Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer (NCT05932810), a randomized na study. The primary outcome is Accrual.

2. Clinical Question

The trial also collected electronic questionnaire measures during participation, according to the study summary. The stated purpose was to evaluate a digital mental health approach for unmet psychosocial needs among people living with cancer. The registry record does not report results for depression symptoms or participant experiences as secondary outcomes. Consequently, the posted primary result addresses recruitment to the study rather than whether Moodivate changed depressed mood or how participants experienced the app.

3. Trial Design

This was a randomized, parallel-group study with no masking, listed as completed. The registry record gives an enrollment of 30 participants. The arms were Treatment as Usual, with 10 participants, and Moodivate, with 20 participants. The study summary describes an approximate allocation in which about two-thirds would receive the app and the remainder would not; the observed arm counts are consistent with that description.

The Moodivate arm was instructed to use the app regularly, at least once per day. The Treatment as Usual arm received educational material about mood management available through the EHR, with a suggestion to discuss questions with an oncology provider. Participants in both arms were asked to complete questionnaire measures weekly for 4 weeks, according to the arm description and study summary. The description of the Moodivate arm is incomplete in the registry record, so further details of its procedures are not reported in the registry record.

The primary outcome timeframe is described as the study duration, 6-7 months, or until recruitment is reached. The study summary separately describes participation as taking about 4 weeks. The record lists a start date of 2023-05-05 and primary completion on 2024-06-04. No phase is applicable as listed. The registry record does not report the randomization sequence method, allocation concealment, recruitment setting, or detailed eligibility criteria. These features limit how fully the trial conduct can be evaluated from the posted information.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

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 Accrual, measured over Study duration (6-7 months or until recruitment is reached).

The primary endpoint is titled “Accrual.” Its description defines the intended measure as the proportion of eligible people who enroll in the study. Accrual is a recruitment outcome: it concerns whether people who could participate enter the trial, rather than whether an intervention changes a clinical symptom. Recruitment outcomes can help assess whether a study approach is feasible and whether eligible people are willing to join.

The posted arm results are counts of participants: 10 in Treatment as Usual and 20 in Moodivate. These counts match the arm enrollment totals. The registry record does not report the number of eligible people who were approached, screened, or invited, or the number who declined. Without a reported denominator of eligible people, the proportion of eligible people who accrued cannot be independently evaluated from the posted counts alone. The outcome description also refers to “Illic eligible,” whose meaning is not clarified in the registry record.

The registry record therefore supports a description of enrollment by randomized group, but it does not supply the recruitment denominator needed to interpret accrual as a proportion of all eligible people. This distinction matters: the number enrolled describes the trial sample, while an accrual proportion requires a defined eligible population at risk of enrollment.

7. Results Posted in the Registry

• Moodivate: 100.0% (20/20) versus 100.0% (10/10) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization and the comparison. In a randomized trial, participants are assigned to study groups by a random process. Random assignment is intended to make groups comparable, on average, with respect to factors measured and not measured at baseline. This supports a fair comparison of outcomes when the study is conducted and analyzed as planned. The registry lists this study as randomized, with a parallel model and no masking. It does not report how the random sequence was generated, how assignments were concealed before enrollment, or whether any departures from assigned treatment occurred. Those details are not reported in the registry record, so the randomization process cannot be assessed in depth.

A parallel design assigns participants to one of the groups and follows the groups over the study period. Here, the groups were Moodivate and Treatment as Usual. The posted enrollment counts are 20 and 10, respectively. The study summary describes an intended approximate split of about two-thirds receiving the app and the remainder not receiving it. The record does not report why the final group sizes were as they were or whether the allocation ratio was specified in a protocol.

What does the risk difference represent?

A risk difference is a subtraction of the event proportions in two groups. It expresses the absolute difference in the probability of the defined event, on the scale used for that event. For an accrual comparison, its meaning depends on what counts as an event and who is included in the denominator. The registry reports a risk difference of 0.0 and arm-specific proportions of 1.0 for the posted comparison. However, the primary outcome description defines accrual in relation to eligible people, and the eligible denominator is not reported in the registry record. This leaves an important ambiguity about how the posted proportions relate to the intended endpoint.

How should the p-value be read?

A p-value describes how compatible the observed data are with a specified null model, under the assumptions of the statistical test. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. The posted comparison gives p = 1.0. The registry record does not report the statistical test, its assumptions, or an analysis plan, so the calculation cannot be independently assessed from the record. With a small enrollment and a result at the boundary of the reported proportions, the p-value should not be taken as proof that meaningful differences are absent.

The registry record lists zero analyses. Although a comparison estimate and p-value are posted, the analysis method and handling of the endpoint are not described. It is not reported in the registry record whether analyses were adjusted for other variables, whether any interim analyses were planned or conducted, or what statistical plan was prespecified. These details matter when evaluating how the result was selected and whether the reported comparison followed a plan set before data were examined.

What is the role of planning sample sizes?

Sample-size calculations are planning tools that estimate how many participants are needed to detect an effect under assumptions about the effect size, variability, significance level, allocation, and analysis. The planning illustration associated with this record is described as using the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning illustrations, not the trial’s own design justification and not observed power. The registry record does not report the trial’s sample-size justification. Because the posted comparison has a risk difference of 0.0, planning values based on fractions of that observed effect require especially cautious interpretation; the record does not provide a separate target effect for an independently designed study.

Observed power is not a useful substitute for interpreting the estimate and its uncertainty after a trial has been completed. The sample size reflects the number enrolled, while precision depends on the outcome and its distribution as well as the analysis method. The record does not report a statistical analysis plan, so it is not possible to determine what precision was anticipated or whether the primary analysis followed a prespecified method.

For outcomes based on counts or proportions, the definition of the event and the denominator are central. Here, enrollment counts are posted, but the endpoint description refers to eligible people and the eligible denominator is not posted. This limits what can be inferred from the reported proportions and comparison. The key statistical issue is not only the size of the estimate, but whether the estimate matches the intended endpoint and population.

10. Confidence Intervals and Precision

A confidence interval is a range of values compatible with the observed data under a specified statistical method and its assumptions. It describes uncertainty in an estimate; it does not mean that the true value has a particular probability of lying within the reported interval. Its width is affected by factors including the amount of information in the data, the outcome distribution, and the method used to calculate it.

The registry reports a risk difference of 0.0 with an interval from 0.0 to 0.0. This displayed interval has no width, so it communicates no uncertainty around the reported difference. That should not be interpreted as proof of perfect precision. The record does not report the confidence-interval method or explain how the endpoint denominators were defined. The posted proportions are at the boundary, and boundary results can make some interval methods behave differently from methods used for estimates away from the boundary. Without the method and denominators, the interval’s statistical properties cannot be evaluated from the registry record.

The enrollment is 30 participants, distributed as 10 in Treatment as Usual and 20 in Moodivate. Those counts are relevant context for precision, but they do not justify replacing the reported interval with a new calculation. In particular, the eligible denominator required by the endpoint description is not reported. A narrow or zero-width interval in a registry display cannot remedy a missing endpoint definition or denominator.

The comparison should therefore be read as a posted estimate with a reported interval, while recognizing that the available information does not establish how that interval was constructed. The result cannot be taken as evidence that small differences are excluded. A meaningful assessment of precision would require a clearly defined outcome, its denominator, and the analysis method, none of which is fully documented for this comparison in the registry record.

11. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study tests or reports multiple outcomes, comparisons, time points, or subgroups. As the number of analyses increases, the chance of obtaining a small p-value by chance can also increase. Statistical plans often address this by specifying a primary outcome, defining other analyses, and describing any adjustment or hierarchy for interpreting multiple tests.

The registry lists one outcome measure, identifies Accrual as the primary outcome, and reports zero analyses. The study summary says questionnaires assessed depression symptoms and participants’ experiences using Moodivate and participating in the trial, but results for those measures are not reported in the registry record. The record does not report whether multiple time points, subgroup analyses, or adjustments for multiplicity were planned. It is therefore not possible to determine how the posted comparison fits into a broader analysis plan or whether unposted analyses were conducted.

Missing data can affect an estimate if outcome information is unavailable for some participants, especially when missingness is related to group assignment or outcome values. The study summary describes questionnaires throughout the study, but the registry record does not report questionnaire completion, missing outcome counts, reasons for missingness, or methods for handling missing data. It also does not describe a participant flow from screening through enrollment and outcome assessment. No assumptions about complete follow-up or the treatment of missing values can be made from the posted information.

The record does not specify whether the analysis included all randomized participants, only participants with observed outcomes, or another analysis population. It does not report how participants who stopped using the app, did not follow the instructions, or had incomplete questionnaires were handled. These analysis-population definitions are important for interpreting a randomized comparison, but they are not reported in the registry record. The reported result should be understood as the posted comparison without assuming an intention-to-treat approach, a per-protocol approach, or any particular missing-data strategy.

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 registry reports zero serious adverse events and zero deaths in both groups: Treatment as Usual had 0 serious events among 10 participants at risk, and Moodivate had 0 among 20 at risk. It also reports zero other adverse events in each group, among the same numbers at risk. No serious adverse event terms are listed.

These are counts reported for the trial, not evidence that no adverse events could occur. With a limited number of participants, zero observed events does not establish that the underlying risk is zero. The registry record does not report the adverse-event collection period, definitions used for serious or other events, ascertainment procedures, or whether all participants were monitored for the same duration. The study summary identifies possible risks including frustration, worsening emotional distress, data breach, and loss of confidentiality, but it does not report observed events of these kinds.

The safety figures should be read as an account of events recorded in the registry, within an incompletely described assessment process. They do not support a broad comparison of safety between the app and treatment as usual or predictions about risk beyond the participants and observation recorded.

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

The posted data establish that the completed study enrolled 30 participants, with 10 assigned to Treatment as Usual and 20 assigned to Moodivate. The primary outcome is labeled Accrual, and the registry reports a risk difference of 0.0, an interval from 0.0 to 0.0, and p = 1.0 for the comparison. These statements describe the registry result; they should not be expanded into claims about depression symptoms or the effectiveness of the app.

The study’s stated purpose was to evaluate Moodivate among cancer survivors, and the summary describes questionnaires on depression symptoms and participant experiences. However, those results are not reported in the registry record. There is no posted primary comparison of symptom change, and the record does not report engagement results or results about the experience of participating. The accrual outcome is distinct from a clinical outcome: it concerns recruitment rather than whether depressed mood changed.

The endpoint description refers to a proportion of eligible people who accrued, but the eligible denominator and details of screening and recruitment are not reported. This prevents a complete interpretation of the accrual measure as a recruitment rate. The zero-width interval also does not establish perfect precision; the method and denominator are not explained in the record. The posted p-value does not show that two approaches are equivalent, and the record does not describe an equivalence analysis or margin.

Accordingly, the result supports a limited account of trial enrollment and the posted comparison. It does not establish that Moodivate did or did not improve depression symptoms, that the approaches produce identical outcomes, or that recruitment would be similar in a different population or setting. Those conclusions would require clearly defined clinical outcomes and analyses, together with details about eligibility, follow-up, and the statistical methods. Such information is not reported in the registry record.

14. Why This Trial Matters Statistically

Statistically, the key feature of this study is the distinction between a recruitment endpoint and a treatment outcome. Accrual can be useful when investigators need to understand whether eligible people enter a study. It answers a different question from whether an intervention changes symptoms. The study’s stated interest in a digital mental health approach may draw attention to depression, but the posted primary endpoint is accrual, and no depression-symptom results are reported in the registry record.

The record also illustrates why endpoint definitions and denominators matter. A count of enrolled participants is directly interpretable as the size of the enrolled sample. A proportion of eligible people who accrue requires a clear account of who was eligible and how many were approached or invited. Those denominators are not reported, leaving the intended recruitment measure difficult to assess. Likewise, a reported zero-width interval does not automatically mean the result is known without uncertainty; its calculation and underlying denominator require explanation.

These distinctions matter to clinical researchers designing and interpreting feasibility studies. Recruitment counts, feasibility outcomes, participant-reported outcomes, and clinical outcomes should not be treated as interchangeable. A registry entry can communicate an important study question, but complete interpretation also depends on transparent reporting of the analysis population, missing data, outcome definitions, and statistical methods. In this record, several of those details are not reported, so the scope of what the posted results can support is narrow.

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 primary outcome description contains the phrase “Illic eligible,” which is not clarified in the registry record. It also defines accrual as a proportion of eligible people, while the posted arm results are counts matching the randomized group sizes. The record does not report the eligible denominator, numbers screened or approached, or recruitment decisions. This makes it difficult to connect the stated endpoint definition to the posted comparison.

Important design and analysis details are not reported in the registry record. These include the randomization method and concealment, full eligibility criteria, the statistical analysis plan, the test used for the posted comparison, the confidence-interval method, and the sample-size justification. The record also does not report whether interim analyses were planned or conducted. The displayed interval from 0.0 to 0.0 therefore cannot be evaluated independently as a measure of precision.

The registry lists one outcome measure and zero analyses, while the study summary describes depression and experience questionnaires. Results for those measures are not reported in the registry record. Missing outcome counts, reasons for missingness, participant flow, adherence, and the analysis population are also not reported. These omissions prevent assessment of whether all randomized participants contributed to the posted comparison and how incomplete questionnaires were handled.

Safety reporting is limited to the posted counts. The observation period and event-collection procedures are not reported in the registry record. The Moodivate arm description is incomplete, and the record does not explain the rationale for the final group sizes or provide additional information about implementation. Taken together, these limits restrict interpretation to the enrollment counts, the posted accrual comparison, and the adverse-event counts as recorded.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Cancer — NCT05932810.
• Registry record last updated 2025-04-01; status last verified 2025-03.
• Results first posted 2025-04-01.
• 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

NCT05932810 is a completed randomized, parallel-group study with no masking, sponsored by the Medical University of South Carolina. It enrolled 30 participants: 20 in Moodivate and 10 in Treatment as Usual. The study summary describes a 4-week participation period and questionnaire measures. The primary outcome is Accrual, described as the proportion of eligible people who enroll.

The posted comparison reports a risk difference of 0.0, an interval from 0.0 to 0.0, and p = 1.0. The registry record does not report the eligible denominator, depression-symptom results, or the statistical analysis methods needed to assess the comparison fully. Serious adverse events, other adverse events, and deaths are reported as zero in both groups. These findings are limited to the outcomes and counts recorded in the registry.