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 Building Resiliency Among Caregivers of Curvivors and Metavivors (NCT05702723), a randomized na study. The primary outcome is Proportion of Enrolled Participants (Feasibility).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05702723 |
| Phase | NA |
| Condition | Stress, Cancer Diagnosis, Distress, Emotional |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 94 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Massachusetts General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with cancer and their caregivers, enrolled and randomized together as survivor-caregiver dyads. Survivors were stratified by status: “curvivors,” defined as participants who had completed curative therapy, and “metavivors,” defined as participants with metastatic disease. The primary feasibility outcome description says that results are reported for individuals, counting survivors and caregivers separately.
Intervention
SMART-3RP is described as a virtual, mind-body group treatment program. The study’s stated purpose includes assessing its feasibility and participant satisfaction, as well as comparing it with referral to an online support group.
Comparator
The comparator is Enhanced Usual Care. Its arm description says participants were referred to a 14-week online support group. The record classifies both interventions as behavioral.
Primary question
The primary endpoint is a feasibility measure: the proportion of eligible participants who enroll. Its description specifies a feasibility cutoff of ≥ 45% enrollment of eligible dyads. The record also names retention and intervention-session completion as secondary feasibility outcomes, and describes resilience and distress as outcomes the study aimed to assess. Results for these outcomes are not reported in the registry record.
In statistical terms, the study asks whether recruitment and participation procedures can support a future evaluation, while also planning a randomized comparison of the intervention and comparator. The registry record does not provide a numerical primary-endpoint result or a comparative estimate for resilience or distress. It therefore does not establish whether the feasibility cutoff was reached or how outcomes differed between groups.
3. Trial Design
This is a completed, randomized, parallel-group pilot trial sponsored by Massachusetts General Hospital. The registry record lists an enrollment of 94. The study began on 2023-06-10, reached primary completion on 2024-10-01, and has a status of COMPLETED. Its phase is listed as NA. Masking is listed as NONE, so the design is recorded as unmasked.
Survivors and caregivers were randomized together as dyads, with stratification by survivor status: curvivor or metavivor. The arm descriptions state that randomization used a random plan generator and a 1:1 allocation. SMART-3RP was compared with Enhanced Usual Care, whose description specifies referral to a 14-week online support group. The SMART-3RP arm description is incomplete in the registry record, so further details of that arm’s procedures are not reported there.
The trial’s stated purpose emphasizes feasibility and participant satisfaction, alongside a comparison intended to examine resilience and distress. The registry record identifies the primary feasibility outcome as the proportion of eligible participants who enroll. It lists retention and intervention-session completion as secondary feasibility outcomes. There are four outcome measures in total, but the registry record does not report results for them.
The enrollment figure should not be mistaken for an outcome result or a count in each randomized arm. Arm-specific enrollment is not reported in the registry record. The record’s primary endpoint description separately states that 976 participants, or 488 caregiver-survivor dyads, were eligible. Those are eligibility counts, not the reported number enrolled in each arm. The record does not explain how the enrollment figure and eligible population were handled in the endpoint analysis.
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
| Stage | Smart-3RP | Enhanced Usual Care |
|---|---|---|
| STARTED | 48 | 46 |
| COMPLETED | 39 | 37 |
| NOT COMPLETED | 9 | 9 |
Analysis population for the primary outcome, as defined in the registry: Please note that data are reported here for individuals (including caregivers and survivors as individuals). A total of 976 participants (i.e., 488 caregiver+ survivor dyads) were eligible for the 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.
| Characteristic | Unit | Smart-3RP | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 48 | 46 | 94 | |
| Age, Continuous: Cancer survivor | Years | 62.9 (SD 11.3) | 61.4 (SD 13.6) | 62.2 (SD 12.4) |
| Age, Continuous: Caregiver | Years | 59.3 (SD 13.0) | 54.2 (SD 13.0) | 56.8 (SD 13.1) |
| Sex: Female, Male: Cancer Survivors – Female | Participants | 10 | 12 | 22 |
| Sex: Female, Male: Cancer Survivors – Male | Participants | 14 | 11 | 25 |
| Sex: Female, Male: Caregivers – Female | Participants | 14 | 17 | 31 |
| Sex: Female, Male: Caregivers – Male | Participants | 10 | 6 | 16 |
| Race (NIH/OMB): Cancer Survivors – American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Cancer Survivors – Asian | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): Cancer Survivors – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Cancer Survivors – Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Cancer Survivors – White | Participants | 19 | 20 | 39 |
| Race (NIH/OMB): Cancer Survivors – More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Cancer Survivors – Unknown or Not Reported | Participants | 3 | 0 | 3 |
| Race (NIH/OMB): Caregivers – American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Asian | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Caregivers – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Caregivers – White | Participants | 22 | 19 | 41 |
| Race (NIH/OMB): Caregivers – More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Cancer survivors – Hispanic or Latino | Participants | 2 | 5 | 7 |
| Ethnicity (NIH/OMB): Cancer survivors – Not Hispanic or Latino | Participants | 22 | 18 | 40 |
| Ethnicity (NIH/OMB): Cancer survivors – Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Caregivers – Hispanic or Latino | Participants | 3 | 4 | 7 |
| Ethnicity (NIH/OMB): Caregivers – Not Hispanic or Latino | Participants | 21 | 19 | 40 |
| Ethnicity (NIH/OMB): Caregivers – Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Enrollment Total: Cancer Survivors | Participants | 24 | 23 | 47 |
| Enrollment Total: Caregivers | Participants | 24 | 23 | 47 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Enrolled Participants (Feasibility), measured over At Screening.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Proportion of Enrolled Participants (Feasibility).” Its description defines it as the percent of survivors and caregivers, counted as individuals, who are eligible and enroll. It is measured at screening. The stated feasibility cutoff is ≥ 45% enrollment of eligible dyads, with an eligible dyad defined as a survivor and caregiver.
This endpoint addresses recruitment feasibility: whether eligible people can be enrolled under the study’s recruitment and screening procedures. Feasibility outcomes are useful in a pilot because they can indicate whether study processes are workable enough to inform later research. This is a general explanation of the role of feasibility endpoints, not a claim that this trial met its cutoff.
The endpoint description mixes an individual-level reporting unit with a dyad-level cutoff. The registry record says the data are reported for individuals, including survivors and caregivers as individuals, while defining the cutoff in terms of eligible dyads. The record does not explain how this difference in unit was addressed when assessing the cutoff. Nor does it report the observed enrollment proportion or state whether the cutoff was reached. The registry record therefore supports describing the intended measure and threshold, but not drawing a conclusion about the trial’s recruitment performance.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies this study as a pilot randomized comparison of SMART-3RP and Enhanced Usual Care. Its stated aims include feasibility, participant satisfaction, resilience, and distress. The available record does not report numerical outcome results or analyses for these aims. In particular, there is no posted value for the primary enrollment endpoint, the retention outcome, or intervention-session completion. There are also no reported estimates comparing resilience or distress between groups.
The record lists 94 participants enrolled and describes 976 eligible individuals, corresponding to 488 eligible dyads. These figures do not by themselves establish the primary endpoint result. The endpoint is described as the percent of eligible individuals who enroll, while the feasibility cutoff is defined for eligible dyads. Without a reported numerator, denominator used in the analysis, and endpoint estimate, the recruitment percentage cannot be determined from the registry record. No percentage should be inferred from the enrollment and eligibility counts.
The record lists four outcome measures and zero analyses. It also indicates that a primary outcome analysis was skipped because fewer than two arms were present in that outcome record. Whatever the reason for that entry, there is no reported arm-level primary outcome comparison to interpret. Consequently, the randomized design does not yield a posted estimate of treatment-group difference in the record.
The safety entries report zero serious adverse events and zero other adverse events in each of the four listed groups. Deaths are listed separately: one among SMART-3RP survivors, one among Enhanced Usual Care survivors, and zero in each caregiver group. These figures describe the registry’s safety entries; the record does not provide attribution, cause, timing, or a defined observation period for the deaths. The entries alone do not establish why deaths occurred or whether they were related to study participation.
Accordingly, the posted information permits a description of the design, feasibility questions, and recorded safety counts, but not an estimate of intervention effects, a conclusion about the feasibility threshold, or a precise assessment of outcome uncertainty. Absence of results in the registry record is not evidence that outcomes were unchanged or that no analyses were conducted outside that record. It means the corresponding estimates and methods are not reported in the registry record.
9. Statistical Methods Explained
The trial is registered as randomized, parallel-group, and unmasked. Randomization was conducted at the survivor-caregiver dyad level, with stratification by survivor status and a stated 1:1 allocation. This means the design assigned dyads to one of the two intervention groups rather than assigning survivors and caregivers independently. Stratification is a general design approach that can help ensure representation of prespecified participant categories across randomized groups; the record identifies the categories but does not report the resulting arm counts within each category.
What does randomization contribute?
In general, randomization aims to make comparison groups similar in expectation with respect to measured and unmeasured characteristics. That balance is a property of the assignment process, not a guarantee that groups will be identical in a pilot sample. Because survivors and caregivers were randomized together, outcomes for people within a dyad may also be related. The registry record does not describe whether or how that within-dyad relationship was handled in any outcome analysis. Since the record lists zero analyses, no analysis approach for such dependence is reported there.
What can be learned from the feasibility endpoint?
The primary endpoint concerns enrollment among eligible survivors and caregivers. As a general matter, a proportion summarizes the share of a defined eligible group that meets a specified event criterion—in this case, enrolling. Interpreting such a measure requires a clear numerator, denominator, and unit of analysis. The registry description refers to individuals for reporting, but defines the feasibility cutoff using eligible dyads. The record does not state how this difference was reconciled or provide the observed endpoint value. Thus, the stated cutoff can be described, but whether the criterion was met cannot be assessed.
Retention and intervention-session completion are listed as secondary feasibility outcomes. In general, retention concerns continued participation or follow-up, while session completion concerns participation in the intervention sessions. Their operational definitions, denominators, time points, and observed results are not reported in the registry record. The record also does not specify how participant satisfaction was measured, despite naming satisfaction as an aim.
How should the randomized comparison be read?
A comparative analysis would ordinarily estimate an outcome in each randomized group and quantify the difference between groups, with uncertainty represented by a confidence interval or other inferential measure. A confidence interval is a range of values compatible with the data and the chosen statistical procedure; it conveys precision as well as the direction and size of an estimated effect. This is general statistical context. The registry record does not provide group-specific outcome estimates, a treatment contrast, confidence intervals, or p-values for resilience, distress, or the feasibility outcomes. No numerical comparison can therefore be interpreted from the registry record.
The record’s indication that the primary outcome analysis was skipped because fewer than two arms were present means that a comparative result is not available in that outcome entry. The registered trial design itself names SMART-3RP and Enhanced Usual Care, but the outcome analysis record does not contain an analysis across those arms. The reason for the mismatch is not reported in the registry record.
What do the planning illustrations mean?
The stated sample-size assumptions describe planning illustrations computed from an observed effect, not the trial’s own design. They use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, such illustrations are expressed as participants per arm for a specified power, while time-to-event illustrations use a total event count. These are general descriptions of the stated assumptions, not evidence that the trial was designed with those sample sizes or that it had a particular probability of detecting an effect.
Sample-size calculations based on an observed effect are sensitive to the size and precision of that effect. In general, a planning illustration that uses an effect estimate from a pilot study should not be treated as a guarantee of future performance. It is not observed power, and it does not substitute for a protocol’s prospective sample-size justification. The registry record does not report the trial’s own sample-size justification, and it does not report an observed outcome effect from which a reader could evaluate the basis of an illustration.
Why can over-dispersion matter?
For count outcomes, a statistical model may assume a particular relationship between the mean and variability. Over-dispersion occurs when the observed variability exceeds what a model’s assumptions anticipate. In general, failing to account for it can make uncertainty estimates too small and statistical evidence appear more precise than warranted. This is general methodological context only: the primary endpoint is described as a feasibility proportion, the registry record identifies the outcome kind as binary with event counts, and no outcome analysis or model specification is reported. There is no basis in the registry record to say that an over-dispersion adjustment was needed or used.
Overall, the record contains enough design information to describe randomization, allocation, masking, and the intended feasibility questions. It does not contain the analysis methods or outcome estimates needed to assess statistical significance, precision, or group differences. Statistical interpretation should therefore remain limited to the design and the specific registered counts and definitions.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures, names the primary enrollment-feasibility outcome, and lists retention and intervention-session completion as secondary feasibility outcomes. It also states that the research aims include resilience and distress. The other outcome measures and their detailed definitions are not reported in the registry record. No statistical analyses are listed.
Multiplicity arises when several outcomes or comparisons are tested. In general, conducting many tests can increase the chance of at least one apparently notable result unless the analysis plan addresses this issue. The registry record does not describe a multiplicity strategy, a hierarchy among outcomes beyond the primary and secondary labels, or any adjustment to account for multiple testing. With no analyses or outcome results reported, it is not possible to assess how multiplicity affected the findings.
Missing-data procedures are also not reported in the registry record. The record does not state how missing screening, follow-up, retention, session-completion, resilience, or distress data were handled. It does not specify imputation, complete-case analysis, sensitivity analyses, or rules for incomplete dyads. Analysis populations—such as whether analyses were intended to follow randomized assignment or include only participants meeting a particular completion criterion—are not reported either.
The registry record’s statement that the primary outcome analysis was skipped because fewer than two arms were present leaves no comparative primary analysis to evaluate. It does not explain whether data were unavailable, whether the analysis was omitted for another reason, or what population would have been included. These unanswered questions limit interpretation and are not resolved by the overall enrollment figure.
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 |
|---|---|---|---|
| Smart-3RP Survivors | 0 | 24 | 0.0% |
| Enhanced Usual Care Survivors | 0 | 23 | 0.0% |
| SMART-3RP Caregivers | 0 | 24 | 0.0% |
| Enhanced Usual Care Caregivers | 0 | 23 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Smart-3RP Survivors | 1 of 24 |
| Enhanced Usual Care Survivors | 1 of 23 |
| SMART-3RP Caregivers | 0 of 24 |
| Enhanced Usual Care Caregivers | 0 of 23 |
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 |
|---|---|
| Smart-3RP Survivors | 0 of 24 |
| Enhanced Usual Care Survivors | 0 of 23 |
| SMART-3RP Caregivers | 0 of 24 |
| Enhanced Usual Care Caregivers | 0 of 23 |
The registry record lists four safety groups: SMART-3RP survivors, Enhanced Usual Care survivors, SMART-3RP caregivers, and Enhanced Usual Care caregivers. Serious adverse events are recorded as zero in each group, and other adverse events are also recorded as zero in each group. The number listed as at risk is 24 for each SMART-3RP group and 23 for each Enhanced Usual Care group.
Deaths appear as a separate count. The record lists one death among SMART-3RP survivors and one among Enhanced Usual Care survivors. It lists zero deaths among caregivers in both groups. Death counts should not be combined with serious or other adverse-event counts, because the record presents them separately. It does not report a cause, attribution to an intervention, timing, or the observation period covered by these entries.
These registry counts describe the reported safety entries, not a comparative risk estimate. The record gives no statistical comparison, uncertainty interval, or explanation of how adverse events were collected. Zero recorded events in a group does not prove that the underlying risk is zero; in general, event counts must be interpreted in light of the number observed and the duration and completeness of safety monitoring. Those monitoring details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed pilot used randomized assignment of survivor-caregiver dyads to SMART-3RP or Enhanced Usual Care, with stratification by survivor status. It also establishes that feasibility was central to the study’s stated purpose and that enrollment, retention, and intervention-session completion were registered as feasibility outcomes. The record provides an overall enrollment figure and describes the eligible population, but does not report the observed primary endpoint result.
Without the recruitment proportion and a clear account of its analysis unit, the record does not show whether the prespecified feasibility cutoff was attained. Without reported retention and session-completion outcomes, it also does not show how consistently participants remained involved or completed intervention sessions. Although resilience and distress are named as outcomes of interest, no group-specific results or comparisons are reported. There is consequently no basis in the registry record for saying that SMART-3RP changed those outcomes or differed from Enhanced Usual Care.
The safety entries report no serious or other adverse events in the listed groups, while separately recording deaths among survivors. Those entries do not identify causes or establish a relationship to treatment. They should be read as the counts recorded in the registry, not as a complete assessment of safety or a causal comparison.
More broadly, the design indicates that the study was structured to compare two groups, but the available outcome record does not report the estimates needed to quantify any difference or its precision. The absence of those results should not be interpreted as evidence of no effect, no feasibility, or no additional analyses outside the registry. It means that the registered record does not report the results needed to support those conclusions.
13. Why This Trial Matters Statistically
Pilot trials can be statistically important even when their main purpose is not to establish a definitive treatment effect. Their feasibility measures can identify whether recruitment, retention, and intervention delivery are sufficiently workable to inform later research. This trial explicitly places feasibility among its main aims and registers enrollment, retention, and session completion as relevant outcomes.
The study also uses a dyad-based design: a survivor and caregiver were randomized together, and survivor status was used for stratification. That structure matters for both design and analysis. In general, outcomes from members of the same dyad may be related, and methods should reflect the unit of randomization and any dependence in the data. The registry record does not report the analysis methods needed to assess whether this was addressed.
The distinction between individuals and dyads is especially relevant to the primary endpoint. The endpoint is described using individual-level reporting, but the cutoff is expressed in terms of eligible dyads. Clear reporting of the unit, denominator, and observed estimate is essential to judging whether a feasibility benchmark has been met. Those results and the explanation of the unit difference are not reported in the registry record.
Finally, statistical interpretation depends not only on trial design but also on outcome estimates, uncertainty, missing-data handling, and analysis choices. The registry record identifies a randomized comparison and reports safety counts, yet it lists no analyses and gives no efficacy or feasibility estimates. Recognizing that gap is important: a well-described research question and design do not by themselves establish what the data show.
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 largest limitation for statistical interpretation is that numerical results for the primary and secondary outcomes are not reported in the registry record. Although the record lists four outcome measures and states that the study is completed, it does not provide the enrollment proportion, retention result, session-completion result, satisfaction measure, or resilience and distress comparisons. The record lists zero analyses and indicates that the primary outcome analysis was skipped because fewer than two arms were present in that outcome entry.
The primary endpoint’s definition also leaves an interpretive issue: it describes individual-level reporting while defining its feasibility cutoff using dyads. The record does not explain how the eligible individuals and dyads were linked in the endpoint calculation. The reported enrollment and eligibility totals cannot resolve that issue without an endpoint numerator, denominator, and analysis rule.
Arm-specific enrollment and participant characteristics are not reported in the registry record. The intervention description for SMART-3RP is incomplete, and details about adherence, follow-up, outcome measurement, and the timing of non-primary assessments are not available. The record does not report a statistical analysis plan, sample-size justification, missing-data approach, multiplicity strategy, or analysis populations. These omissions prevent assessment of how the analyses were intended to address the trial’s design and multiple outcomes.
The safety record gives group counts but does not report the event observation period, attribution, causes of deaths, or the procedures used for safety monitoring. The counts therefore cannot support a detailed comparative safety assessment. These limitations concern what is reported in the registry record and do not establish what may be available in other study materials.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Building Resiliency Among Caregivers of Curvivors and Metavivors — NCT05702723.
- Registry record last updated 2026-04-13; status last verified 2026-01.
- Results first posted 2026-04-13.
- 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
NCT05702723 is a completed, randomized, parallel-group pilot trial sponsored by Massachusetts General Hospital. It enrolled 94 participants and compared SMART-3RP with Enhanced Usual Care. Survivor-caregiver dyads were randomized together, stratified by survivor status, with 1:1 allocation; masking is listed as none. Enhanced Usual Care included referral to a 14-week online support group.
The primary outcome concerns enrollment feasibility, with a stated cutoff of ≥ 45% enrollment of eligible dyads. Retention and intervention-session completion are listed as secondary feasibility outcomes. The registry record describes 976 eligible individuals, or 488 dyads, but does not report the primary outcome result or other outcome estimates. It lists zero analyses and reports no comparative results for resilience or distress.
Safety entries show zero serious and zero other adverse events in each listed group. Deaths are recorded separately: one in each survivor group and none in either caregiver group. The registry record does not provide attribution or observation-period details.