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 Involving Family to Improve Communication in Breast Cancer Care (NCT03283553), a randomized na study. The primary outcome is Between-group Differences in Patient Complete Illness Understanding at 9-months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03283553 |
| Phase | NA |
| Condition | Active Breast Cancer Treatment |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 132 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Results posted | Yes |
2. Clinical Question
Population
Patients receiving active breast cancer treatment and their family members or friends serving as companions. The primary-outcome analysis population is described as 118 patient-care-partner dyads with complete assessments at 9 months.
Intervention
A multicomponent communication intervention combining a patient-family agenda-setting checklist before a regularly scheduled oncology visit, facilitated registration for the patient portal, and education about access to clinicians’ electronic visit notes when relevant.
Comparator
Usual medical oncology care. The intervention description identifies care as usual with the medical oncologist as the comparator.
Primary question
At 9 months, how did the groups compare in the number of patients with complete illness understanding, defined as correct responses to all 4 questions? The registry record does not report the group-specific outcome counts or a treatment-effect estimate, so the direction and precision of the comparison cannot be described.
The trial focuses on communication and understanding in the context of active breast cancer treatment. Its intervention is directed at the interaction among patients, companions, and oncology clinicians, rather than at cancer treatment itself. The registry record also identifies patient and care-partner quality of communication at 9 months among the secondary outcomes.
The stated primary outcome is a threshold measure: perfect performance across questions about illness understanding, disease status, awareness of disease state, and expected duration of life. The comparison therefore concerns the proportion of patients reaching that threshold, rather than average performance across the four questions. No inference about whether the intervention improved communication or illness understanding can be drawn from the endpoint description alone.
3. Trial Design
The study is registered as a randomized, double-masked, parallel-group trial. It is listed as phase NA and was conducted in an outpatient oncology setting for people receiving active breast cancer treatment. The registry describes two groups: a multicomponent intervention and usual medical oncology care. The brief summary gives planned group sizes of 60 patient-companion dyads in each group.
The intervention includes a paper-and-pencil agenda-setting checklist completed immediately before a regularly scheduled medical oncology visit. The checklist is intended to elicit and align patient and companion perspectives about issues for discussion and to prompt discussion of the companion’s role. The other components are facilitated patient-portal registration for the patient and, if the patient wishes, a family member, and education about access to electronic visit notes when relevant. The comparator is usual care with the medical oncologist.
The study description says the trial was designed to examine protocol feasibility and compare communication quality, understanding of the patient’s cancer, confidence in managing the patient’s care, and satisfaction with cancer care. The primary outcome listed in the record is patient complete illness understanding at 9 months. Patient and care-partner quality of communication at 9 months are listed as secondary outcomes.
The registry lists enrollment of 132, a start date of 2017-07-20, primary completion on 2019-07-15, and completed status. The primary-outcome population is described separately as 118 dyads with complete assessments at 9 months. The record does not explain how that analysis population relates to enrollment or give a participant-flow account. Details of the masking procedure, randomization implementation, and allocation concealment 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.
Patient Participant Flow
| Stage | Multicomponent Intervention | Usual Care |
|---|---|---|
| STARTED | 69 | 63 |
| Patient Baseline Interview | 69 | 62 |
| Patient 3-Month Interview | 67 | 60 |
| Patient 9-Month Interview | 63 | 57 |
| Patient 12-Month Interview | 59 | 50 |
| COMPLETED | 59 | 50 |
| NOT COMPLETED | 10 | 13 |
Reasons for not completing this period:
| Reason | Multicomponent Intervention | Usual Care |
|---|---|---|
| Death | 5 | 10 |
| Withdrawal by Subject | 4 | 2 |
| Lost to Follow-up | 1 | 1 |
Care Partner Participant Flow
| Stage | Multicomponent Intervention | Usual Care |
|---|---|---|
| STARTED | 69 | 63 |
| Care Partner Baseline Interview | 69 | 63 |
| Care Partner 3-Month Interview | 69 | 60 |
| Care Partner 9-Month Interview | 64 | 55 |
| Care Partner 12-Month Interview | 59 | 48 |
| COMPLETED | 59 | 48 |
| NOT COMPLETED | 10 | 15 |
Reasons for not completing this period:
| Reason | Multicomponent Intervention | Usual Care |
|---|---|---|
| Withdrawal by Subject | 4 | 3 |
| Lost to Follow-up | 1 | 1 |
| Discontinued because patient death | 5 | 11 |
Analysis population for the primary outcome, as defined in the registry: The analysis sample includes the 118 patient-care-partner dyads with complete assessments at 9-months.
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: Overall Number of Baseline Participants include 69 dyads (one patient, one care partner) in the intervention arm and 63 dyads (one patient, one care partner) in the usual care arm, for a total of 132 dyads in the study. Baseline participant data for patient and care partner is reported here distinctly, where possible.
| Characteristic | Unit | Multicomponent Intervention | Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 69 | 63 | 132 | |
| Age, Continuous: Patient age | years | 55.1 (SD 13.4) | 52.9 (SD 14.5) | 54.1 (SD 13.9) |
| Age, Continuous: Care Partner age | years | 54.0 (SD 13.79) | 54.0 (SD 13.5) | 54 (SD 13.61) |
| Sex: Female, Male: Patient sex – Female | Participants | 68 | 63 | 131 |
| Sex: Female, Male: Patient sex – Male | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Care Partner sex – Female | Participants | 28 | 18 | 46 |
| Sex: Female, Male: Care Partner sex – Male | Participants | 41 | 45 | 86 |
| Ethnicity (NIH/OMB): Patient Ethnicity – Hispanic or Latino | Participants | 4 | 3 | 7 |
| Ethnicity (NIH/OMB): Patient Ethnicity – Not Hispanic or Latino | Participants | 64 | 60 | 124 |
| Ethnicity (NIH/OMB): Patient Ethnicity – Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Care Partner Ethnicity – Hispanic or Latino | Participants | 2 | 3 | 5 |
| Ethnicity (NIH/OMB): Care Partner Ethnicity – Not Hispanic or Latino | Participants | 65 | 60 | 125 |
| Ethnicity (NIH/OMB): Care Partner Ethnicity – Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Patient Race – American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Patient Race – Asian | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): Patient Race – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Patient Race – Black or African American | Participants | 12 | 14 | 26 |
| Race (NIH/OMB): Patient Race – White | Participants | 55 | 44 | 99 |
| Race (NIH/OMB): Patient Race – More than one race | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Patient Race – Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Care Partner Race – American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Care Partner Race – Asian | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Care Partner Race – Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Care Partner Race – Black or African American | Participants | 11 | 16 | 27 |
| Race (NIH/OMB): Care Partner Race – White | Participants | 55 | 40 | 95 |
| Race (NIH/OMB): Care Partner Race – More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Care Partner Race – Unknown or Not Reported | Participants | 2 | 3 | 5 |
| Region of Enrollment: United States | Participants | 69 | 63 | 132 |
| Breast Cancer Disease Stage: Early Stage Breast Cancer | Participants | 35 | 37 | 72 |
| Breast Cancer Disease Stage: Metastatic Breast Cancer | Participants | 34 | 26 | 60 |
6. Primary Endpoint
The registry lists the primary outcome as Between-group Differences in Patient Complete Illness Understanding at 9-months, measured over 9 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the count of participants who met the registry’s definition of complete illness understanding at 9 months. Understanding was assessed with four questions covering understanding of illness, knowledge of disease status, awareness of disease state, and expectation of duration of life. Each response was coded to indicate presence or absence of understanding, and the responses were summed to produce a score ranging from 0 to 4. Participants with a score of 4 were classified as having complete illness understanding; all others were grouped together.
This threshold creates a clear, interpretable binary outcome: a participant either met the perfect-score definition or did not. In general, a binary endpoint can make the comparison straightforward, but it does not retain distinctions among participants who fall short of the threshold. For example, it does not distinguish a score of 0 from a score of 3 in the reported primary classification. The registry record does not report the group-specific counts, proportions, or an effect estimate for this endpoint. It also does not report why the investigators selected this particular threshold, beyond defining complete understanding as 4 of 4 correct responses.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and specifies the primary endpoint, but it does not report the outcome results needed to quantify the comparison. In particular, there are no group-specific counts of participants achieving complete illness understanding, no effect estimate, and no confidence interval or p-value for the primary endpoint. The direction, magnitude, and statistical precision of the primary comparison therefore cannot be assessed from this record.
The stated primary analysis population is 118 patient-care-partner dyads with complete assessments at 9 months. That information identifies the population described for the endpoint, but it does not reveal how many participants in either group met the endpoint. Nor does it establish whether the results would be similar in participants without complete assessments. The registry record does not report how missing outcome data were handled or whether the analysis followed the randomized assignment regardless of intervention participation.
The brief summary describes planned groups of 60 dyads each, while total enrollment is listed as 132. These are distinct registry figures with different descriptions; they should not be treated as interchangeable. Safety entries also list separate numbers at risk for each arm. The record does not explain the relationship among the planned group sizes, total enrollment, primary analysis sample, and safety denominators.
The record lists 13 outcome measures and 13 analyses, but does not report a multiplicity strategy or identify which analyses were considered confirmatory. In a trial with several outcomes or analyses, multiple testing can increase the chance that at least one result appears notable by chance. Whether and how that issue was addressed is not reported in the registry record. The primary endpoint cannot be interpreted as evidence of a treatment effect without its actual comparison results and the analysis details.
Safety entries show zero serious adverse events and zero other adverse events in the listed at-risk groups, alongside deaths in both groups. These counts are descriptive. The record does not provide event details, attribution, timing, or a statistical comparison, so the entries do not establish whether any event was related to the intervention or whether safety differed between groups.
Overall, the available registry information describes the trial question, intervention, endpoint definition, analysis population, and selected safety counts. It does not support a conclusion about the intervention’s effect on illness understanding, communication, or any other outcome.
9. Statistical Methods Explained
A randomized parallel-group design assigns participants or groups to one of two interventions and compares their outcomes. Random assignment can help balance both measured and unmeasured participant characteristics across groups on average, but it does not guarantee balance in a particular trial. The registry identifies the study as randomized and parallel, but details of sequence generation, allocation concealment, and the unit of randomization are not reported in the registry record. The brief summary describes patient-companion dyads as the groups assigned to intervention or usual care.
What does the binary endpoint represent?
The endpoint classifies participants according to whether they answered all four illness-understanding questions correctly. In general, a binary outcome is commonly summarized by the number or proportion meeting a defined criterion in each group, followed by a between-group effect estimate. Common effect measures include a risk difference, risk ratio, or odds ratio; these measures answer different questions and can give different numerical impressions. The registry record does not report which measure was used for the primary comparison or provide the values needed to interpret one.
Reducing a score to a binary threshold has a trade-off. It provides a simple classification with a direct meaning, but discards information about how far participants were from the threshold. Participants below the perfect-score cutoff are combined, even though their underlying response patterns may differ. The registry record does not report an analysis of the full score as a continuous or ordinal measure.
How should uncertainty be considered?
In general, a confidence interval describes a range of effect values compatible with the observed data under the assumptions of the statistical method. Its width reflects precision: an interval that spans a broad range leaves more uncertainty about the size and possibly the direction of an effect than a narrow interval. A p-value, when reported, addresses the compatibility of the data with a specified null hypothesis under a statistical model; it is not a measure of clinical importance or the probability that a hypothesis is true. Neither a confidence interval nor a p-value for the primary comparison is reported in the registry record.
For a binary endpoint, precision is influenced by the number of participants and by how common the event is in each group. The record’s analysis population is 118 dyads with complete assessments at 9 months, but it does not report the outcome counts by group. Without those counts and the analysis method, a treatment-effect estimate and its uncertainty cannot be reconstructed from the endpoint description.
What does randomization not resolve by itself?
Randomization supports a fair comparison when allocation is implemented appropriately and outcomes are analyzed in a way that preserves the intended comparison. It does not, by itself, address missing outcome data, departures from assigned intervention, outcome measurement differences, or selective reporting. The registry record does not report enough detail to evaluate those issues fully. Although the design is described as double-masked, which parties were masked and how masking was maintained are not reported in the registry record. The behavioral components described may involve visible interactions, but the record does not specify how masking applied to participants, companions, clinicians, or outcome assessors.
How should planning illustrations be read?
In general, sample-size calculations use assumptions about the effect to detect, significance level, allocation, and statistical approximation to illustrate the number of participants that might be needed for a target power. The registry record describes planning illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are not observed power and do not establish the trial’s original sample-size justification. The record does not report the trial’s own sample-size justification. Any calculated planning figures should be understood as hypothetical planning scenarios, not as outcome findings or a post-trial measure of success.
The registry lists 13 outcome measures and 13 analyses. When several outcomes or comparisons are tested, multiplicity is a general statistical concern because the chance of at least one apparently positive finding can increase across tests. Approaches can include prespecifying a primary outcome, adjusting inference across tests, or clearly labeling analyses as exploratory. Which approach was used is not reported in the registry record. Consequently, even if individual results were available, their interpretation would depend in part on the analysis plan and the role assigned to each outcome.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and 13 analyses. It names patient complete illness understanding at 9 months as the primary outcome and identifies patient and care-partner quality of communication at 9 months as secondary outcomes. It does not describe a prespecified hierarchy among all outcomes, an adjustment for multiple comparisons, or which analyses were confirmatory rather than exploratory. Those details are not reported in the registry record.
In general, testing multiple outcomes or multiple versions of an analysis creates more opportunities for findings that appear notable by chance. A multiplicity adjustment can control a chosen error rate across tests, while a prespecified primary endpoint can help focus interpretation. The record does not say whether either strategy was used. The presence of a named primary outcome alone does not establish how all other analyses were handled.
The primary-outcome population is described as 118 dyads with complete assessments at 9 months. This indicates that the reported endpoint analysis was restricted to dyads with complete assessments, but the record does not state how many randomized participants lacked assessments, why assessments were incomplete, or how missing data were addressed. Imputation, sensitivity analyses, and comparisons of participants with and without complete data are not reported in the registry record.
The analysis population is described in dyads, while the endpoint is defined for participants. The registry does not explain whether both members of a dyad contributed outcomes, how any dependence within dyads was handled, or whether the analysis included all randomized participants in their assigned groups. These details matter for interpreting the unit of analysis and the influence of incomplete follow-up.
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 |
|---|---|---|---|
| Multicomponent Intervention | 0 | 69 | 0.0% |
| Usual Care | 0 | 63 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Multicomponent Intervention | 5 of 69 |
| Usual Care | 10 of 63 |
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 |
|---|---|
| Multicomponent Intervention | 0 of 69 |
| Usual Care | 0 of 63 |
The registry lists zero serious adverse events in the multicomponent-intervention group, with 69 at risk, and zero in the usual-care group, with 63 at risk. It also lists zero other adverse events in the groups, with the same respective numbers at risk. The record separately lists 5 deaths in the intervention group and 10 in usual care.
These are descriptive counts, not a statistical comparison. The registry record does not give event definitions, causes, timing, severity details beyond the serious-event classification, or judgments about whether events were related to the intervention. It does not explain why the safety denominators differ from the planned group sizes in the brief summary or how they relate to the 118 dyads described for the primary outcome.
The death counts should not be assumed to represent deaths caused by the intervention or to be included in either adverse-event category. The record does not provide that information. Zero recorded adverse events in these categories also does not establish that no other health events occurred or that the groups had equivalent safety. Without event-level context and an appropriate comparison, these figures are best read only as the counts and denominators entered in the registry.
12. What the Result Does, and Does Not, Mean
The record establishes that the trial compared a multicomponent communication intervention with usual medical oncology care in a randomized, double-masked, parallel-group design. It also defines complete illness understanding at 9 months and identifies an analysis population of 118 dyads with complete assessments. These details clarify what the primary endpoint was intended to capture and who was described as contributing to that analysis.
The record does not report the number of participants in either group who achieved complete illness understanding, nor does it report an effect estimate or uncertainty interval. It therefore does not show whether the intervention group had a higher, lower, or similar level of complete illness understanding. The same limitation applies to conclusions about the listed secondary outcomes, including patient and care-partner quality of communication: their names appear, but the record does not provide their results.
The endpoint is a specific threshold measure. It captures whether a participant answered all four questions correctly, not the full range of knowledge or communication experiences. A result on this measure, if reported, would not by itself establish effects on cancer status, treatment decisions, confidence, satisfaction, or other outcomes. The brief summary describes some of these as outcomes the study intended to compare, but the registry record does not report their results.
The safety counts also do not establish a causal relationship between the intervention and any event. The counts are not accompanied by event descriptions or comparative analyses. Overall, the registry record describes the study design and selected outcome definitions, but its available result information is insufficient to judge the intervention’s effects or their precision.
13. Why This Trial Matters Statistically
This trial addresses a statistical question involving communication processes and a patient-centered understanding measure rather than a conventional drug efficacy endpoint. Its intervention combines several components: agenda setting, portal registration, and education about electronic notes. The group comparison therefore concerns the intervention package as described; the registry record does not report analyses that separate the contribution of each component.
The endpoint definition illustrates how a complex concept can be operationalized for quantitative comparison. Illness understanding spans four areas, but the primary classification treats only a perfect score as complete understanding and groups all other scores together. This makes the criterion explicit while also limiting the detail retained in the binary outcome. The distinction matters when interpreting what an endpoint can and cannot represent.
The trial also highlights the importance of following the analysis population from enrollment through outcome assessment. The registry lists enrollment of 132, planned groups of 60 dyads each in the brief summary, and a primary analysis population of 118 dyads with complete assessments at 9 months. Because the record does not describe participant flow or missing-data handling, those figures cannot be reconciled from the registry entry alone.
Finally, the record names multiple outcomes and analyses without describing multiplicity handling or reporting the primary comparison results. A clearly defined endpoint is useful, but statistical interpretation also requires the group results, uncertainty, analysis methods, and context for missing observations. Without those elements, the trial’s stated question can be understood, but its answer cannot be evaluated from the registry record.
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 for interpretation is that the registry record does not report the primary outcome counts by group, the estimated between-group effect, or its precision. As a result, it is not possible to assess the direction or magnitude of the primary comparison. Outcome results for the listed secondary measures are also not reported in the registry record.
The registry gives an analysis population of 118 dyads with complete assessments at 9 months, but does not provide participant flow, reasons for incomplete assessments, or missing-data methods. It is therefore unclear how the analysis population relates to total enrollment of 132 and the planned groups of 60 dyads each. The record also does not describe adherence to the intervention, uptake of the portal or notes education, or whether participants were analyzed according to randomized assignment.
Important methodological details are not reported in the registry record, including the randomization procedure, allocation concealment, the parties covered by double masking, and the statistical method used for the primary comparison. The record lists 13 outcome measures and 13 analyses but does not describe a multiplicity strategy. These omissions limit assessment of risk of bias and the strength of any outcome-specific inference.
The intervention has multiple components, so a group-level comparison would not identify the effect of any one component unless additional component-specific analyses were conducted; such analyses are not reported in the registry record. The primary endpoint also compresses a four-question score into complete versus not complete, obscuring differences among participants who did not achieve the perfect score.
Safety counts are listed without event descriptions, attribution, timing, or a statistical comparison. The registry does not explain the safety denominators or their relation to other reported populations. These limitations are specific to the information available in the registry entry and do not, by themselves, establish that the trial lacked additional methods or analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Involving Family to Improve Communication in Breast Cancer Care — NCT03283553.
- Registry record last updated 2021-03-19; status last verified 2021-02.
- Results first posted 2021-03-19.
- 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
NCT03283553 is a completed randomized, double-masked, parallel-group study of a multicomponent communication intervention for patients receiving active breast cancer treatment and their companions. The intervention combined an agenda-setting checklist, facilitated patient-portal registration, and education about access to electronic visit notes when relevant; the comparator was usual medical oncology care.
The primary endpoint was patient complete illness understanding at 9 months, defined as correct responses to all four illness-understanding questions. The registry describes 118 dyads with complete assessments as the primary analysis population and lists patient and care-partner quality of communication at 9 months among the secondary outcomes.
The record does not report primary outcome counts or a treatment-effect estimate. It lists zero serious and zero other adverse events in both arms, and deaths of 5 and 10, respectively, without event-level context or a comparative analysis.