The ConnectedCancerCare Pilot Study (CCC): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The ConnectedCancerCare Pilot Study (CCC) (NCT03618017), a randomized na study. The primary outcome is Number of Breast Cancer Patients Successfully Recruited to Participate in the Study.

2. Clinical Question

3. Trial Design

The ConnectedCancerCare Pilot Study (CCC) was a randomized, parallel-group pilot trial. The registry identifies allocation as randomized and masking as triple; it does not identify which people or roles were masked. The study is marked completed. Its enrollment is listed as 66, while the primary outcome description separately states an anticipated response rate of 80% enrollment (n=60). Those entries serve different purposes: the enrollment field is the registry’s overall enrollment figure, whereas the anticipated figure is part of the planned recruitment outcome description.

The two groups were the CCC website intervention and the static care plan control. The CCC website was described as a personalized navigation tool that took account of preferences about provider roles, satisfaction with the current primary care provider, and concern about cancer recurrence. The control was a static PDF survivorship care plan template. The registry classifies both interventions as behavioral.

The study was described as an NCI-funded randomized control pilot trial. It was intended to evaluate the feasibility and acceptability of the web-based tool and explore whether it improved delivery of team-based survivorship care for women recently finished with primary breast cancer treatment. The registry lists the phase as not applicable. It records a start date of 2018-08-08 and a primary completion date of 2019-08-30.

Details about the randomization procedure, allocation concealment, implementation of masking, and any deviations from the planned design are not reported in the registry record. Nor does the record describe a formal confirmatory efficacy objective. A pilot study’s stated feasibility purpose should therefore be kept distinct from evidence of a treatment effect: the design identifies how the groups were intended to be compared, but numerical outcomes are needed to interpret what happened.

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: 160 eligible women were invited to participate; 66 women enrolled (completed the baseline survey and were randomized).

Overall Study

Analysis population for the primary outcome, as defined in the registry: Number of eligible women invited to participate

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 Number of Breast Cancer Patients Successfully Recruited to Participate in the Study, measured over At baseline survey.

The primary endpoint was the number of breast cancer patients successfully recruited to participate in the study. It was assessed at the baseline survey, and the description says the study would assess the number of eligible women invited who enrolled and completed that survey. The outcome is therefore a recruitment and participation count, rather than a measure of symptoms, recurrence, or another clinical health outcome.

Recruitment is relevant to a pilot because it helps establish whether a study approach can reach and enroll the intended population. Completing the baseline survey also indicates participation through an early study activity. These are practical indicators of feasibility; they do not, by themselves, establish that a navigation tool changes care delivery or improves a patient’s health.

The endpoint description states an anticipated response rate of 80% enrollment (n=60). This is a stated expectation, not the observed endpoint value. Although the registry lists overall enrollment as 66, it does not report the primary outcome count in the results record. It also does not give arm-specific recruitment counts or the number completing the baseline survey. The numerical primary endpoint result is therefore not reported in the registry record, and a comparison between randomized groups cannot be interpreted from the endpoint entry alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is recorded as randomized and parallel-group. In general, randomization assigns participants to study groups using a chance-based process, with the aim of reducing systematic differences between groups at assignment. A parallel-group design follows separate groups receiving different assigned interventions. These design labels do not reveal the specific randomization sequence, allocation concealment method, or procedures used to maintain the assignment; those details are not reported in the registry record.

What does the primary outcome count?

The primary outcome is a count of patients successfully recruited to participate, with the description referring to eligible women invited, enrollment, and baseline-survey completion. A count answers how many participants met the specified endpoint definition. It should not automatically be interpreted as a rate, proportion, or between-group effect. A rate or proportion would require a clearly defined denominator and the relevant observed values; the registry record does not report arm-specific endpoint counts or denominator details for the primary result.

The record classifies the outcome as binary and describes its meaning as participants with an event (counts). Such a data label is not, on its own, a complete analysis method. It does not specify whether the outcome was modeled as a count, converted to a participant-level indicator, or analyzed in some other way. The registry lists zero analyses, so the statistical model and any analysis specifications are not reported in the registry record.

What can randomization tell us?

In general, randomization supports a fair comparison by making group assignment independent of participants’ measured and unmeasured characteristics on average. It does not guarantee that the groups will be identical, especially in a pilot study, and it does not replace reporting the observed outcomes. Interpretation also depends on how participants were analyzed, how missing observations were handled, and whether the analysis followed the original assignment. These details are not reported in the registry record.

How should uncertainty be read?

In general, an effect estimate describes the observed contrast between groups, while a confidence interval communicates uncertainty around that estimate. A p-value addresses how compatible the data are with a specified null model under the chosen analysis; it is not a measure of clinical importance or the probability that the null hypothesis is true. None of these numerical results for the primary outcome are reported in the registry record. No conclusion about effect size, statistical compatibility, or precision can be reconstructed from the enrollment figure alone.

For a count outcome, the appropriate analysis depends on how the endpoint is defined and on features of its distribution. In general, over-dispersion occurs when count variability exceeds what a simple count model assumes; ignoring it can make uncertainty estimates too small. This is a general methodological consideration only. The registry record does not report a model, a distributional assessment, or whether over-dispersion was considered, so it is not possible to say that any particular count method was used or needed in this trial.

What do the planning assumptions mean?

The planning illustration is described as using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It is based on a fraction of the observed effect. For this non-time-to-event setting, the description specifies participants per arm for the planning calculations. These are planning assumptions, not evidence about the study’s original sample-size rationale. The original sample-size justification is not reported in the registry record.

In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to detect an effect of a chosen size with a chosen level of power. A calculation based on an observed effect is retrospective and can be unstable, particularly when the observed effect is imprecise. Such illustrations should not be described as observed power: they do not measure the probability that the completed trial detected a true effect. The registry’s planning note expressly describes its figures as illustrations computed from the observed effect, not as the trial’s own design. No numerical planning results are stated in the registry record.

What does the masking label establish?

The registry identifies the study as triple-masked. In general, masking can reduce the influence of knowledge about assignment on participant reports, study procedures, or outcome assessment, depending on who is masked. The record does not say which parties were masked or how masking was implemented. It is therefore appropriate to report the registry’s label without inferring the identities of masked individuals or the practical success of masking.

Overall, the available methodological information defines the broad comparison and the intended primary measure, but not the analytic details needed to reproduce a statistical analysis. The registry record does not report an analysis plan, model specification, effect estimate, interval estimate, or test result for the primary endpoint.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Recruitment Population")
n      <- c(160)
events <- c(66)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Recruitment Population  160  66  41.2  33.5  49.3  33.9  49.0  33.9  49.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple outcomes: a primary recruitment measure and secondary measures concerning experience with the CCC care plan, provider preference, primary care appointment scheduling, coordination satisfaction, communication about provider roles, and knowledge of team-based survivorship care. When several outcomes are examined, the chance of obtaining at least one apparently notable result can increase. In general, a prespecified multiplicity strategy may address this issue through methods such as adjusting testing thresholds or defining a hierarchy of outcomes. The registry record does not report whether any such strategy was planned or used.

The record lists zero analyses. It does not report analysis populations, such as whether analyses were intended to include all randomized participants, participants who received an intervention, or only those with complete outcome data. The handling of missing baseline surveys, missing secondary outcomes, withdrawals, and deviations from assigned intervention is also not reported in the registry record.

These omissions matter because the estimated results can depend on which participants and observations are included and how missingness is handled. In general, an analysis restricted to participants with observed outcomes may differ from an analysis that accounts for all randomized participants, particularly if missingness is related to group assignment or outcome status. This is a general caution, not a statement about what happened in this trial.

Without a reported analysis plan and results, it is not possible to assess multiplicity control, missing-data assumptions, or whether the analyses followed an intention-to-treat principle. The registry record also does not explain how the secondary outcomes were measured or analyzed beyond their outcome titles.

12. 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 serious adverse event entries list 33 participants at risk in the control group and 33 in the CCC website group. The serious-event count is 0 in each group. The record also lists 0 deaths in each group. These figures are the registry’s recorded counts for the groups and should be read as such.

A zero count in these entries does not establish that no health events of any kind occurred. The record distinguishes serious events from other events and lists 0 participants with other events in each group as well. It does not provide event descriptions, follow-up details, or a fuller account of how adverse events were collected. No serious-event terms are listed.

In general, safety counts depend on the event definitions, observation period, completeness of reporting, and population included in the safety assessment. Those details are not reported in the registry record. The entries therefore support a narrow description of the posted serious-event and death counts; they do not support broader claims about all possible harms or the overall safety profile.

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

The record describes a randomized pilot comparison of a personalized survivorship-care navigation website with a static PDF care plan for women recently finished with primary breast cancer treatment. Its stated goals were to evaluate feasibility and acceptability and to explore whether the tool could improve delivery of team-based survivorship care. The primary outcome concerned recruitment and baseline-survey completion, while the listed secondary outcomes addressed experiences and aspects of continuing-care coordination.

What the registry record does not establish is whether the website improved any of those outcomes. It does not report the primary recruitment result, arm-specific outcome values, or numerical results for the secondary outcomes. No effect estimate or uncertainty interval is reported, and the record lists zero analyses. Overall enrollment of 66 is not itself a reported result for the primary endpoint, nor does it show whether participants completed the baseline survey or how enrollment differed between groups.

The anticipated response rate of 80% enrollment (n=60) is a planning expectation contained in the endpoint description. It must not be treated as the observed recruitment result. Similarly, the completed status indicates the trial is marked completed in the registry; it does not supply the missing outcome findings.

In general, a randomized design can support a comparison between assigned groups when outcomes and analyses are reported. It does not make conclusions possible in the absence of those results. The record therefore supports description of the trial question, interventions, broad design, enrollment listing, and posted safety counts. It does not support a conclusion that CCC did or did not change recruitment, acceptability, care coordination, or other patient-reported outcomes.

The trial’s pilot purpose also matters when interpreting its aims. Feasibility and acceptability questions concern whether an approach can be implemented and experienced by participants as intended. Those questions differ from proving a clinical benefit. The registry record names these aims, but does not report the measurements needed to judge them.

14. Why This Trial Matters Statistically

This trial raises statistical questions that are common in pilot studies of complex care interventions. The intervention was personalized and web-based, while the comparison was a static care-plan PDF. The main goals included feasibility and acceptability as well as exploration of care delivery. Those aims require clear outcome definitions and transparent reporting, because recruitment, user experience, and coordination are different constructs and may require different measures and analyses.

The registered primary outcome is a recruitment count tied to baseline-survey completion. That makes the distinction between a planned target and an observed result especially important. The outcome description states an anticipated response rate of 80% enrollment (n=60), and the registry lists enrollment of 66. Neither entry supplies the group-specific primary endpoint counts or confirms how many eligible invitees enrolled and completed the survey. A planned expectation and an overall enrollment figure cannot replace the endpoint results.

Randomized allocation can make the intervention comparison informative, but the value of that design depends on reporting what happened in each group and how those data were analyzed. The absence of posted analyses and outcome estimates prevents assessment of effect magnitude and precision. It also prevents evaluation of whether differences in experience, provider communication, appointment scheduling, or knowledge were observed.

For a pilot, the statistical contribution can include learning whether recruitment and measurement procedures are workable, not only estimating an intervention effect. However, those conclusions still require reported findings and definitions. The registry record identifies the questions of interest, but does not provide the numerical evidence needed to answer them.

15. 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 principal limitation for interpreting this trial from its registry record is that numerical primary and secondary outcome results are not reported. The primary endpoint is described, but its observed value and any group-specific results are absent. The record also lists zero analyses, leaving no reported effect estimates, uncertainty intervals, or statistical tests to evaluate.

Important design and analysis details are not reported in the registry record. These include the specific randomization procedure, the identities of those masked, the original sample-size justification, the analysis model, analysis populations, missing-data methods, and any multiplicity strategy. The record does not provide participant characteristics, details about adherence or engagement with the website, or further information about how the care-coordination outcomes were measured.

The registry lists enrollment as 66, while the primary endpoint description gives an anticipated response rate of 80% enrollment (n=60). The record does not give enough detail to reconcile those entries with the number of eligible women invited, enrolled, and completing the baseline survey. They should not be treated as interchangeable measures.

Safety information is also limited to the recorded group counts and does not describe event definitions, observation periods, or collection procedures. The listed zero counts should not be extended to unreported events or interpreted as a comprehensive safety assessment. These limitations restrict what can be concluded from the registry record; they do not establish what the full study report may contain.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The ConnectedCancerCare Pilot Study (CCC) — NCT03618017.
• Registry record last updated 2020-11-04; status last verified 2020-10.
• Results first posted 2020-11-04.
• 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.

19. Record Summary

The ConnectedCancerCare Pilot Study (CCC), NCT03618017, is listed as a completed randomized, parallel-group pilot trial with triple masking and enrollment of 66. It compared a personalized CCC website with a static survivorship care plan PDF for women who had recently completed primary breast cancer treatment.

The primary outcome was the number of patients successfully recruited to participate, assessed at the baseline survey. Its description states an anticipated response rate of 80% enrollment (n=60). The registry names secondary outcomes concerning care-plan experience, provider preferences, primary care appointments, care coordination, communication about provider roles, and knowledge of team-based survivorship care.

The registry record does not report numerical primary or secondary outcome findings and lists zero analyses. It records 0 serious adverse events and 0 deaths in each group, with 33 participants at risk in each. The study is marked completed, but its outcome effects and precision cannot be assessed from the posted registry results.