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 Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors (NCT06654245), a na na study. The primary outcome is SHAREDCare's Qualitative Acceptability.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06654245 |
| Phase | NA |
| Condition | Stage I Lung Cancer, Stage II Lung Cancer, Stage III Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns lung cancer survivors, with the registry listing Stage I, Stage II, Stage III, and Stage IV lung cancer. Enrollment was 5. The record does not describe further eligibility details or characteristics of the participants.
Intervention
SHAREDCare brings a patient together with a navigator to review identified distress and social needs and develop a shared response plan. The plan is intended to set goals, anticipate barriers, and guide follow-up and adjustment of support. The listed study activities include a telephone-based interview, a questionnaire, electronic health record review, and referral.
Comparator
There is no separate control group. The design is single-group, and allocation is recorded as not applicable. The supportive care arm also receives standard-of-care automated referrals, so the registry does not describe an isolated comparison of SHAREDCare with usual care.
Primary question
The primary outcome asks about SHAREDCare’s qualitative acceptability at 4 weeks post-initial call. Semi-structured interviews are intended to elicit participants’ views, with analysis guided by Grounded Theory. The registry’s brief result statement says patients value coordinated support, while noting concerns about role fit, timing, and screening alignment. It does not report participant-level counts or a comparison group for this outcome.
3. Trial Design
This is a pilot study of an integrated approach to assessing and addressing follow-up care needs among lung cancer survivors. The registry identifies a single-group model, no masking, and allocation recorded as not applicable. It lists a SHAREDCare supportive care arm, with enrollment of 5. The study is not a randomized comparison, and the record does not provide a like-for-like control arm.
The intervention is centered on a navigator call in which patients discuss identified distress and social needs and work on a shared response plan. The registry describes the plan as taking account of patients’ current behaviors, beliefs, and motivation, identifying patient goals and potential barriers, and setting out follow-up and adjustment of care or assistance. The listed activities also include a questionnaire, electronic health record review, and referral. The arm description in the registry record is incomplete, so further details of the intervention schedule are not reported in the registry record.
The primary outcome is qualitative acceptability, assessed through semi-structured interviews at 4 weeks post-initial call. Grounded Theory is named as the guiding approach for inductive coding and developing themes. Secondary outcomes listed include quantitative acceptability, feasibility, and appropriateness, survivor unmet needs, referrals made and completed, enrollment, and completion of follow-up visits. Results for those secondary outcomes are not reported in the registry record.
The study is marked terminated. Its start date is 2025-06-11, and its primary completion date is 2026-01-12. The reason for termination is not reported in the registry record. The record does not report a phase, a sample-size justification, or a statistical analysis plan.
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 | SHAREDCare Supportive Care Arm |
|---|---|
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Results: Patients value coordinated support, but role fit, timing, and screening alignment concerns exist
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 | SHAREDCare Supportive Care Arm |
|---|---|---|
| Participants analysed | 5 | |
| Age, Customized: Mean age in years | Age in Years | 70.8 (SD 9.1) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as SHAREDCare's Qualitative Acceptability, measured over At 4 weeks post-initial call.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is SHAREDCare’s qualitative acceptability, assessed at 4 weeks post-initial call. The registry describes semi-structured interviews and an inductive Grounded Theory approach: interview material is coded to develop themes, including themes that may relate to intervention components, timing, or delivery. The outcome is listed in participants, but it is not defined as a numerical rating or a threshold-based success measure.
Acceptability addresses how participants experience and judge an intervention. As a general concept, qualitative interviews can help explain what participants value, what aspects may be difficult to fit into care, and how they describe the intervention in their own words. That makes this outcome relevant to a pilot focused on coordinated support and follow-up needs. It differs from an endpoint that directly compares clinical outcomes between treatment groups.
The registry’s brief result statement says patients value coordinated support, while role fit, timing, and screening alignment concerns exist. It does not report interview counts, the number of participants contributing to the findings, a coding framework, or counts for individual themes. Therefore, the statement can be read as a qualitative summary, not as a quantified estimate of how common each view was. Additional detail about endpoint definitions and interview completion is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry’s brief result statement offers a qualitative signal about how coordinated support was perceived: patients value it, while concerns involving role fit, timing, and screening alignment were identified. Those statements describe reported themes, not a treatment effect. The record does not give a numerical acceptability estimate, theme frequencies, or a comparison with a control group. It therefore does not establish how often each view occurred or whether perceptions differed from another care approach.
Enrollment was 5, and the study used a single-group design. That context is important when reading the findings. The record does not support a causal comparison between SHAREDCare and another intervention or usual care. Participants also received standard-of-care automated referrals according to the arm description, so any experience captured in the study is situated within the described package of support rather than a clean comparison of one component against another.
The stated primary outcome is qualitative acceptability at 4 weeks post-initial call. The methods described—semi-structured interviews and inductive coding—are suited to exploring participants’ accounts and generating themes. They do not, by themselves, provide a prevalence estimate or establish the magnitude of an effect. The registry does not report the number of interviews analyzed, participant-level outcome data, detailed themes, or analytic results. It also lists 9 secondary outcomes but reports no secondary outcome results in the record.
There are no analyses listed in the registry record. No confidence interval, p-value, or adjusted estimate is reported for the primary outcome. This should not be interpreted as evidence of no effect; it means the record does not provide an inferential estimate to assess. Likewise, the qualitative summary should not be treated as proof that the intervention improves follow-up care. The study description presents that as a rationale or possibility, but the posted result statement is about perceived support and concerns, not a demonstrated improvement in care.
The status is terminated, but the reason is not reported in the registry record. Without a reported reason or complete outcome data, it is not possible to determine whether termination was related to recruitment, feasibility, intervention delivery, or another factor. Overall, the record is most useful as a description of a small pilot and its qualitative acceptability signal. It cannot establish comparative effectiveness, quantify the distribution of views, or show whether the listed secondary outcomes were achieved.
9. Statistical Methods Explained
What does the design allow?
A single-group study observes participants receiving a study intervention without a concurrently assigned control group. In general, such a design can describe delivery, experiences, and outcomes in the enrolled group. It cannot separate the intervention’s effects from other explanations as effectively as a randomized comparison. Here, allocation is recorded as not applicable, the model is single group, and the registry explicitly does not describe a like-for-like control comparison. The findings should therefore be read as within-study observations rather than as a randomized estimate of comparative benefit.
What does qualitative acceptability measure?
Qualitative acceptability uses participants’ accounts to explore how an intervention is experienced and understood. Semi-structured interviews use a set of guiding topics while allowing relevant issues to emerge in conversation. The registry names Grounded Theory, a general approach that uses inductive coding to develop themes from data. In inductive analysis, researchers organize material into concepts and patterns rather than testing only a prespecified numerical hypothesis. Such findings can clarify issues such as role fit, timing, or alignment between screening and support. They do not automatically establish how frequent a theme is in a larger population.
The registry describes the primary outcome as a count of participants, but the stated assessment is qualitative. It does not report a threshold defining an acceptable response or the number of participants contributing each view. Without those details, the brief statement about coordinated support and concerns cannot be converted into a participant-level rate. The record also does not report coding procedures in enough detail to assess how themes were generated or checked.
How should quantitative outcomes be distinguished?
The listed secondary outcomes include quantitative acceptability, feasibility, and appropriateness, total survivor unmet needs, numbers of referrals made and completed, enrollment, and completion of follow-up visits. These are conceptually different from interview themes. A questionnaire outcome generally requires a defined score or response rule; counts of referrals require a defined observation period and a consistent way of identifying referrals; follow-up completion requires a clear definition of what counts as a completed visit. Detailed definitions and numerical results for these outcomes are not reported in the registry record. The list of outcomes alone does not show whether they were measured or what their values were.
What do confidence intervals and p-values ordinarily add?
As a general statistical concept, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, but neither the interval nor its width resolves design limitations such as the lack of a comparison group. A p-value is a measure tied to a statistical test and its assumptions; it is not the probability that a treatment works. Neither a confidence interval nor a p-value is reported for the primary endpoint in this record, and no analyses are listed. There is consequently no inferential estimate to interpret.
What is over-dispersion?
As a general concept, over-dispersion occurs when count data vary more than an analysis model expects. If present, standard errors and confidence intervals from a model that assumes less variability can be misleading. This issue can matter for outcomes such as counts of referrals or events, depending on their distribution and the analysis method. The registry record does not describe an analysis of these count outcomes or report a model, so over-dispersion cannot be evaluated for this study. It should not be assumed to have occurred.
How do planning illustrations differ from trial results?
The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such illustrations are hypothetical calculations for planning a future comparison; they are not observed power and do not describe the design actually registered for this pilot. In particular, the trial is single-group and has no like-for-like control arm, whereas the illustration assumes two arms with equal allocation. No numeric illustration values are included in the record information described for this analysis, and the registry does not report the trial’s own sample-size justification. These planning assumptions should not be used to infer that the pilot was powered for a particular test or that a treatment effect was established.
More broadly, statistical methods are interpretable only when linked to a clearly defined endpoint, analysis population, and estimate. The registry provides the primary outcome’s interview approach but does not report a detailed analysis plan, participant flow, missing-data procedures, or inferential results. Those omissions limit assessment of precision and reproducibility, rather than demonstrating a particular statistical outcome.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 9 secondary outcomes alongside the qualitative primary outcome. They cover quantitative acceptability, feasibility, and appropriateness; survivor unmet needs; referrals made and completed; enrollment; and completion of follow-up visits. The registry record does not report results for these secondary outcomes, nor does it list analyses. It also does not describe a multiplicity strategy, such as how interpretation would account for examining several outcomes. That information is not reported in the registry record.
As a general statistical concept, multiplicity arises when multiple outcomes or tests are considered. Looking across many tests can make apparently notable findings more likely to occur by chance, depending on the analysis and decision rules. Adjustments or a prespecified hierarchy can help manage that issue, but the appropriate approach depends on the study’s aims. The record does not provide enough information to determine whether any such plan was used. With no analyses or estimates reported, there are no p-values or confidence intervals to interpret for multiplicity.
Missing-data handling and analysis populations are also not reported in the registry record. It does not state how many participants completed the interview, whether all enrolled participants contributed to each outcome, how incomplete questionnaires or follow-up visits were handled, or whether any imputation or sensitivity analysis was planned. Those details matter because the people with available outcome data may differ from those without them. The registry does not provide participant flow or outcome-specific denominators, so completeness cannot be assessed from the reported information.
The study’s terminated status does not, on its own, explain whether outcomes were unavailable because of early termination or for another reason. The reason for termination and its impact on data collection are not reported in the registry record. These limitations mean that no conclusions about missingness mechanisms, analysis populations, or multiplicity-adjusted findings can be drawn.
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 |
|---|---|---|---|
| SHAREDCare Supportive Care Arm | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SHAREDCare Supportive Care Arm | 0 of 5 |
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 |
|---|---|
| SHAREDCare Supportive Care Arm | 0 of 5 |
The registry reports 5 participants at risk in the SHAREDCare supportive care arm. It records 0 serious adverse events, 0 other adverse events, and 0 deaths. These are the event counts reported for the group, not a comparative safety estimate. There is no separate control group in this single-group study.
As a general statistical point, event counts describe what was recorded in the participants observed; they do not establish that an event is impossible or that an intervention is free of risk. With enrollment of 5, the record offers limited information about uncommon events. The registry does not give further details about safety surveillance, the observation period for adverse events, or event definitions beyond the reported categories. It also does not report any serious adverse event terms. The reported zeros should therefore be read narrowly as no events recorded in the stated categories for this group, not as proof of safety.
12. What the Result Does, and Does Not, Mean
The posted result statement conveys that patients valued coordinated support while identifying concerns about role fit, timing, and screening alignment. This is potentially useful information for understanding how a navigator-supported care approach was experienced in this pilot. It draws attention to the possibility that the fit and timing of support, as well as how needs are identified, matter to participants’ accounts.
That summary does not establish that SHAREDCare improves follow-up care. The registry describes the intervention’s intended purpose, but the primary result presented is qualitative acceptability, not a controlled comparison of follow-up outcomes. No comparative group is reported, and no numerical effect estimate, confidence interval, or p-value is listed. The record does not quantify the proportion of participants who valued support or raised each concern. Nor does it give results for the listed secondary outcomes, including unmet needs, referrals, and follow-up completion.
The study enrolled 5 participants and is marked terminated. The reason for termination and the completeness of outcome collection are not reported in the registry record. These features constrain how broadly the findings can be interpreted. A brief qualitative summary can identify issues worth examining, but it cannot show how common those issues would be among a wider population or whether the intervention performs better than another care approach.
The registry record therefore supports a limited interpretation: it reports a favorable view of coordinated support alongside concerns that may inform future evaluation. It does not establish a clinical benefit, prove that concerns can be resolved, or determine whether a particular component of the intervention drove participants’ views. The record’s rationale and intended goals should be kept distinct from the reported outcome information.
13. Why This Trial Matters Statistically
This study is statistically informative partly because it illustrates the difference between an intervention’s promise and the question actually measured. The registry describes SHAREDCare as a way to identify distress and social needs, make a shared response plan, and support follow-up. Its primary endpoint, however, is qualitative acceptability at 4 weeks post-initial call. Acceptability can reveal how participants experience the approach, but it is not itself a comparative measure of improved care.
The single-group design also sets a clear boundary on inference. Without a control group, the study cannot estimate how outcomes would differ under another care strategy. The registry’s description of automated referrals as part of the supportive care arm further means the observed experience belongs to the intervention package described, not necessarily to one isolated component. This distinction is important when interpreting the brief positive account of coordinated support alongside concerns about role fit, timing, and screening alignment.
The record lists a range of secondary measures that could describe implementation and follow-up, including feasibility, appropriateness, referrals, unmet needs, and follow-up completion. Yet their results and the analysis methods are not reported in the registry record. A complete account of those measures would help distinguish whether the approach was deliverable, acceptable, and associated with changes in care processes. In the current record, those questions remain unanswered.
Finally, the enrollment of 5 and terminated status underscore why pilot findings should be treated as preliminary. The registry does not report a sample-size justification or reason for termination. Planning illustrations based on a hypothetical two-arm comparison do not change the single-group design and are not observed power. Statistically, the value of this record lies in its description of a small pilot and its qualitative issues—not in a definitive estimate of effectiveness.
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 main limitation is the single-group design. There is no like-for-like control comparison, so the registry cannot support a comparative estimate or isolate the effects of SHAREDCare from other aspects of care. The supportive care arm description includes standard-of-care automated referrals, making it particularly important not to attribute any experience to a single component without evidence.
Enrollment was 5, and the study is marked terminated. The reason for termination, participant flow, and the extent of outcome completion are not reported in the registry record. The primary outcome is a qualitative interview assessment, but the record does not report the number of interviews analyzed, detailed themes, coding results, or how many participants expressed each view. The brief result statement is therefore difficult to evaluate for completeness and cannot be interpreted as a frequency estimate.
The record lists 9 secondary outcomes but reports no analyses or secondary outcome results. Definitions for quantitative measures, outcome-specific denominators, missing-data methods, analysis populations, multiplicity handling, and the statistical analysis plan are not reported in the registry record. A sample-size justification is also not reported. The planning assumptions describe an equal-allocation two-arm illustration, which does not match the registered single-group model and should not be taken as a trial-specific power calculation.
The registry’s stated conditions cover Stage I through Stage IV lung cancer, but the characteristics of the enrolled participants and other eligibility details are not reported. That limits assessment of how representative the enrolled group may be. Together, these gaps restrict conclusions about intervention delivery, the distribution of participant views, safety beyond the recorded events, and applicability beyond this pilot.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors — NCT06654245.
- Registry record last updated 2026-10-22; status last verified 2026-08.
- Results first posted 2026-10-22.
- 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 describes NCT06654245, a pilot study of SHAREDCare follow-up support for lung cancer survivors, sponsored by Wake Forest University Health Sciences. It lists a single-group model, no masking, enrollment of 5, and a terminated status. The primary outcome is qualitative acceptability assessed through semi-structured interviews at 4 weeks post-initial call, guided by Grounded Theory.
The brief result statement says patients value coordinated support, while concerns about role fit, timing, and screening alignment exist. The record lists 9 secondary outcomes but no analyses. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 5 participants at risk in the supportive care arm. The reason for termination, detailed outcome results, missing-data methods, analysis populations, and statistical analysis plan are not reported in the registry record.