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 Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers (NCT05200572), a na na study. The primary outcome is Proportion of Dyads That Complete the Study.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05200572 |
| Phase | NA |
| Condition | Cancer, Advanced, Cognitive Impairment, Mild |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 38 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Rochester |
| Results posted | Yes |
2. Clinical Question
Population
Older patients with advanced cancer and mild cognitive impairment, together with their caregivers, are the population identified by the study title and description. The intervention was intended for patient-caregiver pairs, called dyads. The record describes 19 dyads enrolled, comprising 38 participants.
Intervention
The intervention was a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy. The patient and caregiver went through the intervention together. The record describes 8 sessions.
Comparator
There was no separate comparator group. The study is listed as a single-group design, with allocation and masking recorded as NA and NONE, respectively. The registry record does not report a randomized or concurrent control comparison.
Primary question
The primary endpoint asks how many enrolled dyads completed the study procedures by week 14, expressed as a proportion of enrolled dyads. The registry record describes the denominator as 19 dyads but does not report the number that completed.
In statistical terms, this is a feasibility question: whether the study procedures were completed by enrolled pairs. It is not a comparison of DLR with another intervention or with usual care. Without a comparator, completion information can describe participation in this study, but it cannot estimate a difference in completion attributable to DLR relative to another approach.
The study description states that its purpose was to test the feasibility of delivering DLR to patients and caregivers. That purpose is distinct from testing a clinical effect. Although the record lists caregiver outcomes involving loneliness, relationship closeness, perceived stress, caregiver reactions, depressive symptoms, distress, dyadic adjustment, and dyadic support, the primary question is completion of study procedures. The record does not report the numerical results for those caregiver measures.
3. Trial Design
This completed study is registered as a single-group behavioral intervention study, with enrollment of 38 participants. The study describes participants as patient-caregiver dyads: 19 dyads, or 38 people, enrolled. Each pair was to undertake the Dyadic Life Review intervention together. The intervention is described as telehealth-based and adapted from individual Life Review Therapy; the record states that it consisted of 8 sessions.
The registry lists allocation as NA and masking as NONE. These entries are consistent with the stated single-group design: the record does not describe random assignment to intervention and control groups or masking. There is therefore no like-for-like control arm against which to estimate a comparative effect. The study cannot support the same interpretation as a randomized comparison, because no such comparison is described.
The recorded start date is 2022-03-28, the primary completion date is 2024-05-24, and the status is COMPLETED. The planned enrollment described in the brief summary was 20 dyads (40 total subjects); the primary endpoint description states that 19 dyads, or 38 participants, were enrolled. These are distinct planning and enrollment statements in the record.
The design is directed toward feasibility rather than a between-group efficacy estimate. The primary endpoint is the number of enrolled dyads completing study procedures by week 14, expressed relative to the enrolled dyads. The registry record does not report the completion count or proportion. It also does not report a statistical analysis plan, sample-size justification, interim analysis plan, or detailed analysis populations. Those omissions limit how fully the study's statistical design can be reconstructed from the registry record.
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: We approached 42 patients for consent. We enrolled 38 individual patients in the DLR Intervention study.
Overall Study
| Stage | DLR Intervention |
|---|---|
| STARTED | 38 |
| COMPLETED | 24 |
| NOT COMPLETED | 14 |
Reasons for not completing this period:
| Reason | DLR Intervention |
|---|---|
| Withdrawal by Subject | 14 |
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.
Population: Baseline data include both patients and caregivers (total N=38). Characteristics were not separated by participant role.
| Characteristic | Unit | Dyadic Life Review Intervention (Patients and Caregivers) |
|---|---|---|
| Participants analysed | 38 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 36 |
| Sex: Female, Male: Female | Participants | 22 |
| Sex: Female, Male: Male | Participants | 16 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 33 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 5 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 32 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 |
| Region of Enrollment: United States | participants | 38 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Dyads That Complete the Study, measured over week 14.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Dyads |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Proportion of Dyads That Complete the Study.” It measures completion of the entire study procedures by enrolled participants, with the dyad—the patient and caregiver pair—as the study unit. The stated assessment time is week 14. The endpoint description identifies 19 enrolled dyads, corresponding to 38 participants, and says the proportion was determined out of the 19 dyads enrolled.
Completion is useful in a feasibility study because it indicates whether enrolled pairs reach the end of the study procedures. It is a process measure, not a direct measure of symptom change, quality of life, or comparative treatment effect. A completion proportion can help characterize the practical conduct of the study, but it does not by itself establish why participants completed or did not complete, nor whether the intervention changed a clinical outcome.
The registry record does not report the number of dyads that completed the study. It therefore does not provide the observed numerator or the resulting proportion. The endpoint definition and denominator are described, but a numerical completion result cannot be interpreted from the record. No confidence interval or other measure of uncertainty for this endpoint is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical feature is the distinction between an endpoint definition and an endpoint result. The registry record defines completion as the primary outcome and identifies the enrolled denominator as 19 dyads. It does not state how many dyads completed the procedures by week 14. Consequently, the primary endpoint cannot be quantified from the registry information. Neither a completion proportion nor its precision can be assessed.
The enrollment information does establish that 19 dyads, or 38 participants, were enrolled. The brief summary had described a goal of 20 dyads (40 total subjects), while the endpoint description records the enrollment actually used in the primary denominator. A target and an enrolled total serve different purposes: the target is a planning statement, and enrollment describes who entered the study. Neither figure supplies the missing completion count.
The single-group design also determines what can be learned. With no comparator group, observations can describe the conduct of the intervention study, but they cannot distinguish intervention-related changes from other explanations for any observed change. The record lists caregiver measures as secondary outcomes, but their numerical results and analyses are not reported in the registry record. No claim about improvement, worsening, or comparative effect can be drawn from outcome names alone.
There are 19 outcome measures listed in the record and 0 analyses listed. The eight named caregiver outcomes concern loneliness, relationship closeness, perceived stress, caregiver reactions, geriatric depression, distress and problem-list responses, dyadic adjustment, and dyadic support. The record does not give their estimates, uncertainty intervals, or statistical tests. The fact that outcomes were registered is not evidence about their observed values.
The adverse-event record lists 38 people at risk and zero affected participants for both serious and other events, with zero deaths recorded. These are registry counts. They indicate what the record reports, not a guarantee that no event occurred outside the recorded definitions, observation period, or reporting process. The record does not describe event ascertainment details in the information available.
Overall, the information supports a description of the study's design, enrollment, endpoint definition, and recorded safety counts. It does not support a numerical conclusion about completion, caregiver outcome changes, or a clinical effect. The absence of reported estimates is an important limitation on interpretation, not a result demonstrating no effect.
9. Statistical Methods Explained
Statistical interpretation begins with the design. This study is registered as a single-group study, so it has no intervention-versus-control contrast. In a comparative trial, a difference between groups can be used to estimate how outcomes differ under the assigned study conditions, subject to the design and analysis assumptions. In a single-group study, there is no such comparison. Results can describe what happened among enrolled participants, but cannot isolate the intervention's effect from other influences.
What does the completion endpoint count?
The primary endpoint is a count-based completion measure expressed as a proportion of enrolled dyads. The unit is the dyad rather than an independent patient and caregiver outcome: the record describes each pair as completing the procedures together. The stated denominator is 19 enrolled dyads, and the assessment time is week 14. To interpret an observed proportion, a reader would need the number of those dyads that completed. That numerator is not reported in the registry record, so no proportion can be stated.
For a proportion, uncertainty matters as well as the point estimate. A confidence interval is a range calculated using a statistical method to express the uncertainty around an estimate. In general, it helps distinguish a precise estimate from one that remains compatible with a broad range of values. No completion estimate or confidence interval is reported in the registry record, so this uncertainty cannot be evaluated for the primary endpoint.
Why is a comparator important?
A control group provides a reference for interpreting outcomes over the same study context. Without one, a change from an earlier measurement to a later one, if reported, would not by itself show that the intervention caused the change. Changes may reflect other factors, including time, participant characteristics, measurement variation, or concurrent experiences. This is a general limitation of uncontrolled comparisons, not a claim that any particular alternative explanation occurred in this study.
The record lists allocation as NA and masking as NONE and identifies the model as single-group. There is no randomized allocation comparison to analyze. The registry record does not report a detailed statistical plan explaining how secondary measures were to be analyzed, how repeated measurements were handled, or how missing measurements were treated.
What does the sample-size planning language mean?
The registry's sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also describe an effect expressed as a stated fraction of the observed effect. For time-to-event tables, the assumptions refer to total events; for other tables, they refer to participants per arm. These are general planning conventions, not observed trial outcomes.
Those assumptions describe a hypothetical two-arm calculation, while this trial is registered as single-group. The record does not provide a numerical planning result in the information described, nor does it identify an observed effect estimate for such a calculation. The planning language should not be interpreted as evidence that this trial had two arms or as observed power. The record does not report the trial's own sample-size justification.
Power is a design quantity describing the chance that a specified analysis will detect an effect of a particular size under stated assumptions. It is not a measure of whether an observed finding is true, and it cannot be inferred from enrollment alone. A sample-size illustration based on hypothetical assumptions is not observed power. In this study, the primary endpoint is a completion proportion, and the registry information does not give the result needed to assess its estimate or precision.
How should the listed outcomes be understood?
The registry lists 19 outcome measures and 0 analyses. The listed secondary caregiver measures concern several different constructs, including loneliness, relationship closeness, perceived stress, caregiver reactions, depression, distress, dyadic adjustment, and dyadic support. Different outcomes may have different scales, time points, and directions of interpretation. The outcome names alone do not state the analysis method or the direction and size of any observed change. Numerical results are not reported in the registry record described.
General statistical interpretation also requires attention to the measurement scale, missing observations, and the analysis population. A count, a proportion, and a continuous questionnaire score do not have identical statistical properties. For count outcomes, over-dispersion can matter when variability exceeds what a simple count model assumes; this is a general issue, not a reported finding in this study. The registry does not report whether over-dispersion was assessed or whether any particular model was used.
Because the record does not report analysis details, it is not possible to determine whether analyses were descriptive or inferential, whether uncertainty intervals were calculated, or how multiple outcomes were handled. These are not assumptions that can be filled in from common practice. They remain unreported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 19 outcome measures, including the primary completion endpoint and secondary caregiver measures. It lists 0 analyses. The eight named secondary caregiver outcomes cover loneliness, relationship closeness, perceived stress, caregiver reactions, geriatric depression, distress and problem-list responses, dyadic adjustment, and dyadic support. The registry record does not report numerical results for these measures in the information described.
When a study assesses multiple outcomes, multiplicity is a general statistical concern: examining many outcomes can increase the chance that at least one appears noteworthy by chance. Statistical plans may address this through a prespecified hierarchy, adjustment, or interpretation emphasizing estimation and uncertainty. The registry record does not report whether any such approach was planned or used. No adjustment method should be assumed.
Missing-data handling is also not reported in the registry record. The endpoint description identifies the enrolled denominator, but does not state how incomplete procedures, withdrawal, or unavailable measurements were handled in analysis. For the primary endpoint, the completion numerator itself is not reported, so the proportion cannot be reconstructed. The record does not state whether missing secondary questionnaire measurements were excluded, imputed, or addressed in another way.
Analysis populations are not described in the registry record. It is therefore not possible to say which enrolled participants contributed to each outcome analysis or whether all enrolled dyads were included in every analysis. The record also does not report interim analyses or a detailed analysis plan. These gaps limit assessment of how outcome selection, incomplete data, and multiple measures may have shaped the reported findings.
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 |
|---|---|---|---|
| Cancer Patients and Caregivers (Dyadic Life Review Group) | 0 | 38 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cancer Patients and Caregivers (Dyadic Life Review Group) | 0 of 38 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cancer Patients and Caregivers (Dyadic Life Review Group) | 0 of 38 |
The safety record lists the Cancer Patients and Caregivers (Dyadic Life Review Group) as having 38 people at risk. It records zero affected for serious adverse events and zero affected for other adverse events; deaths are also recorded as zero. These figures are registry counts for the group described.
Zero recorded events should be read narrowly: the registry reports no affected participants in these categories. That is not the same as proving that no event occurred under any definition or circumstance. Interpretation depends on how events were defined, collected, and reported, and those details are not reported in the registry record described. The record also does not provide event-specific serious adverse event terms.
There is no comparison group, so these counts cannot be used to compare safety between DLR and another intervention. They also do not quantify the likelihood of events beyond the participants and reporting represented in the record. Safety counts describe recorded experience; they do not establish a general safety profile.
12. What the Result Does, and Does Not, Mean
The record establishes that a telehealth Dyadic Life Review study was completed as a single-group study, with 19 patient-caregiver dyads (38 participants) enrolled. It identifies completion of study procedures by week 14 as the primary endpoint and describes the intervention as 8 sessions undertaken by the dyad together. These details characterize the study and its feasibility focus.
The record does not report the number of dyads that completed the procedures. Therefore, it does not provide the central numerical result needed to assess the primary endpoint. Nor does it report the numerical results for the listed caregiver measures in the information described. No estimates of change, uncertainty intervals, or statistical test results can be interpreted from outcome titles alone.
The study's single-group design means that it does not estimate a comparative effect against a control condition. Even if an outcome change were reported, a change within participants would not alone show that DLR caused it. This design is appropriate to describe the study's stated feasibility aim, but it does not answer a randomized comparative question.
The recorded safety counts are zero affected participants for serious and other adverse events, and zero deaths among 38 people at risk. Those counts describe what the registry records and do not prove that no event occurred outside the recorded reporting. They also do not provide a comparison with another group.
In short, the registry information supports statements about design, enrollment, endpoint definition, and recorded adverse-event counts. It does not establish whether the dyads completed the study at a particular rate, whether caregiver outcomes changed, or whether the intervention had a clinical effect. A missing result should not be interpreted as a null result.
13. Why This Trial Matters Statistically
Feasibility studies address practical questions that can precede a larger or more comparative investigation. In this record, the central practical outcome is whether patient-caregiver dyads complete study procedures by week 14. Treating the dyad as the unit reflects the intervention's paired format: the patient and caregiver participate together. This makes clear why participant totals and dyad totals are not interchangeable descriptions of the study population.
The registry records 19 enrolled dyads and 38 participants, while the brief summary describes a target of 20 dyads (40 total subjects). Keeping planned and enrolled totals distinct is statistically important. A target describes the enrollment aim, whereas the enrolled total defines the study population available for outcome assessment. Neither figure substitutes for the unreported count of dyads that completed the procedures.
The single-group design also matters. It can document delivery and participation in the study as conducted, but it does not provide a control-based estimate of an intervention effect. Recognizing that distinction prevents descriptive feasibility information from being read as a causal or comparative result.
Finally, the record illustrates why endpoint definitions and outcome results must be read separately. A clearly described endpoint does not make its numerical value available when the result is absent. The 19 registered outcome measures and absence of listed analyses also make transparency about analysis choices important; multiplicity, missing data, and uncertainty cannot be assessed without those details. These are statistical interpretation issues, not evidence for or against the intervention.
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 most immediate limitation for interpretation is that the primary endpoint result is not reported in the registry record. The record defines completion and identifies 19 enrolled dyads as the denominator, but does not report the number completing. The primary feasibility outcome therefore cannot be quantified or assessed for precision.
The study is single-group, with no comparator. It can describe the enrolled dyads' experience as recorded, but cannot estimate a difference relative to another condition. This also limits causal interpretation of any within-participant outcome change. The registry record lists caregiver outcomes but does not give their numerical results in the information described.
The record states a target of 20 dyads (40 total subjects) in the brief summary and describes actual enrollment of 19 dyads (38 participants) for the primary endpoint. It does not report the sample-size justification or explain how the target was selected. It also does not report a detailed statistical analysis plan, missing-data method, analysis populations, interim analyses, or multiplicity approach.
The intervention description identifies telehealth DLR, dyadic participation, and 8 sessions, but the arm description is incomplete in the registry record. The record does not provide further delivery details in the information described. The scope of interpretation is also limited by the absence of numerical results for the secondary outcomes and by the limited event detail in the safety record. These limitations concern what can be concluded from the registry record, not necessarily what may have been documented elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers — NCT05200572.
- Registry record last updated 2025-11-25; status last verified 2025-11.
- Results first posted 2025-11-25.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05200572 is a completed, single-group behavioral study sponsored by the University of Rochester. It evaluated a telehealth Dyadic Life Review intervention adapted from individual Life Review Therapy for older patients with advanced cancer and their caregivers, including the study population described in relation to mild cognitive impairment. The intervention was undertaken by patient-caregiver pairs and consisted of 8 sessions.
The record lists enrollment of 38 participants, described for the primary endpoint as 19 dyads. The primary endpoint was the proportion of dyads completing the study procedures by week 14. The completion count and proportion are not reported in the registry record. The record lists 19 outcome measures and 0 analyses.
For the group of 38 participants at risk, the registry records zero serious adverse events, zero other adverse events, and zero deaths. The single-group design has no comparator, and the registry information described does not report numerical results for the caregiver outcomes or detailed analysis methods.