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 Positive Activities for Asian American Cancer Patients and Caregivers (NCT05203614), a randomized na study. The primary outcome is Affect-Adjective Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05203614 |
| Phase | NA |
| Condition | Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study title identifies Asian American cancer patients and caregivers. The registry record does not report detailed eligibility criteria, participant characteristics, or how many participants were patients versus caregivers.
Intervention
In the Household Contribution arm, participants were asked to do something thoughtful or nice for their caregiver that would provide tangible support. In the Outside Contribution arm, they were asked to do something outside their home or household that contributes to the larger society.
Comparator
The Control arm asked participants to keep track of their daily activities. The registry record does not report additional details about control procedures or whether the activity tracking involved other instructions.
Primary question
The primary outcome was positive and negative affect, measured with a modified Affect-Adjective Scale at end of study, identified as 4 weeks. The clinical question is whether affect was different across the activity assignments and control. However, the registry record does not report a single primary outcome comparison or numerical outcome results. It describes multiple outcome categories or time points without reducing them to one comparison, so the direction and precision of any between-group differences cannot be assessed from the registry record.
3. Trial Design
This was a randomized, parallel-group behavioral study sponsored by M.D. Anderson Cancer Center. The registry lists 60 participants enrolled and the study status as completed. The recorded start date is 2021-11-30, and the primary completion date is 2024-11-19. The phase is listed as NA.
Participants were assigned to Household Contribution, Outside Contribution, or Control. The registry describes the first two assignments as activities intended to contribute to a caregiver or to society beyond the household. The control assignment was to keep track of daily activities. Allocation is listed as randomized, and the model is parallel, meaning the study had separate groups assigned to different conditions rather than assigning every participant to each condition in sequence. The allocation ratio and randomization method are not reported in the registry record.
Masking is listed as none. The registry record therefore does not describe masking as part of the design. It does not report the intervention schedule, adherence procedures, or whether participants completed the assigned activities throughout the study. The primary outcome timeframe is end-of-study, identified as 4 weeks. The record lists five outcome measures and names Psychological Needs and Self-Perceived Burden as secondary outcomes, but it does not report a statistical analysis for them. Detailed demographic characteristics, group-specific baseline information, and the full analysis plan are not reported in 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: 8 participants were excluded from the study before assignment to groups. 3 were excluded due to caregivers not signing informated consent; 5 were excluded due to not completing baseline measures.
Overall Study
| Stage | Household Contribution | Outside Contribution | Control |
|---|---|---|---|
| STARTED | 15 | 19 | 14 |
| Patients | 10 | 12 | 10 |
| Caregivers | 5 | 7 | 4 |
| COMPLETED | 14 | 13 | 14 |
| NOT COMPLETED | 1 | 6 | 0 |
Reasons for not completing this period:
| Reason | Household Contribution | Outside Contribution | Control |
|---|---|---|---|
| Withdrawal by Subject | 1 | 4 | 0 |
| Lost to Follow-up | 0 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Only complete cases were analyzed (those who completed end-of-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 | Household Contribution | Outside Contribution | Control | Total |
|---|---|---|---|---|---|
| Participants analysed | 15 | 19 | 14 | 48 | |
| Age, Continuous: Patients | years | 53.0 (SD 14.87) | 55.8 (SD 12.76) | 55.10 (SD 12.26) | 53.65 (SD 12.35) |
| Age, Continuous: Caregivers | years | 57.0 (SD 11.49) | 48.0 (SD 9.47) | 51.00 (SD 13.93) | 53.65 (SD 12.35) |
| Sex: Female, Male: Patients – Female | Participants | 4 | 9 | 7 | 20 |
| Sex: Female, Male: Patients – Male | Participants | 6 | 3 | 3 | 12 |
| Sex: Female, Male: Caregivers – Female | Participants | 4 | 5 | 2 | 11 |
| Sex: Female, Male: Caregivers – Male | Participants | 1 | 2 | 2 | 5 |
| Race (NIH/OMB): Patients – American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Patients – Asian | Participants | 10 | 11 | 10 | 31 |
| Race (NIH/OMB): Patients – Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Patients – Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Patients – White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Patients – More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Patients – Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Asian | Participants | 5 | 7 | 4 | 16 |
| Race (NIH/OMB): Caregivers – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 15 | 19 | 14 | 48 |
6. Primary Endpoint
The registry lists the primary outcome as Affect-Adjective Scale, measured over End-of-study (4 weeks).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary measure was the modified 12-item Affect-Adjective Scale, described as assessing positive and negative affect. Participants rated the extent to which they experienced emotions over the past week, from 0, not at all, to 6, extremely. The scale included low-arousal emotion items, with peaceful or serene and dull or bored given as examples. The registry lists the outcome as a mean score with standard deviation at end of study, identified as 4 weeks.
Affect is a subjective dimension of emotional experience. Asking about several positive and negative emotion adjectives can describe more than one aspect of how participants felt over the past week, including emotions that are not necessarily highly activated. In general, a continuous score can be summarized by a mean to describe its central level and a standard deviation to describe how spread out individual scores are. Those summaries would help characterize responses in each group, but the registry record does not report the outcome values or a between-group estimate.
The record identifies the scale as modified but does not report how its items were combined into positive and negative scores, whether any items were reverse-coded, or how missing item responses were handled. Those details matter for interpreting what a particular score represents. The posted results do not provide enough information to assess the scale’s group-level results or the precision of a treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study is listed as completed, but the registry record does not report numerical results for the primary affect outcome. It gives no group means, standard deviations, between-group estimates, confidence intervals, or p-values. Consequently, the registry record does not establish the direction or size of any difference between Household Contribution, Outside Contribution, and Control, nor how precisely a difference was estimated. Absence of a reported comparison is not evidence that the groups had the same outcomes.
The primary outcome description includes positive and negative affect, while the registry also indicates that the outcome has multiple categories or time points and was not reduced to one comparison. Without category-specific results and a clearly identified contrast, a reader cannot tell which affect dimension or time point would be the basis for a single conclusion. The record does not explain whether the intended comparison was each activity assignment against control, a comparison between the two activity assignments, or another contrast.
The primary analysis population is described as complete cases: participants who completed the end-of-study assessment. The registry does not report the number of complete cases by group, how many enrolled participants lacked end-of-study measurements, or whether missingness differed across groups. Those omissions prevent assessment of how much information contributed to the outcome summaries and whether the analyzed participants may differ from those without end-of-study data.
Some adverse-event information is reported separately. The registry lists one participant affected by a serious adverse event in Outside Contribution and none in the other groups. It lists no deaths in any group. These counts concern safety reporting and do not supply evidence about the affect outcome or the comparative effect of the activities.
Overall, the registry record describes the study design and outcome measure but does not provide the outcome analysis needed to quantify a group difference. The results should therefore be read as unreported in the registry record rather than as positive, negative, or null. The study’s completed status and enrollment count do not substitute for outcome estimates and their uncertainty.
9. Statistical Methods Explained
The registry describes randomized allocation to three parallel groups. In general, randomization uses chance to assign participants and is intended to reduce systematic differences between groups at the start of a study. It does not guarantee that groups will be identical, especially in a study with a limited enrollment, and baseline characteristics are needed to judge how comparable the groups were in practice. Those characteristics and the specific randomization procedure are not reported in the registry record.
A parallel design means participants are assigned to one group and the groups are compared over the study period. Here, the assignments were Household Contribution, Outside Contribution, and Control. The registry lists no masking. In general, awareness of an assigned activity can affect participants’ expectations, engagement, or self-reported outcomes. The record does not describe additional steps to limit those influences, and it does not identify which parties, if any, were unaware of assignments.
The primary measure is continuous and is reported as a mean with standard deviation. In general, a mean describes the center of a set of scores, while a standard deviation describes their dispersion around that center. A group mean alone would not show how much individual responses vary. A comparison between group means would describe the estimated difference in average scores, but interpretation also depends on uncertainty and on how the comparison was specified. No mean, standard deviation, or comparison estimate for the primary outcome is reported in the registry record.
A confidence interval is a statistical range expressing uncertainty about an estimated quantity under the assumptions of the analysis. In general, a wider interval indicates less precision than a narrower interval, and an interval for a group difference can help readers judge which values are compatible with the data and model. The registry record does not report confidence intervals for the primary endpoint. A p-value, when reported, addresses compatibility of data with a specified null hypothesis under an analysis model; it does not describe the size or importance of an effect. No primary outcome p-value is reported.
The scale description includes positive and negative affect and several emotion adjectives. These categories should not be treated as interchangeable without knowing how the scores were constructed and analyzed. The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not report the separate estimates or the planned way to select or interpret them. This means the outcome’s structure cannot be reconstructed into a single statistical contrast from the registry record.
The sample-size planning illustration is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It is based on a stated fraction of the observed effect. These are planning assumptions for an illustration, not a report of the trial’s original design justification. The registry does not report the trial’s own sample-size justification, and the outcome estimate needed to interpret an illustration based on the observed effect is not reported with the primary outcome results. Any sample-size illustration is not observed power; it does not establish whether the completed study had sufficient precision or whether an effect was present.
In general, over-dispersion occurs when observed variation exceeds what a chosen statistical model expects. Accounting for it can matter when a model’s assumed variability is too small, because that can make uncertainty appear lower than it is. The registry record does not report a model for the primary outcome or indicate that over-dispersion was assessed; the endpoint is described as a continuous measure summarized by mean and standard deviation.
The record lists zero outcome analyses. It does not report the estimation method, covariate adjustment, handling of multiple comparisons, or a prespecified analysis plan. These details are important because different choices can change the estimate or its uncertainty. Without the analyses and results, statistical concepts can explain how a suitable comparison might be interpreted, but they cannot recover what the trial found.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, names Psychological Needs and Self-Perceived Burden as secondary outcomes, and describes positive and negative affect within the primary measure. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Examining multiple outcomes, categories, time points, or group contrasts creates multiplicity: in general, the chance of finding at least one apparently notable result can increase when many tests are considered. The registry record does not report whether any adjustment or other multiplicity strategy was planned.
The primary outcome population is restricted to complete cases, defined in the record as participants who completed the end-of-study assessment. The number of complete cases in each group and the reasons for missing end-of-study assessments are not reported in the registry record. The record does not describe imputation, sensitivity analyses, or another approach to missing outcome data. A complete-case analysis can be difficult to interpret if people with observed outcomes differ systematically from those without them; whether that concern applies cannot be assessed from the registry record.
The record does not report a detailed analysis population beyond the complete-case description for the primary endpoint. It also does not report whether all randomized participants were included in any other outcome analysis. The registry lists zero outcome analyses, so there are no reported estimates with which to assess the handling of missing data, multiplicity, or group comparisons. The analysis plan and any prespecified hierarchy among outcomes are not reported in the registry record.
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 |
|---|---|---|---|
| Household Contribution | 0 | 15 | 0.0% |
| Outside Contribution | 1 | 19 | 5.3% |
| Control | 0 | 14 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Household Contribution | 0 of 15 |
| Outside Contribution | 0 of 19 |
| Control | 0 of 14 |
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 |
|---|---|
| Household Contribution | 0 of 15 |
| Outside Contribution | 0 of 19 |
| Control | 0 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | Household Contribution | Outside Contribution | Control |
|---|---|---|---|---|
| Patient did not feel well enough to do study activities | General disorders | 0 of 15 | 1 of 19 | 0 of 14 |
Serious events with the highest arm-level rate: patient did not feel well enough to do study activities (5.3%).
The registry reports serious adverse-event information by group. In Household Contribution, 15 participants were at risk and 0 were affected by a serious adverse event. In Outside Contribution, 19 were at risk and 1 was affected. In Control, 14 were at risk and 0 were affected. The record lists 0 deaths in each group.
For other adverse events, the at-risk counts are 15 for Household Contribution, 19 for Outside Contribution, and 14 for Control; the number affected is 0 in each group. The registry also lists Patient did not feel well enough to do study activities as a top serious term, with 5.3%. The denominator and context for that percentage are not reported in the registry record, so it should not be converted into a count or treated as an arm-specific rate.
These figures are descriptive counts. They do not establish that an event was caused by an assigned activity, and the registry record does not report event timing, severity details beyond the serious classification, or a statistical comparison between groups. The small number of reported serious events also does not describe the affect outcome. No deaths are reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized study of two behavioral activity assignments and a daily-activity tracking control, with affect identified as the primary outcome. It reports that the study is completed and that 60 participants were enrolled. It does not report numerical results for the primary outcome or for the named secondary outcomes. Thus, the record does not allow readers to determine whether mean affect differed among the groups, in which direction any difference went, or how precise an estimate might be.
This absence should not be interpreted as showing that the assignments had no effect. A null finding would require reported estimates and uncertainty that are compatible with little or no difference; those results are not reported in the registry record. Conversely, the study’s rationale and intervention descriptions do not establish that an activity changed participants’ affect. Neither a favorable nor an unfavorable conclusion about the primary outcome can be drawn from the design description alone.
Even if outcome estimates were available, their interpretation would depend on the score construction, the comparison being made, the handling of multiple affect categories and time points, and the extent of missing end-of-study data. The record states that only complete cases were analyzed for the primary outcome but does not report their group counts or a missing-data analysis. These gaps limit assessment of both the magnitude and reliability of any estimated difference.
The serious adverse-event counts and absence of reported deaths are separate descriptive findings. They do not establish a comparative safety effect or resolve the missing primary outcome results. The registry record supports a description of the study’s design and reported safety counts, but not a conclusion about the effectiveness or lack of effectiveness of the activity assignments.
13. Why This Trial Matters Statistically
This study is statistically notable for using a self-reported affect measure in a randomized, three-group behavioral design. The groups represent two different kinds of contribution activity and a daily-activity tracking control, so interpretation depends on clearly identifying which groups are compared. The registry record does not report a single primary comparison, making it difficult to connect the outcome description to one estimand, meaning the precise effect the analysis is intended to estimate.
The affect outcome includes positive and negative dimensions and is assessed at end of study. Those dimensions may describe different experiences, and combining or selecting among them can affect what a result means. The record notes several categories or time points but does not provide the separate results or analysis plan. This illustrates why an outcome’s definition and comparison should be stated clearly before interpreting group differences.
Completeness is another important statistical issue. The primary analysis included only participants who completed the end-of-study assessment, but group-specific complete-case counts and missingness details are not reported. If missing outcomes are related to participants’ experiences or assigned activities, the analyzed groups may not represent everyone randomized. The registry record does not allow that possibility to be evaluated.
Finally, a completed study and an enrollment count are not substitutes for outcome estimates. Without reported means, contrasts, and measures of uncertainty, neither the size nor precision of an affect difference can be judged. The record therefore highlights how essential transparent outcome reporting is for interpreting a randomized trial.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific details needed for a fuller interpretation are not reported in the registry record. Eligibility criteria and participant characteristics are not specified, and the record does not distinguish how many participants were cancer patients and how many were caregivers. This limits assessment of who the findings might describe, even if outcome results were available.
The randomization method, allocation ratio, and allocation concealment are not reported. The record lists no masking but does not describe whether any procedures were used to reduce the influence of assignment awareness on self-reported affect. It also does not report intervention frequency, duration, adherence, or fidelity. The endpoint is timed at end of study, identified as 4 weeks, but additional follow-up is not reported in the registry record.
The primary measure is identified as a modified scale, but the scoring rules, handling of incomplete scale items, and separate results for positive and negative affect are not reported. The registry states that only complete cases were analyzed, without group-specific counts or missing-data sensitivity analyses. The analysis plan, outcome hierarchy, multiplicity handling, and adjustment strategy are also not reported. These limitations mean that neither the outcome definition nor the intended statistical comparison can be fully reconstructed from the registry record.
Most importantly, the registry record lists zero outcome analyses and does not report primary or secondary outcome estimates. Consequently, the design and safety information cannot answer the primary statistical question about group differences in affect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Positive Activities for Asian American Cancer Patients and Caregivers — NCT05203614.
- Registry record last updated 2026-08-13; status last verified 2026-08.
- Results first posted 2026-08-13.
- 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
NCT05203614, titled Positive Activities for Asian American Cancer Patients and Caregivers, is listed as a completed randomized, parallel-group behavioral study sponsored by M.D. Anderson Cancer Center. The registry reports 60 participants enrolled and identifies three assignments: Household Contribution, Outside Contribution, and Control, in which participants tracked daily activities.
The primary outcome was a modified Affect-Adjective Scale assessing positive and negative affect at end of study, identified as 4 weeks. Only participants who completed the end-of-study assessment were included in the primary analysis. The registry lists Psychological Needs and Self-Perceived Burden as secondary outcomes. It does not report outcome analyses or numerical results for the primary or secondary outcomes.
Serious adverse events were reported for 1 participant in Outside Contribution and 0 in each other group; the registry reports 0 deaths in all groups. The record does not provide a primary outcome comparison, confidence interval, or p-value.