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 Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer (NCT02836769), a na na study. The primary outcome is Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02836769 |
| Phase | NA |
| Condition | Head and Neck Neoplasms |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sunnybrook Health Sciences Centre |
| Results posted | Yes |
2. Clinical Question
Population
Survivors of head and neck cancer were the intended population for the Rehabilitation Consult program. The registry record identifies head and neck neoplasms as the condition and describes goals related to rehabilitation needs, individualized goals, action plans, and support. Enrollment was 35. Eligibility criteria and further participant characteristics are not reported in the registry record.
Intervention
The intervention was Rehabilitation Consult, a behavioral program. Its stated goals were to increase knowledge of rehabilitation needs and resources, establish individualized rehabilitation goals and action plans, and support survivors in implementing and evaluating those plans. Further details about the program’s components, duration, or delivery are not reported in the registry record.
Comparator
There was no registered comparison group. The pilot evaluation used a single-group pre-post design, with allocation listed as NA and masking listed as none. Results therefore cannot be interpreted as a randomized comparison of Rehabilitation Consult with another intervention or with usual care.
Primary question
The primary outcome was change in the Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N), a self-report measure of cancer-specific quality of life. The registry record specifies assessment at 1 week post-intervention and 1-2 months post intervention. It does not report the numerical scores or change estimates. The central statistical question is therefore whether the record contains evidence about change in quality of life; the posted registry information describes how change was to be measured but does not provide the results needed to quantify it.
3. Trial Design
This was a completed pilot evaluation registered as a single-group pre-post study of Rehabilitation Consult (RC). The registry record lists enrollment of 35 and the condition as head and neck neoplasms. The intervention is classified as behavioral. Allocation is listed as NA, masking as none, and the study model as single group. The record lists the phase as NA.
The registered dates are 2016-01 for study start and 2017-12 for primary completion. The sponsor was Sunnybrook Health Sciences Centre. The registry summary says the broader project involved both intervention development and pilot evaluation, while this registration describes only the pilot evaluation phase. The record does not describe the development phase as part of the registered evaluation.
A pre-post design measures participants in relation to an intervention without a separate control group. In general, such a design can describe within-group change over time, but it cannot by itself separate change associated with the intervention from other explanations, such as changes over time or other events affecting participants. There is no like-for-like control comparison in this study.
The primary outcome was change in FACT - H&N, with timeframes listed as 1 week post-intervention and 1-2 months post intervention. The registry record also lists change in goal performance, satisfaction, and self-efficacy as a secondary outcome. The schedule for baseline measurement, other assessment details, and the operational definitions for the secondary outcome are not reported in the registry record. Numerical outcome results and analysis methods are also 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
| Stage | Rehabilitation Consult (RC) |
|---|---|
| STARTED | 35 |
| Received Intervention | 30 |
| Completed Post-test Assessment | 21 |
| COMPLETED | 20 |
| NOT COMPLETED | 15 |
Reasons for not completing this period:
| Reason | Rehabilitation Consult (RC) |
|---|---|
| Lost to Follow-up | 10 |
| Medical withdrawal | 2 |
| Withdrawal by Subject | 3 |
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 | Rehabilitation Consult (RC) |
|---|---|---|
| Participants analysed | 35 | |
| Age, Continuous | years | 59.8 (SD 13) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 28 |
| Race and Ethnicity Not Collected | Participants | — |
| Weeks post-treatment | weeks | 38.2 (SD 22) |
| Had rehab goals | Participants | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N), measured over A) 1 week post-intervention, B) 1-2 months post intervention.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change in the Functional Assessment of Cancer Therapy - Head and Neck (FACT - H&N). The registry describes it as a cancer-specific self-report measure of quality of life, with higher scores indicating higher self-reported quality of life. Its stated possible range is 0 to 148. The endpoint description says that changes in the overall score and subsets would be evaluated for evidence of impact of the intervention.
The registry lists assessment timeframes of 1 week post-intervention and 1-2 months post intervention. It specifies the outcome parameter as a mean and its dispersion as a standard deviation. These details indicate the type of summary intended, but the registry record does not report actual scores, standard deviations, or changes at either timeframe. It also does not report a confidence interval or a statistical test for the primary outcome.
As a general measurement principle, a change score can describe how a participant’s measured score differs across assessment times. A mean change summarizes the average difference in the group, while a standard deviation describes how much individual scores vary around that average. Without the observed values and their uncertainty, the direction, size, and precision of any change in FACT - H&N cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically relevant measurement target: self-reported quality of life specific to head and neck cancer. It defines the scale direction, possible score range, summary parameter, and post-intervention assessment timeframes. However, it does not report numerical primary outcome results. No mean scores, change estimates, standard deviations, confidence intervals, or test results for FACT - H&N are reported in the registry record. Consequently, the size and precision of any change cannot be described from these entries.
The design also limits the kind of conclusion that a change estimate could support. This was a single-group pre-post evaluation, not a randomized or controlled comparison. In general, a within-group difference over time can show that measured outcomes changed among participants, but it does not establish that the intervention caused the change. Events occurring during the same period, natural change over time, changes in how participants report their experience, and other influences can also contribute. A comparison group would be needed to help distinguish intervention-associated change from these alternatives.
The record lists enrollment of 35, but it does not report the number of participants with primary outcome data at each assessment. The adverse-event record separately lists 30 participants at risk; the reason that denominator differs from enrollment is not reported in the registry record. Neither enrollment nor the safety denominator can substitute for the missing endpoint-specific sample sizes.
The primary outcome description mentions overall scores and subsets, and the registry lists assessment at two post-intervention timeframes. It does not report which estimates were obtained, how comparisons across times or subsets were handled, or whether any adjustment for multiple analyses was planned. The record lists three outcome measures and zero analyses. Statistical methods, analysis populations, and missing-data procedures are not reported in the registry record.
The registry status is completed, but completion status does not supply outcome evidence. The posted information supports a description of the pilot’s purpose, design, and intended measurement. It does not support a numerical judgment about the observed quality-of-life change or its statistical uncertainty.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The primary outcome is specified as a mean on a continuous score, with a standard deviation as its measure of dispersion. In general, the mean describes the average score or average change in a group. The standard deviation describes the spread of participant scores around the mean; it is not the uncertainty of the mean itself. A standard deviation can help readers understand whether participant responses were relatively similar or varied, but it does not indicate the precision of the group estimate on its own.
The registry describes FACT - H&N as ranging from 0 to 148, with higher values indicating higher self-reported quality of life. It does not give observed means or standard deviations. It also does not report a confidence interval, which would ordinarily communicate uncertainty around an estimate. As a general concept, a confidence interval represents a range of values compatible with the data and the method used, under the assumptions of that method. No interval for the primary outcome is reported in the registry record, so its precision cannot be evaluated.
How should change be understood in a pre-post study?
In general, a pre-post outcome compares measurements from the same group at different times. A change estimate can be expressed as a difference between the group’s measurements, or summarized from individual participants’ changes. The registry record states that the primary endpoint is change, but it does not describe the exact calculation used. It lists post-intervention assessments at 1 week and 1-2 months; the baseline measurement schedule and the specific contrasts intended for analysis are not reported in the registry record.
A single-group change estimate is descriptive of the observed group and period. Without a control group, it does not isolate what would have happened in the absence of the intervention. General sources of ambiguity include natural changes over time, other care or experiences during follow-up, changes in participant expectations, and regression to the mean. These are design considerations, not claims that any particular influence occurred in this pilot.
What can a significance test or confidence interval add?
General statistical interpretation distinguishes the estimated size of an effect from the uncertainty around it. A test result alone would not describe the magnitude of change, and a small p-value would not establish that the intervention caused the change in a single-group design. Conversely, a result that is not statistically distinguishable from no change would not prove that the true change is exactly zero. For this study, the registry record does not report a primary outcome test, p-value, or confidence interval. No significance conclusion can be drawn from the registry information.
What does the sample-size illustration represent?
The record’s sample-size assumptions describe a planning illustration based on an observed effect. They specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. This framework is different from the registered single-group pre-post design: the trial did not have two randomized arms or equal allocation between arms. The illustration therefore should not be read as the actual design or as evidence of the study’s achieved power.
In general, planning sample sizes estimate how many participants would be needed under specified assumptions to detect a target effect with a chosen power. They are planning quantities, not observed results. The numerical planning outputs and the fractions of the observed effect are not reported in the registry record. A sample-size justification for the pilot itself is also not reported in the registry record. No observed-power conclusion follows from the illustration.
Why can over-dispersion matter?
As a general statistical concept, over-dispersion occurs when observed variability is greater than a model assumes. It can make standard errors too small if the model fails to account for the extra variability, leading to overconfident inference. This consideration is most relevant when an analysis uses a model whose assumptions include a particular variance structure. The registry record does not describe a model for the continuous primary outcome or report evidence of over-dispersion, so no claim about its presence or handling can be made for this trial.
More broadly, the registry identifies the outcome’s intended summary as mean and standard deviation but does not give an analysis plan. It does not state whether change scores, repeated-measures methods, covariate adjustment, or other procedures were used. Those methods cannot be inferred from the outcome description alone. The available statistical interpretation is therefore limited to the stated design and measurement intentions.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures and identifies FACT - H&N change as the primary outcome. It names change in goal performance, satisfaction, and self-efficacy as a secondary outcome. The primary outcome description also refers to changes in an overall score and subsets, and the primary timeframe includes two post-intervention assessments. The record does not explain how many specific comparisons were planned across outcomes, subsets, or timeframes, nor does it report a strategy for controlling the chance of false-positive findings when multiple comparisons are made.
Multiplicity is a general concern when many outcomes or comparisons are examined: the more results considered, the greater the chance that an apparently notable result may arise by chance. This does not mean that the pilot necessarily made multiple statistical tests. The registry lists zero analyses, and the analysis procedures are not reported in the registry record. No multiplicity adjustment can be identified from the posted information.
Missing-data handling is also not reported in the registry record. There is no description of how missing scores were treated, whether participants with incomplete assessments were included in particular analyses, or whether any sensitivity analyses were performed. The analysis population is not reported. Enrollment was 35, but endpoint-specific counts at each assessment are not stated. The safety record uses 30 as the number at risk; the reason for that denominator is not reported and it should not be assumed to represent the primary outcome analysis population.
These omissions matter because missing observations and analysis choices can affect both the estimate and its uncertainty. Without the methods and outcome-specific denominators, readers cannot assess whether the reported participants, if any, represent all enrolled participants or how incomplete follow-up might influence an estimate. The registry record does not report the numerical primary or secondary outcome results needed to examine these issues empirically.
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 |
|---|---|---|---|
| Rehabilitation Consult (RC) | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Rehabilitation Consult (RC) | 0 of 30 |
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 |
|---|---|
| Rehabilitation Consult (RC) | 0 of 30 |
The adverse-event record lists the Rehabilitation Consult group with 30 participants at risk. It reports 0 participants affected by a serious adverse event, 0 affected by other adverse events, and 0 deaths. No serious adverse-event terms are listed. These are event counts as recorded, not estimates of the likelihood of an event in other populations or settings.
Enrollment was 35, whereas the safety denominator is 30. The reason for this difference is not reported in the registry record. The safety figures should therefore be read using the stated at-risk denominator, without assuming that all enrolled participants contributed to safety follow-up or that the denominator matches the outcome analysis population. The duration and completeness of safety observation are not reported in the registry record.
As a general statistical point, observing zero recorded events does not establish that the underlying risk is zero. It means that no affected participants or deaths were reported in the stated group and record. With no further information about follow-up or event ascertainment, these figures give only a limited account of safety during the recorded evaluation.
12. What the Result Does, and Does Not, Mean
The registry record establishes that Rehabilitation Consult was pilot-tested in a single-group pre-post evaluation and that the primary outcome was intended to capture change in cancer-specific self-reported quality of life. It also documents the measure’s direction and range, the planned post-intervention timeframes, and a secondary outcome concerning goal performance, satisfaction, and self-efficacy. These features describe the question and measurement approach, not the result.
The record does not report numerical FACT - H&N results. It therefore does not show whether the group’s scores increased, decreased, or remained similar, and it does not show how variable or precise any estimate was. The record also does not provide numerical results for the named secondary outcome. No conclusion about the magnitude or statistical significance of outcome change can be drawn from the registered information.
Even if a within-group change estimate were available, the design would not establish that the intervention caused that change. A single-group pre-post study lacks a concurrent comparator, so other changes over time or participant experiences could contribute. The design is appropriate to describe a pilot evaluation, but it does not provide a randomized treatment-effect comparison.
The zero adverse-event counts describe what the registry reports for 30 participants at risk. They do not prove an absence of risk, particularly because event observation duration and the reason for the safety denominator are not reported. The completed status indicates the study is recorded as completed; it does not fill gaps in outcome results or analysis methods.
In short, the registry record supports a description of the intervention’s aims, the pilot design, and the intended outcomes. It does not support a quantified conclusion about quality-of-life change, causal impact, or the precision of an outcome estimate.
13. Why This Trial Matters Statistically
This pilot is statistically important as an example of how a rehabilitation program can be evaluated with participant-reported outcomes and a pre-post framework. The stated program goals extend beyond measuring a single score: they include knowledge of rehabilitation needs and resources, individualized goal setting, action planning, and support for implementing and evaluating those plans. The named secondary outcome likewise concerns goal performance, satisfaction, and self-efficacy. These constructs can complement a disease-specific quality-of-life measure when considering the aims of a rehabilitation service.
The design also illustrates a key distinction between describing change and estimating an intervention effect. A single-group pre-post evaluation can be useful for an early pilot assessment, but it does not supply a concurrent counterfactual. A measured change would be compatible with several explanations, not only the intervention. Recognizing that distinction prevents descriptive follow-up from being overstated as a comparative causal result.
The registry record further illustrates why outcome descriptions and outcome results must be kept separate. It specifies FACT - H&N, its scale direction and range, and the intended timeframes, but does not report numerical results or analysis methods. Readers can understand what was intended to be measured without being able to judge the observed magnitude, variability, or precision.
Finally, the sample-size assumptions describe a two-arm planning illustration, whereas the registered pilot is single-group. Treating that illustration as a design feature or as observed power would misrepresent the study. A clear account of design, denominators, missing data, analysis populations, and outcome estimates is essential for interpreting pilot evidence. In this record, several of those statistical details are not reported, so interpretation appropriately remains focused on the study’s documented aims and structure.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations specific to this evaluation constrain interpretation. First, the registered design is single-group and pre-post, with no control arm. This means any observed change would not have a concurrent comparison against which to distinguish intervention-associated change from other influences over time. Allocation is listed as NA and masking as none, consistent with the absence of a randomized comparison.
Second, the registry record does not report numerical results for the primary endpoint. It does not give observed FACT - H&N scores, change estimates, standard deviations, confidence intervals, or statistical tests. It also does not report numerical results for the secondary outcome. The record therefore cannot support conclusions about the direction, magnitude, or precision of outcome changes.
Third, enrollment of 35 does not establish how many participants contributed primary outcome data at each assessment. The adverse-event record lists 30 participants at risk, and the reason for the difference from enrollment is not reported in the registry record. Outcome-specific denominators, follow-up completeness, and the analysis population are not reported.
Fourth, the registry does not describe the baseline assessment schedule, detailed outcome-analysis procedures, missing-data methods, or handling of multiple outcomes, subsets, and timeframes. These omissions prevent evaluation of how estimates were derived and how sensitive they might be to analysis choices.
Finally, the record gives limited detail about participant eligibility, the intervention’s specific delivery, and the duration of safety observation. These details are not reported in the registry record, so the evaluation’s implementation and the scope of its safety findings cannot be fully characterized from the registered information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Development and Evaluation of Rehabilitation Consult for Survivors of Head and Neck Cancer — NCT02836769.
- Registry record last updated 2021-09-17; status last verified 2021-08.
- Results first posted 2021-09-17.
- 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
This completed pilot evaluation examined Rehabilitation Consult for survivors of head and neck cancer in a single-group pre-post design. Enrollment was 35. The sponsor was Sunnybrook Health Sciences Centre, with study start listed as 2016-01 and primary completion as 2017-12. Allocation was listed as NA and masking as none.
The primary outcome was change in FACT - H&N, a cancer-specific self-report measure of quality of life, with post-intervention assessments listed at 1 week and 1-2 months. Change in goal performance, satisfaction, and self-efficacy was named as a secondary outcome. The registry record does not report numerical outcome results, analysis methods, missing-data procedures, or analysis populations.
The safety record lists 30 participants at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths. The reason for the difference between enrollment and the safety denominator is not reported in the registry record. The study’s single-group design permits no randomized comparison, and the posted information does not quantify primary outcome change.