpretation: the same percentage may be based on different amounts of information, and estimates based on few observations can be less stable. For this trial, the record reports the percentage in each arm and the number of analyzed dyads, but it does not report the number of eligible dyads in each arm. The underlying eligible denominators are therefore not available for evaluating how precisely the recruitment percentages represent the eligible population.
The posted values are 100.0% in each group. The registry describes two analyzed dyads in the enhanced mindfulness group and three in the psychoeducation group. No confidence interval is reported. In general, a confidence interval gives a range of values compatible with the data under a specified statistical method and reflects sampling uncertainty. Without an interval or enough reported denominator information to reconstruct one, the precision of these percentages cannot be assessed from the registry record. No additional calculation is needed to see that the reported values are descriptive rather than a reported inferential comparison.
What does randomization contribute?
In general, random assignment is used to create groups whose differences at the start of a study are not systematically determined by participant or investigator choice. It supports a fair comparison of assigned groups when the trial’s conduct and analysis preserve the randomized comparison. Here, the registry lists randomized allocation and a parallel design, with enhanced mindfulness and psychoeducation arms. It does not report the sequence-generation method, allocation concealment, or a detailed analysis plan. Randomization alone does not supply missing outcome denominators, uncertainty intervals, or evidence about outcomes that were not posted.
The trial is described as a pilot randomized controlled trial. A pilot can provide descriptive evidence about study processes, including recruitment, but the record does not report a sample-size justification or a planned precision target for the enrollment endpoint. The overall enrollment is 10, and the primary outcome description lists two and three analyzed dyads in the respective groups. These limited counts make it especially important not to treat the displayed percentages as highly precise estimates.
Why is there no reported significance test?
The registry record lists no statistical analyses. It reports the primary endpoint values but does not report a hypothesis test, p-value, effect estimate for the arm contrast, or confidence interval. A significance test, in general, evaluates how compatible data are with a specified null hypothesis under assumptions of a statistical model. Without a posted test and the information needed to interpret one, no statistical significance claim can be made. The equal displayed percentages are not a formal equivalence result: equivalence requires a defined margin and an analysis designed to assess whether differences fall within that margin. Neither is reported in the registry record.
For a comparison of enrollment percentages, the analysis would need to respect the dyad as the unit and account for the actual eligible and enrolled counts. This is a general explanation of the information needed, not a description of an analysis reported for this trial. The registry does not provide the eligible denominators, a comparison method, or an adjusted or unadjusted contrast. There is consequently no basis in the record for reconstructing a formal comparison or its uncertainty.
How should the study structure be read?
The parallel design means participants were assigned to one of the two study groups for the recorded comparison. The registry lists no masking. The intervention is behavioral, as is the psychoeducation control. The arm descriptions identify different study activities, but the primary endpoint is enrollment rather than an outcome measured after those activities. A result on enrollment therefore cannot answer whether either group changed participants’ symptoms, quality of life, or mindfulness.
In general, over-dispersion matters when count data vary more than a chosen statistical model expects, because estimates of uncertainty based on a simpler variance assumption may be too narrow. That issue is not a reported feature of this endpoint: the primary measure is a percentage of eligible dyads, and the registry does not report a count model or a variance model. No claim about over-dispersion or a model-based analysis is warranted for this trial.
Interpretation is further constrained because the registry gives an overall enrollment count of 10 participants but reports the primary outcome in dyads, with two and three dyads analyzed by arm. It does not explain the relationship between these counts. Maintaining the distinction between participant-level and dyad-level quantities avoids treating them as if they were the same denominator. The posted endpoint is best read as a descriptive recruitment result for the dyads identified in the outcome record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, but it reports only the primary endpoint results in the available record. No secondary outcome results are reported in the registry record. The stated broader study objectives include feasibility and acceptability, while the primary endpoint captures enrollment. Without posted secondary results, the record does not show whether questionnaires, acceptability measures, or other outcomes were analyzed or what those results were.
Multiplicity refers, in general, to the risk of misleading findings when many outcomes or statistical tests are considered. A study may address this through prespecified outcome hierarchies or other procedures, but the statistical plan and any multiplicity approach are not reported in the registry record. Since no statistical analyses are listed, there are no posted tests across outcomes to interpret or adjust.
Missing-data methods and analysis populations are also not described. The record does not report how missing questionnaires or incomplete follow-up were handled, whether every randomized dyad was included in each outcome analysis, or reasons for any exclusions. The primary endpoint description gives the dyads analyzed by arm, but it does not provide a full participant flow or explain the relation between the overall enrollment of 10 and the five analyzed dyads.
These gaps mean the posted endpoint can be read descriptively, but the completeness of the outcome data and the basis for inclusion in analyses cannot be evaluated from the registry record. No missing-data assumption, intention-to-treat approach, or per-protocol approach should be inferred.
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 |
|---|---|---|---|
| Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group | 0 | 4 | 0.0% |
| Arm 2 Control Group - Psychoeducation Group | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group | 0 of 4 |
| Arm 2 Control Group - Psychoeducation Group | 0 of 6 |
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 |
|---|---|
| Arm 1 Enhanced Mindfulness Intervention (EMI) - Immediate Group | 0 of 4 |
| Arm 2 Control Group - Psychoeducation Group | 0 of 6 |
The safety record lists zero serious adverse events and zero other adverse events in both study groups, and it records zero deaths in both groups. The safety groups report four participants at risk in the enhanced mindfulness group and six at risk in the psychoeducation group. No serious adverse-event terms are listed.
These figures are counts of events or affected participants as recorded in the safety results; they are not estimates of comparative risk. The registry does not report a statistical comparison, confidence intervals, event-specific follow-up time, or additional detail about safety monitoring. The at-risk counts also differ from the dyad counts reported for the primary endpoint, and the record does not explain the relationship between those populations. The two types of counts should therefore be kept distinct.
A record of zero reported events means that no events are listed for these categories in the posted results. In general, observing no events does not establish that an event cannot occur, particularly when the number of participants represented is limited. These safety counts do not establish comparative safety between groups or address outcomes not included in the registry’s safety record.
12. What the Result Does, and Does Not, Mean
The primary result is a recruitment measure. The registry reports that 100.0% of eligible dyads enrolled in each randomized group, with two analyzed dyads in the enhanced mindfulness group and three in the psychoeducation group. This describes the recorded enrollment outcome for the trial; it is not evidence about clinical improvement, symptom reduction, quality of life, or the effect of mindfulness practice.
The values do not establish that recruitment would be equally successful in another setting or population. The eligible-dyad denominators and confidence intervals are not reported in the registry record, so the stability and precision of the percentages cannot be determined. The displayed equality is not proof of equivalence, and no formal between-group comparison is reported.
The registry identifies the study as a pilot and states an objective of assessing feasibility and acceptability. Enrollment is one relevant feasibility dimension, but it does not by itself tell whether participants found the program acceptable, completed the sessions, followed at-home assignments, or experienced changes in the questionnaires described in the study summary. Although five outcome measures are listed, secondary results are not reported in the registry record.
Nor does the endpoint establish that the intervention is effective or ineffective. It was defined as the proportion of eligible dyads who enrolled, rather than a clinical endpoint comparing outcomes after treatment. The appropriate scope of interpretation is therefore narrow: the posted results record the same enrollment percentage in both arms among the analyzed dyads, while leaving precision, broader feasibility, acceptability, and clinical outcomes unresolved.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a pilot feasibility outcome and a clinical efficacy outcome. Its primary endpoint measures recruitment among eligible parent-child dyads. Such a measure can describe whether eligible families entered a study, but it does not answer whether an intervention changes health or well-being. Keeping the endpoint’s purpose clear prevents a recruitment result from being interpreted as a treatment effect.
The record also illustrates why denominators matter. A percentage is interpretable only in context, and the number of eligible dyads is not reported for either arm. The outcome description gives the analyzed dyad counts, while overall enrollment is recorded in participants. The registry does not explain the relationship between these units. Readers therefore need to distinguish the dyad-level endpoint from the participant-level enrollment figure rather than treating them as equivalent.
Finally, the record demonstrates the limits of descriptive results without uncertainty estimates or an analysis plan. Both groups have a posted enrollment percentage of 100.0%, but no confidence interval or formal comparison is reported. The result is a useful account of what was recorded in this pilot, but it does not quantify how precisely the result generalizes or establish equivalence between the groups. Those distinctions are central to interpreting small randomized studies responsibly.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint has limited interpretability because the registry does not report the number of eligible dyads in either arm. It provides the enrollment percentages and the analyzed dyad counts, but not confidence intervals or a formal comparison. The precision of the recruitment estimates cannot therefore be assessed from the posted information.
The study’s overall enrollment is 10 participants, while the outcome description identifies two analyzed dyads in one group and three in the other. The record does not explain the relationship between participant enrollment and the dyad-level outcome population. It also does not report participant flow, exclusions, or reasons that some enrolled participants may not appear in the outcome counts.
The registry lists five outcome measures, but secondary results are not reported. Although the study objective includes acceptability and feasibility, the posted primary result concerns enrollment. Details on acceptability, adherence, completion, and questionnaire outcomes are not reported in the registry record. The statistical analysis plan, sample-size justification, missing-data methods, and multiplicity approach are also not reported. These limits make the posted evidence descriptive and narrow in scope.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers — NCT03538587.
- Registry record last updated 2023-08-01; status last verified 2023-07.
- Results first posted 2023-08-01.
- 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
NCT03538587 is a completed, randomized, parallel-group pilot trial with no masking and phase listed as not applicable. It compared an enhanced mindfulness intervention with psychoeducation among children and young adults with high-grade or high-risk cancer and their caregivers. Recorded enrollment was 10 participants.
The primary endpoint was the percentage of eligible parent-child dyads who enrolled during a two-year period. The posted result was 100.0% in each group; the outcome description reports two analyzed dyads in the intervention group and three in the control group. The eligible denominators and uncertainty intervals are not reported in the registry record. No statistical analyses or secondary outcome results are listed.
The safety results report zero serious adverse events, zero other adverse events, and zero deaths in both groups. The trial started on 2019-01-29 and had a primary completion date of 2022-09-13. The posted primary result describes recruitment and does not establish clinical efficacy or a formal difference between groups.