Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0 (NCT03831100), a randomized na study. The primary outcome is Change in Body Image Scale Score From Baseline to 1-month Post-intervention.

2. Clinical Question

3. Trial Design

BRIGHT 2.0 is described in its official title as a single-site, parallel-group, randomized-controlled pilot trial. It compared BRIGHT with an active control among head and neck cancer survivors with body image-related distress. The registry reports randomized allocation and no masking. It also classifies the model as single-group, although the intervention and arm descriptions identify BRIGHT and active-control groups. The record does not explain this difference in classifications or describe the randomization procedure.

The intervention consisted of 5 weekly, 60-minute, tablet-based telehealth sessions with a licensed therapist. The active control was intended to match the intervention's frequency, intensity, and delivery method, using videos about head and neck cancer survivorship. The control description identifies electronic information about recovery; more detail on the video content is not reported in the registry record.

Enrollment was 54. The primary result lists 20 evaluable participants in BRIGHT and 24 in active control; these arm counts are not the same as the total enrollment. The primary analytic population was defined as eligible, randomized, evaluable patients. Patients who developed a recurrent or new primary cancer went off study per protocol and were not evaluable.

The study status is completed. The start date was 2020-07-13, and the primary completion date was 2022-02-22. The phase is listed as NA. The registry identifies the Medical University of South Carolina as sponsor. The protocol's planned sample-size justification, recruitment details, and any interim-analysis plan are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The efficacy analytic population consisted of all eligible, randomized, evaluable patients. Patients who developed a recurrent or new primary cancer went off study per protocol and were not evaluable.

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.

Population: The efficacy analysis population consisted of all eligible, randomized, evaluable patients. Patients who developed a recurrent or new primary cancer went off study per protocol and were not evaluable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Body Image Scale Score From Baseline to 1-month Post-intervention, measured over 1 month.

The primary endpoint was change in Body Image Scale score from baseline to one month after intervention. The Body Image Scale is a validated, 10-item patient-reported measure of the affective, cognitive, and emotional aspects of body image related to cancer or its treatment over the prior 7 days. Each response is scored from 0 to 3, and the total score ranges from 0-30. Higher scores indicate greater body image dissatisfaction.

A change score describes how a participant's measured score differs from baseline at the specified follow-up. Comparing mean change between randomized groups addresses whether the observed average change differed between BRIGHT and active control. A within-group change alone would not isolate the contrast between the interventions.

The scale is relevant to the trial's stated aim because the study concerns body image-related distress among head and neck cancer survivors. Using a validated patient-reported measure gives participants a structured way to report experiences that may not be captured by clinical observations alone. The registry identifies this measure and time point as primary; it does not report a threshold for interpreting a particular score change as clinically important.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the reported comparison estimate?

The outcome is a change in Body Image Scale score from baseline to one month after intervention. The arm-specific means describe average change within each group. The reported net mean difference is the between-group comparison from linear regression. These quantities answer related but distinct questions: within-group summaries describe what was observed in each arm, while the net contrast estimates how the arms differed under the reported model.

The analysis is described as linear regression, with mean difference (net) as its parameter. In general, linear regression models a continuous outcome or contrast as a function of specified predictors. The registry does not state which additional predictors, if any, were included, how model assumptions were checked, or how the analysis handled missing measurements. It is therefore not possible to infer those details from the name of the method alone.

How should the confidence interval be read?

The reported net mean difference is -2.1, with a 90% confidence interval from -5.0 to 0.9. In general, a confidence interval expresses uncertainty around an estimate under the statistical model and its assumptions. A 90% confidence procedure is designed to cover the target value in 90% of repeated applications under those assumptions; it does not mean that there is a 90% probability that this particular interval contains the true value.

For this result, the interval includes zero and values on either side of zero. Zero corresponds to no between-group difference in mean change. The interval therefore does not rule out no difference, and it also allows for differences in either direction. The width of an interval is one indication of precision: a wider interval represents greater uncertainty about the range of values compatible with the data and model. The posted interval alone does not identify why the uncertainty is present.

The arm-specific 90% confidence intervals are -5.4 to -1.5 for BRIGHT and -2.8 to 1.5 for active control. These intervals describe uncertainty around each arm's mean change, not uncertainty around the difference between arms. The inferential comparison is the separately reported regression estimate and its interval. Comparing the arm-specific intervals by eye is not a substitute for the model-based between-group analysis.

What does the p-value say?

The reported p-value is 0.25. In general, a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the analysis assumptions were correct. It is not the probability that the null hypothesis is true, nor is it a measure of the probability that the findings arose by chance. A p-value does not give the size or clinical importance of an effect. Here it should be read alongside the net estimate and its confidence interval; it does not remove the uncertainty expressed by the interval.

How does randomization relate to the comparison?

Randomized allocation is intended to make the comparison between groups informative by assigning participants to groups through a chance process. The registry reports randomized allocation, but does not report the sequence-generation method, allocation concealment, or implementation details. No masking was reported. These features affect how the study was conducted and interpreted, but their specific procedures cannot be inferred from the registry entry.

The population for the primary analysis was all eligible, randomized, evaluable patients. The record states that patients developing a recurrent or new primary cancer went off study per protocol and were not evaluable. This is not a statement that every randomized participant was included in the endpoint analysis. The handling of other missing data and the number of participants excluded for each reason are not reported in the registry record.

How should the planning illustration be understood?

The record describes planning illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the study had a particular probability of detecting an effect. The record also cautions that the study's own design is not represented by that calculation. The protocol's original sample-size assumptions and justification are not reported in the registry record.

In general, a power calculation asks what sample size would be needed to detect a prespecified effect under a chosen statistical model and assumptions. When the assumed effect is based on an observed estimate, the resulting planning figure is conditional on that estimate and can be sensitive to its uncertainty. It should not be treated as a new finding about participants in this trial. No additional sample-size value is stated in the statistical result.

What is not specified?

The registry lists 14 outcome measures and 14 analyses, and 13 secondary outcomes are posted. The primary endpoint is identified, but the record does not describe a multiplicity adjustment or say how the primary and secondary analyses were prioritized beyond that designation. General statistical practice recognizes that examining many outcomes can increase the chance of at least one apparently unusual result. Whether and how that issue was addressed in this trial is not reported in the registry record.

The posted result is a mean-based comparison. The record does not report diagnostics for the regression model, a distributional assessment, an alternative analysis, or a sensitivity analysis. Those details could affect how readers evaluate the robustness of the estimate, but should not be guessed. The stated findings are the reported means, confidence intervals, p-value, and analytic population description.

10. Analyses Reported by the Sponsor

The registry reports a linear-regression analysis with a net mean difference of -2.1, a 90% confidence interval from -5.0 to 0.9, and p = 0.25. This is the reported inferential comparison between BRIGHT and active control. The arm means and their confidence intervals are descriptive summaries of change within each group; they do not replace the regression estimate.

No separate recalculated between-group estimate is reported in the registry record. Reconstructing a regression result from the posted arm summaries would not reproduce any model adjustments that may have been used, and the registry does not specify those details. The record does not flag a discrepancy between the reported analysis and another estimate. The sponsor's reported analysis is therefore the appropriate result to cite as the trial's inferential comparison, while recognizing the uncertainty in its confidence interval and p-value.

The posted comparison is not evidence of a confirmed treatment effect. Its estimate is negative, but the interval extends across zero and the p-value is 0.25. The record does not report a prespecified clinical-importance threshold or enough detail to independently assess all model choices. The sponsor result should be read as a preliminary comparison in a pilot trial, not as a definitive statement about the relative clinical impact of the interventions.

11. Multiplicity, Missing Data and Analysis Populations

The registry identifies one primary endpoint: change in Body Image Scale score from baseline to one month after intervention. It also reports 14 outcome measures and 14 analyses, with 13 secondary outcomes posted. The listed secondary outcomes include body image, shame and stigma, depression, and anxiety measures at specified follow-up times. The record does not provide the complete details of every analysis in the registry entry summarized by these counts.

When several outcomes or time points are examined, the chance of observing at least one result that appears unusual can increase. Statistical approaches to multiplicity may adjust thresholds or otherwise account for the set of analyses. Whether an adjustment was planned or used is not reported in the registry record. The record also does not give a prespecified hierarchy for interpreting secondary outcomes. For that reason, secondary findings should not be treated as though each were the sole confirmatory test.

The registry defines the primary efficacy population as eligible, randomized, evaluable patients. It states that patients who developed a recurrent or new primary cancer went off study per protocol and were not evaluable. The primary outcome lists 20 evaluable BRIGHT participants and 24 evaluable active-control participants. Total enrollment was 54; the registry does not explain the full flow from enrollment to the endpoint counts or list all reasons participants may not have been evaluable.

Details about missing observations, imputation, withdrawals, adherence, and sensitivity analyses are not reported in the registry record. It is therefore not possible to determine from this entry whether missing measurements could have affected the comparison or how robust the result is to alternative missing-data assumptions. The analysis population description should be kept distinct from an assumption that every randomized participant contributed a primary endpoint measurement.

The protocol's sample-size justification and any interim-analysis plan are not reported in the registry record. The planning illustration described in the record is based on the observed effect and is not the trial's own design justification. It is not observed power and does not resolve the uncertainty in the primary estimate.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

For serious adverse events, the registry reports 0 affected participants among 20 at risk in BRIGHT and 0 among 24 at risk in active control. It also reports 0 deaths in each arm. For other adverse events, it reports 0 affected participants among 20 at risk in BRIGHT and 0 among 24 at risk in active control. No top serious adverse-event terms are listed.

These figures describe the adverse-event information posted for the listed at-risk groups. A recorded zero means that no affected participants were reported in these categories in the registry results; it does not establish that no symptoms, events, or harms occurred outside the categories or reporting procedures represented by those entries. The record does not give event definitions, collection procedures, severity details for other events, or a fuller account of follow-up for safety.

The safety counts should also be kept distinct from the total enrollment of 54 and from the primary endpoint's analytic population. The registry lists the at-risk groups separately for adverse events. These figures do not quantify comparative risk precisely, and they should not be taken as proof that either intervention is free of risk. They are a concise description of the adverse-event counts recorded for this trial.

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

The primary result estimates the difference between BRIGHT and active control in mean change in body image score at one month. The posted net mean difference is -2.1, with a 90% confidence interval from -5.0 to 0.9 and p = 0.25. The estimate points toward a greater decrease in score in BRIGHT, but the interval includes zero and also extends in the opposite direction. The result therefore remains uncertain about the size and direction of the between-group difference.

The within-arm summaries show a mean change of -3.5 in BRIGHT and -0.7 in active control. These values describe observed average changes in each group; they do not by themselves establish that the groups differed. The regression comparison is the relevant posted analysis for the between-group question. Higher Body Image Scale scores indicate greater dissatisfaction, so the direction of a score change is interpretable, but the registry does not report what magnitude of change participants would consider important.

The result does not establish that BRIGHT is effective or ineffective, nor does it establish equivalence between the interventions. An interval that includes zero is not proof of no difference. It indicates that the available estimate is compatible with no difference as well as with differences in either direction under the reported analysis. The p-value is also not a measure of clinical importance.

The evidence is specific to this pilot comparison, its eligible and evaluable population, and the one-month primary follow-up. The record lists several other outcomes and follow-up times, but does not provide enough information in this result to draw conclusions about longer-term outcomes, psychological or social wellbeing generally, or the proposed role of coping behavior. Such conclusions would require their own posted results and analysis details.

The registry does not report the original sample-size justification, missing-data methods, multiplicity approach, or a clinical-importance threshold. These omissions limit how fully the precision and interpretation can be assessed. The primary result is best read as a preliminary, uncertain estimate rather than a definitive comparison of the interventions.

14. Why This Trial Matters Statistically

This trial is statistically informative because it distinguishes a within-arm change from a randomized between-arm comparison. The average score decreased in both groups, but the question of interest is whether the change differed between them. The reported regression estimate addresses that contrast. Keeping the two kinds of summaries separate prevents changes over time within one group from being mistaken for evidence that the intervention outperformed its comparator.

The active control was intended to match the intervention's frequency, intensity, and delivery method. This design makes the comparison about BRIGHT relative to an active survivorship-information program, rather than simply relative to no contact. The registry describes randomized allocation but gives no detail on how it was implemented, and reports no masking. Those design features matter when considering what the comparison can establish.

The interval is as important as the point estimate. The net estimate is -2.1, while the 90% confidence interval ranges from -5.0 to 0.9. The interval covers zero and values on both sides, making clear that the direction and magnitude are not estimated precisely enough to settle the between-group question. A point estimate alone would hide that uncertainty.

The record also illustrates why a pilot result should be read alongside the analysis population and reporting detail. The primary endpoint includes 20 BRIGHT participants and 24 active-control participants, while total enrollment is 54. The registry defines who was considered evaluable, but does not fully explain the flow into the analysis counts or the handling of missing data. Those details affect the interpretation of precision and generalizability.

Finally, the trial includes multiple outcomes and follow-up times, but does not report a multiplicity plan in the registry record. Identifying the primary endpoint helps orient interpretation; the status of secondary analyses remains less clear. Together, these features make the result useful as a preliminary estimate while underscoring why statistical uncertainty, design, and reporting completeness should be considered alongside the estimate.

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.

The primary comparison is based on the evaluable endpoint groups listed in the registry, rather than all 54 enrolled participants. The registry defines the efficacy population and notes that patients developing a recurrent or new primary cancer went off study per protocol. It does not provide a complete participant flow or explain all differences between enrollment and the endpoint counts. Other causes of non-evaluability or missing measurement are not reported in the registry record.

The record does not describe the randomization sequence, allocation concealment, or how the allocation process was implemented. It reports no masking. The intervention required sessions with a licensed therapist, while the active control consisted of videos; the registry does not report whether outcome assessors or analysts were masked. These details cannot be inferred, and their absence from the record limits assessment of potential sources of bias.

The primary result is reported as linear regression, but the model specification, covariate adjustment, diagnostic checks, and missing-data methods are not reported in the registry record. The record also does not state whether multiplicity was addressed across the 14 outcome measures and analyses. These omissions make it difficult to assess the robustness of the reported inference or to compare the primary result with secondary findings.

The registry does not report a protocol-based sample-size justification or a clinically important difference for the Body Image Scale. Consequently, the result's precision cannot be evaluated against a stated design target, and the score change cannot be classified using a trial-specific clinical threshold. The record describes this as a pilot trial, and the primary follow-up is one month after intervention; longer-term conclusions are not established by this endpoint.

The control description available in the record is incomplete, and the record does not give detailed implementation or adherence results. The study is identified as single-site, which may limit how broadly its findings apply to other settings. The registry's single-group model classification also sits alongside randomized two-arm descriptions, without an explanation of the discrepancy in terminology.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) 2.0 — NCT03831100.
• Registry record last updated 2023-08-09; status last verified 2023-07.
• Results first posted 2023-08-09.
• 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

BRIGHT 2.0 was a completed, single-site randomized pilot trial comparing a tablet-based therapist-delivered BRIGHT intervention with an active control consisting of survivorship videos. It enrolled 54 head and neck cancer survivors with body image-related distress. The primary endpoint was change in Body Image Scale score from baseline to one month after intervention.

The posted mean changes were -3.5 for BRIGHT and -0.7 for active control. The reported linear-regression net mean difference was -2.1, with a 90% confidence interval from -5.0 to 0.9 and p = 0.25. The interval includes zero, leaving uncertainty about the between-group difference. The primary endpoint counts were 20 and 24 evaluable participants, respectively.

The record lists 14 outcome measures and analyses and 13 posted secondary outcomes. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths in each listed at-risk group. Details on the original sample-size justification, multiplicity, missing-data handling, and full analysis model are not reported in the registry record.