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 Outlook Quality of Life Intervention Study (NCT01044290), a randomized na study. The primary outcome is QUAL-E - Preparation Sub-scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01044290 |
| Phase | NA |
| Condition | Cancer, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 221 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
People with serious illness, including cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and end stage renal disease (ESRD). The registry record reports enrollment of 221, but does not give a more detailed description of participant eligibility or baseline characteristics in the information available for this analysis.
Intervention
The Outlook Intervention, also called Life Completion, was a psychosocial intervention involving meetings with a facilitator. The record describes three sessions lasting 45-60 minutes each. The first session included discussion of life review. The description of the subsequent session content is incomplete in the registry record, so the full intervention curriculum is not reported there.
Comparator
The registry lists an attention control in which participants met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD. It also lists treatment as usual, described as no intervention or attention control during the intervention window. The registry record does not identify one primary comparison among these groups.
Primary question
The study aimed to determine whether discussions concerning life story, forgiveness, and future goals improve quality of life for patients with serious illness. Its primary outcome was the QUAL-E Preparation Sub-scale, a measure of preparation for death. The registry record lists measurement at baseline, 5 weeks, and 7 weeks, but does not report outcome estimates or specify a primary time point and group contrast for the principal analysis.
3. Trial Design
The Outlook Quality of Life Intervention Study was a randomized, parallel-group trial sponsored by the VA Office of Research and Development. The registry classifies allocation as randomized and masking as single. It lists the study model as parallel and the status as completed. The phase is recorded as not applicable.
The registry record gives enrollment as 221. It lists people with cancer, congestive heart failure, chronic obstructive pulmonary disease, and end stage renal disease as the conditions of interest. More detailed eligibility criteria, recruitment procedures, and participant characteristics are not reported in the registry record available for this analysis.
The listed groups were Outlook Intervention, Attention Control, and Treatment as Usual. The intervention description specifies facilitator meetings and discussion activities, though its description is incomplete. The attention-control group met with a facilitator and listened to a non-guided relaxation CD. The treatment-as-usual group received neither the intervention nor attention control during the intervention window. The registry record does not report how randomization was generated, whether allocation was concealed, or which people were masked.
The study start is recorded as 2011-01, and primary completion as 2014-02. The record describes the primary outcome at baseline, 5 weeks, and 7 weeks. The corresponding reported sample sizes are baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60), and 7 weeks (n=64, 56, 64). The registry record does not identify the order of these samples by group in the outcome description. It also does not specify which follow-up time point or between-group contrast was designated as the primary test.
Six outcome measures and 12 analyses are recorded. The primary measure is the QUAL-E Preparation Sub-scale; listed secondary measures include POMS Anxiety Sub-scale, CES-D, FACIT-SP, and FACT-G - Social Sub-scale. The complete mapping between measures, analyses, groups, and time points is 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: Eligible participants were consented, screened with the Mini Mental Status Exam (MMSE), given a baseline interview, then randomized to group. Reasons for not randomizing participants included death, drop-out, unable to contact, and study removal due to non-eligibility.
Randomization
| Stage | Outlook Intervention | Attention Control | Arm 3 Treatment as Usual |
|---|---|---|---|
| STARTED | 75 | 74 | 72 |
| Randomized | 75 | 74 | 72 |
| COMPLETED | 75 | 74 | 72 |
| NOT COMPLETED | 0 | 0 | 0 |
Follow-up 1
| Stage | Outlook Intervention | Attention Control | Arm 3 Treatment as Usual |
|---|---|---|---|
| STARTED | 75 | 74 | 72 |
| Completed F1 Interview | 61 | 60 | 61 |
| COMPLETED | 70 | 69 | 71 |
| NOT COMPLETED | 5 | 5 | 1 |
Reasons for not completing this period:
| Reason | Outlook Intervention | Attention Control | Arm 3 Treatment as Usual |
|---|---|---|---|
| Death | 3 | 3 | 1 |
| Withdrawal by Subject | 2 | 2 | 0 |
Follow-Up 2
| Stage | Outlook Intervention | Attention Control | Arm 3 Treatment as Usual |
|---|---|---|---|
| STARTED | 70 | 69 | 71 |
| Completed F2 Interview | 64 | 57 | 64 |
| COMPLETED | 70 | 67 | 69 |
| NOT COMPLETED | 0 | 2 | 2 |
Reasons for not completing this period:
| Reason | Outlook Intervention | Attention Control | Arm 3 Treatment as Usual |
|---|---|---|---|
| Death | 0 | 1 | 1 |
| Withdrawal by Subject | 0 | 1 | 1 |
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: A total of 261 Durham VAMC patients with serious life-limiting disease were consented, and 221 were randomized to the study. Seventy-five were randomized to the Life completion intervention, 74 to the active control intervention, and 72 to the usual care control group.
| Characteristic | Unit | Arm 1 -Outlook Intervention | Arm 2 Attention Control | Arm 3 Treatment as Usual | Total |
|---|---|---|---|---|---|
| Participants analysed | 75 | 74 | 72 | 221 | |
| Age, Continuous | years | 68.7 (SD 9.4) | 68.2 (SD 9.8) | 66.4 (SD 8.3) | 67.8 (SD 9.2) |
| Sex: Female, Male: Female | Participants | 74 | 68 | 70 | 212 |
| Sex: Female, Male: Male | Participants | 1 | 6 | 2 | 9 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 2 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 75 | 73 | 70 | 218 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 38 | 31 | 28 | 97 |
| Race (NIH/OMB): White | Participants | 36 | 42 | 39 | 117 |
| Race (NIH/OMB): More than one race | Participants | 1 | 1 | 5 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 75 | 74 | 72 | 221 |
| Palliative Performance Scale - Stratification variable: High (greater or = 70) | participants | 55 | 55 | 54 | 164 |
| Palliative Performance Scale - Stratification variable: Low (less or = 60) | participants | 20 | 19 | 18 | 57 |
| Highest level of Education: Less than High School (HS) degree | participants | 6 | 7 | 8 | 21 |
| Highest level of Education: HS degree or GED | participants | 25 | 29 | 25 | 79 |
| Highest level of Education: Some college, associate, trade school | participants | 31 | 29 | 24 | 84 |
| Highest level of Education: Bachelor's degree | participants | 8 | 4 | 9 | 21 |
| Highest level of Education: some graduate/professional or higher degree | participants | 5 | 5 | 6 | 16 |
| Religion: Christian | participants | 72 | 69 | 62 | 203 |
| Religion: Other | participants | 1 | 1 | 3 | 5 |
| Religion: Not a member of a religion | participants | 2 | 3 | 5 | 10 |
| Religion: Missing | participants | 0 | 1 | 2 | 3 |
| Financial Status: Difficulty paying the bills | participants | 12 | 14 | 10 | 36 |
| Financial Status: Money to pay bills but need to cut back | participants | 20 | 19 | 19 | 58 |
| Financial Status: Pay bills but little spare money | participants | 25 | 25 | 22 | 72 |
| Financial Status: Have enough money for special things | participants | 18 | 16 | 21 | 55 |
| Working Status: Working for pay, part or full-time | participants | 4 | 7 | 4 | 15 |
| Working Status: Not working | participants | 4 | 6 | 9 | 19 |
| Working Status: Retired | participants | 44 | 41 | 41 | 126 |
| Working Status: Disability | participants | 23 | 20 | 18 | 61 |
6. Primary Endpoint
The registry lists the primary outcome as QUAL-E - Preparation Sub-scale, measured over Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is the QUAL-E Preparation Sub-scale, reported as a mean on a scale. The registry describes the Quality Of Life At The End Of Life measure (QUAL-E 2009) as a 31 item assessment of quality of life at the end of life, covering life completion, relationships with health care providers, preparation for death, physical symptoms, and affective social support. The primary outcome uses the 4-item preparation sub-scale.
Individual items use a 5 point Likert scale. The sub-scale minimum is 5 and the maximum is 20; higher scores indicate higher preparation. This endpoint focuses on one aspect of quality of life relevant to the study's stated purpose. It is not a direct measure of every domain included in QUAL-E, nor does the registry description make it a measure of the full experience of serious illness.
In general, a mean summarizes the average observed score in a group, while a standard deviation describes the spread of individual scores around that mean. The registry lists the dispersion measure as standard deviation and gives measurement points at baseline, 5 weeks, and 7 weeks. It does not report the group means, standard deviations, estimated between-group effects, or uncertainty intervals for this outcome. It also does not explain how the repeated measurements were used to define the primary analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question, design, primary outcome, and measurement schedule, but it does not include the numerical primary outcome results in the information available for this analysis. Group means, standard deviations, treatment contrasts, confidence intervals, and p-values are not reported in the registry record. Consequently, the size and precision of any difference in QUAL-E preparation scores cannot be described from these registry entries.
The record lists baseline, 5-week, and 7-week measurements, with sample sizes of baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60), and 7 weeks (n=64, 56, 64). It does not identify which numbers correspond to which groups in that outcome description. These figures indicate that the recorded outcome samples differ across measurement times, but do not by themselves explain why. Reasons for missing observations and methods used to address them are not reported in the registry record.
The registry indicates that the primary outcome has several categories or time points and is not reduced to one comparison. That matters for interpretation: an assessment of change over time, a comparison at a particular follow-up, and a comparison of change between groups answer different questions. The registry record does not specify which of these was the primary inferential target. It would therefore be inappropriate to select a time point or contrast and present it as the definitive primary result.
There are several listed groups, but a specific primary contrast is not reported in the registry record. The results therefore cannot establish whether the intervention group differed from attention control, treatment as usual, or both. Nor can a conclusion about statistical evidence be drawn without the outcome estimates and their uncertainty. General statistical principle: an estimate describes the direction and magnitude of an observed contrast, while its uncertainty interval indicates how precisely that contrast is estimated. Neither is available for the primary endpoint in this record.
The registry records six outcome measures and 12 analyses. The listed secondary measures include anxiety, depressive symptoms, spiritual well-being, and a social sub-scale of FACT-G. The result values for these outcomes are not reported in the registry record. Their listing alone does not establish that any outcome changed or differed between groups.
Accordingly, the defensible reading is limited to the trial's design and planned outcome structure. The registry describes a randomized study of a life-completion intervention and a preparation-focused quality-of-life measure, but the posted information does not permit an estimate of the intervention's observed effect or its precision.
9. Statistical Methods Explained
General statistical explanation: a randomized trial assigns participants to groups by chance, with the aim of making the groups comparable on average at the start of the study. Random allocation does not guarantee identical groups, and the credibility of the process also depends on details such as sequence generation and allocation concealment. The registry record says allocation was randomized but does not report those details.
What does a mean and standard deviation describe?
The primary outcome is continuous and is summarized as a mean with standard deviation. In general, the mean is the arithmetic average of the observed scores. The standard deviation describes how spread out those scores are around the mean. Neither statistic alone is a treatment effect: comparing groups requires a defined contrast, such as a difference in mean scores at a specified time point or a difference in change from baseline.
The registry record gives the QUAL-E Preparation Sub-scale range as 5 to 20, with higher values indicating higher preparation. The scale's bounded range is relevant when interpreting scores, because an average close to either endpoint leaves less room for movement in one direction. The registry record does not report the observed means or the distribution of scores, so their location within the scale cannot be assessed.
Why does the comparison need to be specified?
The study lists an Outlook intervention group, an attention-control group, and a treatment-as-usual group, and it reports repeated outcome time points. These design features permit more than one possible comparison, but the registry record does not identify a single primary contrast. A comparison with attention control addresses a different question from a comparison with treatment as usual. A comparison at follow-up also differs from an analysis of change from baseline.
General statistical explanation: when measurements are repeated on the same participants, those observations are related rather than independent. An analysis that accounts for this relationship can use the information across time while recognizing that each participant contributes multiple measurements. The particular model, covariance assumptions, and estimation method used in this study are not reported in the registry record. No method should be attributed to the investigators without that information.
How should uncertainty be understood?
General statistical explanation: an estimate is a numerical summary of an effect, and a confidence interval represents uncertainty around that estimate under the assumptions of the analysis. A narrower interval indicates greater precision; a wider interval indicates less precision. A p-value addresses compatibility between the observed data and a specified null hypothesis under a statistical model. It does not measure the size or practical importance of an effect.
The registry record does not report a primary effect estimate, confidence interval, or p-value. Thus, neither the direction nor the precision of the primary comparison can be evaluated. The record also does not report whether the analysis adjusted for baseline scores or other covariates.
What do the planning assumptions mean?
The registry's sample-size assumptions describe planning illustrations based on the observed effect, not the trial's own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of the observed effect. These assumptions describe how planning illustrations are framed, not the method used to analyze the trial. The registry record does not report the trial's own sample-size justification, and the illustration assumptions should not be treated as evidence of observed power.
General statistical explanation: a planning calculation estimates the sample size that might be needed under specified assumptions. Its result depends on the target effect, variability, significance level, allocation, and desired power. Such a calculation is not an observed property of a completed trial and cannot substitute for the confidence interval around an actual treatment estimate. The registry record's planning description does not report the numeric illustration results in the information available for this analysis.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when the observed variability in data is greater than a model assumes. If a model understates variability, its uncertainty estimates may be too small and its inferential results too confident. This concept is relevant to some count-data models, but the primary outcome is continuous and summarized as a mean with standard deviation. The registry record does not describe an analysis using a count-data model, so over-dispersion cannot be identified as an issue in the reported primary analysis.
The record lists six outcome measures and 12 analyses, but does not report the model specifications, test procedures, adjustment strategy, or analysis population. Those omissions limit reproducibility and make it impossible to assess whether the inferential methods matched the repeated-measures structure and the intended comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures and 12 analyses. It identifies QUAL-E Preparation Sub-scale as the primary outcome and names POMS Anxiety Sub-scale, CES-D, FACIT-SP, and FACT-G - Social Sub-scale among the secondary outcomes. A complete mapping of the analyses to outcomes, time points, and group contrasts is not reported in the registry record.
General statistical explanation: when several outcomes, time points, or comparisons are tested, the chance of at least one apparently unusual result can increase if each test is interpreted independently. A prespecified strategy may address this through a hierarchy of outcomes, adjustment, or a clearly defined primary comparison. The registry record does not report whether multiplicity was addressed, which tests were considered confirmatory, or whether any adjustment was applied. This absence does not establish that no plan existed; it means that the plan is not reported in the registry record.
The outcome description lists baseline, 5-week, and 7-week sample sizes as baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60), and 7 weeks (n=64, 56, 64). The record does not map these counts to the named groups in the outcome description or explain incomplete follow-up. It does not report missing-data assumptions, imputation, sensitivity analyses, or a method for handling participants with incomplete repeated measurements.
The analysis population is also not reported in the registry record. It is not stated whether analyses followed assigned groups, included only participants with observed outcomes, or used another population definition. Randomization and follow-up counts alone cannot establish which participants contributed to each estimate. Without the analysis population and missing-data methods, the risk that incomplete outcome data influenced estimates cannot be evaluated.
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 |
|---|---|---|---|
| Outlook Intervention | 12 | 75 | 16.0% |
| Attention Control | 16 | 74 | 21.6% |
| Treatment as Usual | 13 | 72 | 18.1% |
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 |
|---|---|
| Outlook Intervention | 6 of 75 |
| Attention Control | 8 of 74 |
| Treatment as Usual | 6 of 72 |
Most frequent serious adverse event terms
| Event term | Organ system | Outlook Intervention | Attention Control | Treatment as Usual |
|---|---|---|---|---|
| death | General disorders | 3 of 75 | 3 of 74 | 2 of 72 |
| neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 75 | 4 of 74 | 1 of 72 |
| general | General disorders | 1 of 75 | 3 of 74 | 1 of 72 |
| procedural complicaton | Surgical and medical procedures | 1 of 75 | 1 of 74 | 3 of 72 |
| respiratory | Respiratory, thoracic and mediastinal disorders | 0 of 75 | 2 of 74 | 3 of 72 |
| cardiac | Cardiac disorders | 3 of 75 | 0 of 74 | 1 of 72 |
| surgery | Surgical and medical procedures | 2 of 75 | 1 of 74 | 1 of 72 |
| psychiatric | Psychiatric disorders | 1 of 75 | 0 of 74 | 0 of 72 |
| skin | Skin and subcutaneous tissue disorders | 0 of 75 | 1 of 74 | 0 of 72 |
| renal | Renal and urinary disorders | 0 of 75 | 0 of 74 | 1 of 72 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Outlook Intervention | Attention Control | Treatment as Usual |
|---|---|---|---|---|
| psychiatric | Psychiatric disorders | 3 of 75 | 5 of 74 | 2 of 72 |
| infection | Infections and infestations | 3 of 75 | 3 of 74 | 4 of 72 |
Serious events with the highest arm-level rate: neoplasm (5.4%), procedural complicaton (4.2%), respiratory (4.2%), death (4.1%), general (4.1%).
The registry reports serious adverse event figures by listed group. For Outlook Intervention, the record gives 12 serious events among a risk set of 75; for Attention Control, 16 among 74; and for Treatment as Usual, 13 among 72. The corresponding other-adverse-event figures are 6 among 75, 8 among 74, and 6 among 72. These are registry counts, not evidence by themselves that the groups differ in safety.
The record does not give definitions of the reporting period, event coding rules, severity criteria, or whether the figures refer to participants with at least one event or event counts. Those details are not reported in the registry record. Deaths are recorded as null for each listed group, so a death count cannot be inferred from that field.
The registry also lists serious-event terms and percentages: neoplasm, 5.4%; procedural complication, 4.2%; respiratory, 4.2%; death, 4.1%; general, 4.1%; and cardiac, 4.0%. The denominators and relationship of these term percentages to the group-specific figures are not reported in the registry record. The appearance of a death term in this list does not resolve the null death fields. Comparisons of safety require consistent definitions, exposure and follow-up information, and appropriate uncertainty estimates; these are not reported.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized, parallel-group study of a psychosocial life-completion intervention for people with serious illness. Its stated purpose concerns quality of life, and its primary endpoint is a preparation-focused sub-scale of QUAL-E. The design information establishes what the study set out to investigate, but it does not supply the numerical primary outcome results needed to judge the observed differences.
The record does not report group means, standard deviations, treatment-effect estimates, confidence intervals, or p-values for the primary outcome. It also does not identify a single primary comparison or a primary time point among baseline, 5 weeks, and 7 weeks. Therefore, no conclusion about the direction, magnitude, or statistical precision of an effect can be drawn from the information recorded. The same limitation applies to the listed secondary outcomes, whose numerical results are not reported in the registry record.
General statistical explanation: statistical significance and clinical importance are different questions. A small effect can be estimated precisely, while a larger-looking estimate can remain uncertain when data are limited or variable. Interpreting either requires the effect estimate and its uncertainty, together with a clear account of the outcome and comparison. Those elements are absent for the primary outcome in this record.
The intervention's stated focus on life story, forgiveness, and future goals provides context for the question, but does not establish that those discussions changed preparation scores or broader quality of life. Likewise, the existence of attention-control and usual-care groups does not identify which comparison was intended to carry the primary inference.
The appropriate conclusion is therefore about the limits of the available registry information: it documents a completed randomized study and its outcome framework, but not enough outcome results or analysis details to determine what the trial found about its primary question. Missing results should not be interpreted as evidence of benefit, lack of benefit, or equivalence.
13. Why This Trial Matters Statistically
This study raises a statistical question that is common in clinical research: how should a multi-component, patient-focused intervention be evaluated when outcomes are measured repeatedly and compared across different control conditions? Its primary outcome is narrower than the broader quality-of-life purpose, focusing on preparation for death through the QUAL-E Preparation Sub-scale. A clear link between the stated question, chosen endpoint, time point, and primary contrast is important for interpretable results.
The registry records multiple outcomes and analyses, along with repeated measurements at baseline, 5 weeks, and 7 weeks. This structure makes transparent reporting of the analysis plan especially relevant. Readers need to know which outcome and comparison were primary, how repeated observations were handled, whether other tests were exploratory, and how incomplete follow-up was treated. Those details are not reported in the registry record.
The three listed groups also represent different comparators: facilitator contact and a relaxation CD in the attention-control group, versus no intervention or attention control during the intervention window in the treatment-as-usual group. A contrast against each comparator can address a different question. Identifying the intended primary contrast helps readers understand what any eventual estimate would mean.
Statistically, the registry record is a useful illustration of the difference between trial design information and result interpretation. Randomization, the outcome definition, and the measurement schedule establish context, but effect estimates and uncertainty are required to assess findings. In this case, the outcome estimates and key analysis details are not reported in the registry record, so the research question is documented without an interpretable numerical answer.
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 registry record available for this analysis has important limits for interpreting this specific trial. Although it identifies the primary outcome and its measurement schedule, it does not report the outcome means, standard deviations, between-group estimates, confidence intervals, or p-values. The primary comparison and primary time point are also not specified. These omissions prevent assessment of effect direction, size, and precision.
The intervention description is incomplete: it describes the first life-review session and mentions later sessions, but does not provide the full content of the subsequent sessions. The record therefore does not permit a complete account of what participants in the Outlook group received. Details about facilitator training, intervention fidelity, adherence, or variation in delivery are not reported in the registry record.
The description does not provide a detailed participant profile or eligibility criteria beyond listing the serious illnesses of interest. The outcome sample sizes are reported at baseline and follow-up, but are not mapped to groups in the outcome description. Reasons for missing observations and their handling are not reported. These limits make it difficult to evaluate representativeness, follow-up patterns, or the potential influence of missing data.
Random sequence generation, allocation concealment, the identity of masked parties, and the analysis population are not reported in the registry record. Nor are the statistical model, baseline adjustment, multiplicity strategy, or sample-size justification. The listed sample-size assumptions are planning illustrations and do not describe the trial's own design. Together, these gaps restrict independent assessment of the trial's methods and its reported safety and efficacy findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Outlook Quality of Life Intervention Study — NCT01044290.
- Registry record last updated 2015-11-20; status last verified 2015-10.
- Results first posted 2015-10-19.
- 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
The Outlook Quality of Life Intervention Study (NCT01044290) is recorded as a completed, randomized, parallel-group study sponsored by the VA Office of Research and Development. Enrollment is listed as 221, with study start in 2011-01 and primary completion in 2014-02. The conditions include cancer, congestive heart failure, chronic obstructive pulmonary disease, and end stage renal disease.
The registry lists Outlook Intervention, Attention Control, and Treatment as Usual. The primary outcome is the QUAL-E Preparation Sub-scale, measured at baseline, 5 weeks, and 7 weeks. Six outcome measures and 12 analyses are recorded. The registry record does not report the primary outcome estimates, uncertainty, a definitive primary comparison, or key analysis details. The record therefore documents the study framework but does not provide a numerical basis for interpreting its primary result.