Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling (NCT03225170), a randomized na study. The primary outcome is Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing.

2. Clinical Question

This question concerns a stated intention, not whether genetic testing was later completed. The trial also listed secondary outcomes concerning mammogram intention, anxiety, clients’ perceptions of the writing exercise and counseling visit, and engagement with the writing activity. The registry record gives the study objective as examining whether a self-affirmation exercise before counseling could improve client communication and behavior. The posted primary outcome, however, is specifically a count of clients indicating an intention to have genetic testing. It should therefore be interpreted as a measure of reported intention at the survey assessment, rather than as a direct measure of communication quality, subsequent behavior, or clinical outcome.

3. Trial Design

The registry describes a randomized, double-masked, parallel-group study. Its phase is listed as not applicable, and its status is completed. The recorded enrollment is 64. The listed condition is breast cancer, and the sponsor is the National Human Genome Research Institute. The study began on 2017-08-15, with primary completion recorded as 2020-06-29.

Participants were assigned to a self-affirmation writing exercise or a control writing exercise before genetic counseling. In the self-affirmation group, the activity focused on positive personal values; the control activity used a similar questionnaire with a non-affirming exercise. Clients were screened by phone before the appointment and were asked to arrive 15 minutes early. The registry describes a 10 to 15 minute survey and writing exercise before the appointment, followed by a 10- to 15-minute survey after counseling, either in the office or online.

The record identifies the target client population as adult women with an initial hereditary breast and ovarian cancer risk appointment with a genetic counselor at St. Luke's Health System. Genetic counselors providing this care were also included in the eligibility description. The primary outcome's stated analysis population consists of clients who were offered genetic testing during the counseling session and completed the post-counseling survey. Clients who were not offered testing were excluded from that outcome population.

The registry calls the design double-masked but does not report which people were masked or how masking was maintained. Details of sequence generation, allocation concealment, deviations from the intended intervention, and adherence are not reported in the registry record. The record also does not report the protocol details needed to determine how the planned analyses were specified or whether they changed during the study.

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.

Before assignment: Of the 64 participants consented to the study, 17 participants withdrew prior to randomization and 47 participants started the study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The analysis included clients who were offered genetic testing in the session and completed the post-genetic counseling session survey. Two clients, one in each arm, were not offered genetic testing.

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.

6. Primary Endpoint

The registry lists the primary outcome as Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing, measured over Assessed within 1 week after completing the genetic counseling session.

The primary endpoint is the number of clients who indicated an intention to have genetic testing. It was assessed within 1 week after the genetic counseling session, using a single survey item asking, “Do you plan to have genetic testing?” The response options were yes, maybe, and no. The record describes the endpoint as a count of participants, but does not report a result or explain how those response categories were handled for a single comparison.

An intention question can capture a participant's stated plan at the time of the survey. In general, intention is distinct from later behavior: a response does not establish whether testing was subsequently pursued or completed. It can still be relevant when a study is interested in decisions following counseling, because it records what a participant says she plans to do after receiving information. It does not, by itself, assess the quality of counseling, comprehension, or the reasons behind a decision.

The endpoint population is limited to clients who were offered genetic testing and completed the post-counseling survey. The record states that two clients, one in each arm, were not offered testing. It does not report the number of survey nonrespondents, the outcome counts by response category, or how missing responses were treated. Because no primary comparison is reported, the endpoint cannot establish whether intention differed between the randomized groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies random allocation, double masking, and a parallel-group model. These terms describe aspects of trial design, not the statistical result. In general, randomization assigns participants to groups through a chance process and is intended to make the groups comparable on average at assignment. A parallel design follows the assigned groups as separate groups rather than switching participants between interventions. Masking is intended to limit the influence of knowledge of assignment, but the registry does not say who was masked or how masking was implemented.

What is the outcome scale?

The primary outcome is described as a count of participants who indicated an intention to have genetic testing. The underlying survey item has yes, maybe, and no response options. Those are categorical responses, not a continuous measurement. A count can be formed for a response category or for a prespecified combination of categories, but the registry does not report which category or combination was used for a primary contrast. It explicitly notes that the primary outcome has several categories or time points and was not reduced to one comparison.

In general, a statistical comparison of categorical outcomes requires clarity about the categories being contrasted and the number of participants contributing to each category. The group-specific counts and denominators are not reported in the registry record. Without those details, a reader cannot reconstruct an unadjusted comparison or assess the amount of information available for each response.

What can a confidence interval convey?

In general, a confidence interval describes the range of effect estimates compatible with the observed data under a specified statistical procedure. Its width communicates precision: a wider interval indicates less precision, while a narrower interval indicates more precision. A confidence interval does not repair limitations in outcome definition, missing data, or study design. No primary estimate or interval is reported for this outcome, so precision cannot be evaluated from the registry record.

What does a significance test answer?

In general, a significance test evaluates how compatible the observed data are with a specified null hypothesis under the assumptions of the test. A p-value is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. A p-value also does not make an ambiguous outcome contrast clear. No primary test result is reported in the registry record; therefore, statistical significance cannot be assessed.

What is the role of the analysis population?

The record defines the primary outcome population as clients offered genetic testing during counseling who completed the post-counseling survey. That definition matters because it excludes people who were not offered testing and may exclude people without a completed survey. In general, analyses based on participants with observed outcomes can be affected if outcome availability is related to treatment assignment or participant characteristics. The registry does not report missing-outcome counts, reasons for missingness, or an approach to missing data, so the impact of incomplete follow-up cannot be assessed.

What can recalculation add?

A recalculated result based on posted summary statistics can sometimes provide a simple, unadjusted comparison that is distinct from a sponsor's own analysis. Such a calculation depends on sufficient reported group counts and a clearly defined contrast. Neither the necessary outcome counts nor a single primary contrast is available in the registry record. No recalculated primary comparison can therefore be interpreted. There is also no sponsor analysis reported for this outcome that could be compared with a recalculation.

How should planning illustrations be read?

In general, sample-size calculations describe assumptions about the amount of information a future study would need to detect a specified effect under a statistical model. They are planning illustrations, not evidence that an observed effect is real and not a measure of the probability that this completed study found a result. The registry describes planning assumptions based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It does not report a sample-size justification for the original trial in the registry record. No planning figures are included in the information available for interpretation, and the assumptions should not be mistaken for an analysis result.

For event-count outcomes in general, the statistical model should reflect how the data arise. Over-dispersion occurs when the observed variability is greater than a model expects; ignoring it can make uncertainty appear too small. The listed primary measure is a count of participants with a stated response, but the registry does not specify a statistical model for the primary outcome. There is no basis for asserting that an over-dispersion adjustment, a particular regression model, or a particular variance estimate was used.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures, including the primary outcome and secondary outcomes on mammogram intention, anxiety, perceptions of the writing exercise and counseling visit, and engagement with the writing activity. When a study examines multiple outcomes, response categories, time points, or contrasts, the chance of finding at least one apparently notable result can increase. In general, a prespecified analysis plan and an appropriate approach to multiplicity help readers understand which comparisons were primary and how other results should be interpreted.

The record states that the primary outcome has several categories or time points and was not reduced to one comparison. It reports zero analyses in its analysis count. The statistical analysis plan, any multiplicity adjustment, and any hierarchy or prioritization among secondary outcomes are not reported in the registry record. Consequently, the intended primary contrast and the treatment of multiple comparisons cannot be assessed.

The primary-outcome population is defined as clients offered testing who completed the post-counseling survey. The record identifies two clients, one in each arm, who were not offered testing, but does not report the number of missing surveys, the number analyzed by arm, or reasons for missing data. It also does not describe imputation, sensitivity analyses, or how incomplete responses to the yes/maybe/no item were handled. These omissions limit assessment of missing-data bias and the representativeness of the outcome analysis.

Although the record identifies randomized groups, it does not report whether the primary analysis followed assigned group regardless of intervention completion, or used another analysis population. That detail is not reported in the registry record. The available information therefore does not establish how participants with incomplete assessments or protocol deviations were handled.

11. 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.

The registry's adverse-event record lists the self-affirmation group with 23 participants at risk for serious adverse events and 23 at risk for other adverse events; both event counts are 0. For the control group, it lists 22 participants at risk for serious adverse events and 22 at risk for other adverse events; both event counts are 0. The death count is 0 in each group, and no top serious-event terms are listed.

These figures indicate that no serious or other adverse events, and no deaths, were recorded in the listed safety fields for the groups and participants at risk shown. They do not establish that no events occurred outside the registry's reporting definitions or observation period. The record does not give further information about event definitions, collection procedures, follow-up completeness, or the period used for safety monitoring.

In general, zero recorded events in a study does not prove that the risk of an event is zero. The amount of information about uncommon events depends on the number observed, the number followed, and how completely events were collected. The registry figures should therefore be read as reported counts, not as definitive evidence about safety or as a comparison demonstrating a difference between the writing exercises.

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

The registry record establishes the study question and design: a randomized comparison of a self-affirmation writing exercise with a non-affirming control before hereditary breast and ovarian cancer genetic counseling. Its listed primary outcome is participants' stated intention to have genetic testing, assessed within 1 week after counseling. The response options are yes, maybe, and no.

The record does not report the primary response counts, a group comparison, an effect estimate, a confidence interval, or a test result. It also notes that the primary outcome has several categories or time points and was not reduced to one comparison. These gaps mean the posted record cannot show whether the groups differed in testing intention or how precisely a difference was estimated. It cannot establish that the self-affirmation exercise changed intentions.

Even if a difference in stated intention were reported, that outcome would not by itself show whether clients later underwent genetic testing. Intention is a self-reported plan at the survey assessment, whereas subsequent behavior is a separate outcome. Nor would an intention result alone establish an effect on communication, understanding, anxiety, or other outcomes. The record lists several secondary outcomes, but does not report their results.

The completed status and enrollment figure describe the conduct and registration of the trial; they do not substitute for outcome data. The primary analysis was defined for clients offered testing who completed the post-counseling survey, while the number of analyzed clients and the handling of missing responses are not reported in the registry record. Thus, neither the completeness nor the representativeness of the primary outcome data can be determined from the available record.

The appropriate conclusion is limited: the trial was designed to evaluate a pre-counseling writing activity, but the registry information does not provide the results required to judge its effect on the stated primary outcome. It does not support a claim of benefit, lack of benefit, or equivalence between the groups.

13. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between an intervention's intended mechanism and the outcome used to evaluate it. A self-affirmation exercise was intended to support clients before counseling, while the listed primary endpoint records a stated plan about genetic testing. These concepts are related to decision-making but are not interchangeable. Clear outcome definitions help readers understand exactly what a trial can and cannot answer.

The endpoint is recorded through a question with yes, maybe, and no responses, while its title describes a count of clients indicating intention. A clear primary contrast would specify how these categories are treated. Without that specification and the observed category counts, the statistical question remains incomplete: the reader cannot tell what group difference was estimated or evaluate its uncertainty.

The study also illustrates why the analysis population matters. The registry restricts the primary outcome to clients offered testing who completed the survey. That makes the denominator and handling of nonresponse important to interpretation. Random allocation is valuable for comparative research, but it cannot eliminate uncertainty about outcomes that are not reported or clarify which participants contributed to an analysis.

Finally, a completed trial record is not the same as a complete statistical report. The registry identifies the design, intervention, outcome, and some safety counts, but does not report a primary result or analysis plan. For biostatisticians and clinical researchers, this distinction is central: design information helps frame a question, whereas estimates, uncertainty, and transparent analysis details are needed to answer it.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary limitation for interpretation is that the registry record does not report the primary outcome results. There are no response counts by group, analysis denominators, effect estimate, confidence interval, or test result. The record also says that the primary outcome has several categories or time points and was not reduced to one comparison, leaving the intended primary contrast unclear.

The response options are yes, maybe, and no, but the registry does not describe whether these were analyzed separately or combined. The outcome is an intention assessed within 1 week after counseling; later testing behavior is not the listed primary measure. Any interpretation should therefore remain specific to the reported intention question rather than extending to subsequent behavior or broader counseling effects.

The primary outcome population excludes clients who were not offered genetic testing and requires completion of the post-counseling survey. The record identifies two clients who were not offered testing, but does not report the number of missing surveys, group-specific analysis counts, reasons for missingness, or methods for incomplete responses. The effect of these exclusions and any missing data cannot be assessed.

The registry lists multiple outcomes but does not report a statistical analysis plan, multiplicity approach, or analysis population beyond the primary-outcome eligibility description. It also does not report adherence, allocation concealment, who was masked, or whether the intervention was delivered as intended. These details are not reported in the registry record, limiting assessment of potential bias and the exact analytical procedures.

The safety entries list zero serious events, zero other events, and zero deaths in the reported group fields, but details of safety monitoring and event definitions are not reported. The enrollment figure alone cannot establish the precision of a treatment-effect estimate or the completeness of safety follow-up. Taken together, the record supports description of the trial design but not a firm statistical conclusion about its primary outcome.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling — NCT03225170.
• Registry record last updated 2024-05-29; status last verified 2020-06-29.
• Results first posted 2022-01-11.
• 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.

18. Record Summary

The registry describes a completed, randomized, double-masked, parallel-group study of a self-affirmation writing exercise before hereditary breast and ovarian cancer genetic counseling. Enrollment is recorded as 64. The comparator was a similar non-affirming writing exercise. The trial began on 2017-08-15, and primary completion is recorded as 2020-06-29.

The primary outcome was the number of clients indicating an intention to have genetic testing within 1 week after counseling, measured by a yes/maybe/no survey item. The record limits this outcome population to clients offered testing who completed the survey, and identifies two clients, one in each arm, who were not offered testing.

The registry does not report the primary outcome counts, a group comparison, or an analysis plan. It lists zero serious adverse events, zero other adverse events, and zero deaths in the reported safety fields for each group. The posted information describes the study design, but does not provide the primary result needed to estimate the effect on stated testing intention.