ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making) (NCT02929108), a randomized na study. The primary outcome is Change in Generalized Anxiety Disorder- 7.

2. Clinical Question

The clinical question concerns an educational and communication intervention for family caregivers, rather than a direct treatment for cancer or pain. The study description focuses on whether educating and supporting caregivers affects their active participation in shared decision making about the hospice patient’s plan of care. Anxiety is the primary outcome listed, while the registry also names outcomes concerning pain experience and knowledge, caregiver quality of life, perceived involvement, depressive symptoms, symptom assessment, caregiver burden and communication.

The three randomized groups allow the intervention to be considered alongside both enhanced usual hospice care and Facebook participation without shared decision making. However, the registry record does not report the group-specific anxiety scores, changes, estimates of between-group differences, or uncertainty intervals. It therefore does not establish from the posted results whether anxiety changed differently across the groups.

3. Trial Design

ACCESS was a completed, randomized, parallel-group trial sponsored by Washington University School of Medicine. The registry records an enrollment of 489. The three groups were Enhanced Usual Care, Facebook and ACCESS. Masking is listed as none. The registry identifies the study as not applicable for phase.

Enhanced Usual Care consisted of usual hospice care with an enhancement: staff had been trained in shared decision making. Caregivers in the Facebook group participated in Facebook groups but did not participate in shared decision making. Caregivers in ACCESS participated in Facebook and web conferencing for shared decision making. These descriptions distinguish the intervention components, but further details about delivery, frequency, duration or adherence are not reported in the registry record.

The primary outcome was change in Generalized Anxiety Disorder- 7 score. The stated assessment schedule began upon enrollment and continued at 14 days, 28 days, 60 days and 90 days. The scale is described as ranging from 0-21, with higher scores indicating higher anxiety. The registry also lists secondary outcomes on caregiver pain-related experience and knowledge, quality of life, perceived involvement, PHQ 9, symptom assessment, burden and communication.

Although the randomized parallel design can support comparisons among assigned groups, the registry record does not give the allocation ratio or group sizes for the primary outcome. It also does not report a statistical analysis plan or numerical primary outcome comparisons. The intervention descriptions and assessment schedule clarify what was intended to be compared and measured, but they are not substitutes for results. The start date was 2017-04-01, primary completion was 2021-11-22, and the record lists the trial status as completed.

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: Hospice patients were not enrolled to this study. Only family caregivers were enrolled to this study. Each family caregiver was only assigned to one group (intervention) and stayed in that group for the duration of their time in the study (up to 90 days). They were given surveys at 14, 28, 60, and 90 days. The number of family caregivers who received each intervention at each site is listed below.

Only the first 6 of 7 groups are shown.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Some questionnaires were not completed by the participant.

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 Change in Generalized Anxiety Disorder- 7, measured over Upon enrollment, 14 days, 28 days, 60 days and 90 days.

The primary endpoint is change in score on the Generalized Anxiety Disorder- 7, a screening tool described in the registry as quantifying participant anxiety. Its possible scale range is 0-21, and higher scores indicate a higher level of anxiety. Repeated measurement from enrollment through 90 days is intended to describe how scores evolve during follow-up, rather than capturing anxiety at only one assessment.

As a general statistical point, a change score expresses how a measurement differs from its earlier value. In a randomized study, comparing changes between groups can help distinguish patterns associated with assignment to different study conditions from patterns shared across the groups. That interpretation depends on the analysis method and on the completeness and timing of observations. The registry record does not report how change was calculated, which assessments were included in a primary comparison, or how repeated measurements were modeled.

The registry notes that some questionnaires were not completed by participants. This matters because a change estimate requires relevant measurements, and missing follow-up observations can affect which participants contribute to an analysis. The number of missing questionnaires, reasons for missingness, and methods for handling missing data are not reported in the registry record. Nor are the observed scores, changes, or uncertainty intervals. The endpoint is therefore clearly identified, but its observed results and precision cannot be assessed from the registry information available.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a mean, with standard deviation as the dispersion measure. A mean is a summary of the scores in a group, while a standard deviation describes how spread out individual scores are around that mean. As general statistical explanation, these summaries help characterize the observed scores, but they do not alone show whether randomized groups differ. A between-group estimate and its uncertainty are needed to describe the comparative result. The registry record does not report numerical means, standard deviations or comparative estimates for the primary outcome.

The Generalized Anxiety Disorder- 7 outcome is measured repeatedly: upon enrollment, 14 days, 28 days, 60 days and 90 days. Repeated observations are related because they come from the same participant. General statistical methods for repeated measurements account for this within-participant structure rather than treating every score as independent. The particular method used for this trial is not reported in the registry record. Neither the model specification nor the contrast used to summarize change is reported.

What does a between-group comparison represent?

In a randomized trial, a comparison between assigned groups is generally the relevant basis for assessing differences associated with the study conditions. A within-group change alone can reflect many influences over time, including influences shared by all groups. Comparing groups helps place those changes in context. This is a general explanation, not a description of an analysis documented for ACCESS: the registry record does not give a numerical comparison or identify the exact primary contrast.

What does a confidence interval add?

As a general concept, a confidence interval communicates uncertainty around an estimate. The point estimate describes the estimated difference or change, while the interval indicates how precisely that quantity has been estimated under the analysis. An interval that includes values in different directions may leave substantial uncertainty about the direction of a difference. Precision also depends on the outcome variability and the amount of information available. No confidence interval or effect estimate for the primary endpoint is reported in the registry record, so precision cannot be evaluated for this trial.

Why do repeated measurements and incomplete questionnaires matter?

The registry notes that some questionnaires were not completed. Missing outcome measurements may reduce the information available at particular assessments. As a general statistical matter, the consequences depend partly on why data are missing and how the analysis handles them. If missingness is related to participants’ scores or circumstances, an analysis restricted to completed questionnaires can represent a selected subset. Methods that use repeated observations or account for missingness rely on assumptions that should be stated. The registry record does not describe the extent or pattern of missing questionnaires, reasons for missingness, or the approach used to address it.

How should the sample-size illustration be understood?

The stated sample-size framework is a planning illustration based on an observed effect, not the trial’s original design justification. It specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. The registry record does not report the original sample-size justification, target power, or assumptions used to plan enrollment. Those details should not be inferred from a later illustration.

Such illustrations describe how many participants per arm would be needed under the stated assumptions to detect an assumed effect at a selected power. They are not observed power, and they do not show how likely the trial was to detect its actual effect. If the observed effect used as the starting point is uncertain, illustrations based on fractions of that effect inherit that uncertainty. Moreover, an equal-allocation, two-arm illustration does not directly describe the three-group structure unless a particular pairwise comparison is specified. No numerical illustration values or specified pairwise comparison are reported in the registry record.

What can be inferred from the analysis status?

The registry record reports zero analyses and identifies the multiple primary outcome time points as a reason not to reduce the endpoint to a single comparison. This means the available record does not provide an analyzed primary contrast that can be interpreted. It does not establish whether analyses were conducted elsewhere or whether a detailed plan exists outside the registry record. Statistical details such as model choice, adjustment for baseline scores, handling of multiple comparisons, analysis population and sensitivity analyses are not reported in the registry record.

Overall, the method fields establish the type of summary intended for a continuous score and the longitudinal assessment schedule. They do not supply the estimates or analytical specifications needed to reproduce or evaluate a comparative result. The distinction between a trial’s design, a planning illustration and observed analyses is important: design describes how groups were formed, planning assumptions describe hypothetical detection, and outcome analyses describe the estimates actually calculated from participant data.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is assessed at enrollment, 14 days, 28 days, 60 days and 90 days, and the randomized design has three groups. Considering multiple groups and assessment times can create multiple possible comparisons. As a general statistical concern, testing many comparisons can increase the chance of finding an apparently notable result by chance. Researchers may specify a primary contrast, sequence of tests or adjustment method to address that issue. Which comparisons were designated as primary, and whether any multiplicity adjustment was planned or used, are not reported in the registry record.

The registry lists several secondary outcomes, including caregiver pain experience and knowledge, quality of life, perceived involvement, PHQ 9, Edmonton Symptom Assessment, Zarit Burden Scale and caregiver communication. The record gives no numerical analyses for these measures. It also does not report how testing across secondary outcomes was handled, or whether those analyses were considered confirmatory or exploratory.

Missingness is relevant because the primary outcome description says some questionnaires were not completed. The number and timing of missing questionnaires, reasons for noncompletion, and methods for handling missing observations are not reported in the registry record. Without that information, readers cannot assess whether the available observations represent participants similarly across groups and follow-up times.

The analysis population is also not reported in the registry record. It is therefore unclear from the posted results whether analyses were based on all randomized participants, participants with completed assessments, or another defined group. Details about protocol deviations, exclusions, imputation, sensitivity analyses and interim analyses are not reported in the registry record. The registry also does not report a statistical analysis plan. These omissions limit assessment of the risk that analytic choices, missing data or multiple comparisons could affect interpretation.

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 adverse-event figures list zero participants with serious events, zero participants with other events and zero deaths in each group. The numbers listed at risk are 126 for Enhanced Usual Care, 214 for Facebook and 149 for ACCESS. No serious-event terms are listed.

These entries describe what the registry record reports; they should not be interpreted as proof that no adverse experiences occurred. A zero count can mean no events were recorded in the reported categories, but the available record does not explain event collection procedures, reporting thresholds, follow-up completeness or whether all events were actively solicited. It also does not provide event-level descriptions beyond the absence of listed serious-event terms.

The at-risk counts are associated with the adverse-event reporting and should not automatically be treated as the primary-outcome analysis denominators. The record does not report the number of participants contributing anxiety questionnaires at each assessment. Nor does it provide information about reasons participants may have stopped follow-up. The safety figures are therefore best read as registry-reported counts, not as a comprehensive measure of all possible harms or as a basis for comparing safety across groups.

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

The registry record establishes that ACCESS was a completed randomized trial involving caregivers of hospice cancer patients, with three groups and a primary anxiety outcome measured over follow-up. It describes how the groups differed: staff training in shared decision making for Enhanced Usual Care, Facebook participation without shared decision making for Facebook, and Facebook plus web conferencing for shared decision making in ACCESS. These details clarify the intended comparisons.

The record does not report numerical results for the primary outcome or analyses comparing the groups. It therefore cannot show whether anxiety scores changed, whether changes differed between groups, the size or direction of any difference, or how precise an estimate might be. It also cannot show whether any observed difference would be meaningful to caregivers or patients. Those questions require results and a clearly specified comparison, neither of which is reported in the registry record.

The absence of posted analyses is not evidence that the groups had identical outcomes. It is equally not evidence that an intervention improved or worsened anxiety. Without estimates and uncertainty, the result is undetermined from this record. The trial’s completion status and enrollment count describe conduct and scale, but they do not supply evidence about the primary endpoint.

The same limits apply to secondary outcomes and safety. Outcome names indicate the domains measured, not the direction or size of findings. The adverse-event entries show zeros in the listed categories, but the record does not provide enough detail to conclude that no adverse experiences occurred. These are limitations of what can be interpreted from the registry information, not conclusions about analyses or results that may exist elsewhere.

For a substantive interpretation, readers would need group-specific outcome summaries, comparative estimates with uncertainty, details of the repeated-measures analysis, missing-data handling, and information about which participants were included. Until such information is reported, the defensible conclusion is limited to the study question, design and registered outcome definitions.

13. Why This Trial Matters Statistically

This trial raises a statistical question that is common in behavioral and caregiver research: how to evaluate an intervention with several components against more than one comparison condition. ACCESS combines Facebook participation with web conferencing for shared decision making, while the Facebook group does not participate in shared decision making and Enhanced Usual Care includes staff training. The differences between arms make it important to state clearly which contrast is being estimated and what component that contrast represents.

The anxiety endpoint is longitudinal, with assessments at enrollment and several follow-up times. Repeated-measures data can describe patterns over time, but interpretation depends on the chosen summary and model. A single follow-up comparison, a change comparison and an overall trajectory comparison answer distinct questions. The registry record identifies the schedule but does not report which analysis defines the primary result. This illustrates why an outcome name and measurement schedule alone are insufficient for evaluating evidence.

The record also notes incomplete questionnaires. Missing observations are not merely a reporting detail: they can affect precision and, depending on the reasons for missingness, the meaning of an estimate. Clear reporting of how many measurements are missing, why they are missing and how analyses address them is important for readers assessing longitudinal results.

Finally, the registry lists a planning illustration based on an observed effect, while not reporting the trial’s original sample-size justification or numerical analyses. Keeping planning assumptions separate from observed findings helps prevent hypothetical detection scenarios from being mistaken for evidence. In this case, the key statistical lesson is the importance of transparent comparative results, specified contrasts, and sufficient information to assess uncertainty and missing data.

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 trial-specific details needed to interpret the primary outcome are not reported in the registry record. The record gives the measurement schedule but not the primary comparison, the statistical model, whether baseline score was included as an adjustment, or how changes were defined. With multiple groups and repeated assessments, the absence of a stated contrast makes it difficult to know which estimate would answer the principal clinical question.

The record notes that some questionnaires were not completed, but does not quantify missingness by group or time point. Reasons for noncompletion and methods for handling missing data are also not reported. This prevents assessment of whether missing observations could have changed the estimated pattern of anxiety scores. The analysis population is not reported, so it is unclear which participants would be represented in any analysis.

Although the trial is listed as randomized, the registry record does not report the allocation ratio or group sizes for the primary outcome. It also does not provide details about adherence to Facebook participation or web conferencing, intervention exposure, or departures from assigned conditions. Such details could help explain how the intervention was implemented, but they should not be assumed from the brief arm descriptions.

The primary endpoint has multiple assessment times, and the trial has multiple randomized groups. The record does not identify a single primary time-point comparison or report a plan for multiplicity. The analysis count is zero, and no numerical primary or secondary outcome results are reported. Together, these omissions prevent evaluation of effect size, precision, robustness and consistency across outcomes.

The registry’s adverse-event counts are also limited: the record does not describe ascertainment procedures or provide event details beyond the listed counts. These limitations apply to interpretation of the registry record and do not establish that additional information is unavailable elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making) — NCT02929108.
• Registry record last updated 2023-04-20; status last verified 2023-03.
• Results first posted 2023-04-20.
• 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

ACCESS was a completed, randomized, parallel-group trial sponsored by Washington University School of Medicine, with enrollment of 489 and no masking listed. It studied education and support for family caregivers of hospice cancer patients, using Enhanced Usual Care, Facebook and ACCESS groups. ACCESS included Facebook and web conferencing for shared decision making.

The primary outcome was change in Generalized Anxiety Disorder- 7 score, assessed upon enrollment and at 14 days, 28 days, 60 days and 90 days. The registry describes the score range as 0-21, with higher scores indicating higher anxiety. Some questionnaires were not completed.

The record lists secondary caregiver and patient-related outcomes, but reports zero analyses. Numerical primary outcome comparisons, uncertainty estimates, analysis methods, missing-data procedures and analysis populations are not reported in the registry record. Adverse-event entries list zero serious events, zero other events and zero deaths in each group; no serious-event terms are listed. The registry information supports description of the trial design and outcomes, but not a quantitative conclusion about the primary result.