CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology (NCT03302767), a na na study. The primary outcome is Quality of Life : EORTC QLQ-C30 Scores.

2. Clinical Question

In statistical terms, the central question is whether quality-of-life scores were assessed at the planned time points and how any change was estimated. A single-group design can describe participants’ scores over time, but it cannot by itself separate changes occurring during the study from changes that might have occurred for other reasons. The registry record does not provide the score estimates or an analysis comparing baseline with 5 months. It therefore does not establish the size, precision, or direction of any change in quality of life, nor does it establish how work status related to the scores.

3. Trial Design

CAP'Onco (NCT03302767) is recorded as a completed, single-group study sponsored by Institut Bergonié. The registry lists 29 participants enrolled. The study began on 2017-08-07, and primary completion was recorded on 2018-06-27. Phase is listed as NA, allocation as NA, and masking as none. The design has no randomized or parallel control group in the registry record.

The intervention is named Psychological and Social Consultation. Its description presents a coordinated support system with three axes: weekly multidisciplinary consultations involving a social worker and a psychologist or neuropsychologist; monthly information meetings and cognitive workshops; and an information booklet, “Prepare the work return.” These are components of the program description, not separately randomized interventions. The record does not report the extent to which each participant attended or received each component.

The primary outcome is EORTC QLQ-C30 quality-of-life scores, with measurement planned at baseline and 5 months. The registry describes standardised scoring according to the EORTC scoring manual and identifies 15 dimensions. Tiredness measured with Piper MFI-20 Scale Scores and anxio-depressive troubles measured with HAD Scale Scores are listed as secondary outcomes. The record lists 5 outcome measures overall, but detailed results for those measures are not reported in the registry record.

Although the study status is completed, completion status does not supply evidence about the outcome. The registry record lists no analyses, and it does not report numerical estimates, confidence intervals, or statistical tests for the primary endpoint. The protocol’s planned analysis methods, the definition of the analysis population, and any sample-size justification are not reported in the registry record. Because there is no control group, the design can describe observations among participants, but it cannot make a like-for-like comparison with people who did not receive the program.

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

Analysis population for the primary outcome, as defined in the registry: * At baseline, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients, 1 patient has missing data for the score 'Dyspnoea'. * At 5 months, 1 patient did not complete the QLQ-C30 questionnaire. And of the remaining 28 patients : * 1 patient has missing data for the scores 'Constipation' and 'Diarrhoea' * 1 another patient has missing data for the score 'Fatigue'

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Quality of Life : EORTC QLQ-C30 Scores, measured over At baseline and 5 months.

The primary endpoint is quality of life measured with EORTC QLQ-C30 scores at baseline and 5 months. The registry describes standardised scoring and identifies 15 dimensions, each on a scale from 0 to 100. It explains that score direction depends on the dimension: higher scores indicate better function or overall health and quality of life, but indicate more symptoms for symptom dimensions. Lower scores have the converse interpretation. Consequently, a score cannot be interpreted without knowing which dimension it represents.

Quality of life is relevant to the stated purpose because the program aims to support patients in regaining professional activity after treatment, and the research aims include evaluating quality-of-life improvement linked to work status. A multidimensional questionnaire can distinguish aspects of functioning, symptoms, and overall health rather than reducing the experience to a single undifferentiated measure. That makes the particular dimension and its scoring direction important when describing a result.

The endpoint is recorded as a mean with a 95% confidence interval. In general, a mean describes the average score in the assessed group, while a confidence interval conveys uncertainty around that estimate under the statistical method used. Neither quantity describes every participant’s experience. The registry record does not report the means or confidence intervals at either time point, nor does it report a numerical estimate of change between them. It is therefore not possible to describe the observed quality-of-life scores or their precision from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the mean describe?

The primary outcome is specified as a mean of a continuous measure. In general, a mean is the arithmetic average of the scores included in an analysis. It describes the center of the observed group’s scores, but it does not show how widely individual scores vary. Two groups or time points can have similar means while differing in the distribution of individual observations. For that reason, a mean is best interpreted alongside a measure of uncertainty and with attention to which participants contributed data.

The registry record names a 95% confidence interval as the measure of dispersion associated with the primary outcome. In general, a confidence interval expresses uncertainty in an estimated quantity under the assumptions of the analysis. It is not a range intended to contain most individual participants’ scores. Its width depends on the data and the method used. A narrow interval indicates greater precision for the estimated mean than a wide interval, but precision is distinct from whether a result is important to patients or meaningful in context. The registry record does not report the actual means or confidence intervals.

How should the questionnaire scores be read?

The EORTC QLQ-C30 is described as having 15 standardised dimensions, scored from 0 to 100. The registry gives dimension-dependent interpretation: high scores represent better functioning or overall health and quality of life, while high scores on symptom dimensions represent greater symptom burden. This means that a higher score does not have the same interpretation for every dimension. The dimension name and its scoring direction must accompany any numerical result. The record identifies Dyspnoea as one dimension for which a score was missing for a participant at baseline.

The endpoint is planned for baseline and 5 months. In general, repeated measurements on the same participants are related rather than independent. A method that estimates change should account for that relationship if it uses paired observations. A comparison of separate time-point means may answer a different statistical question from an analysis of within-participant change. The registry record does not specify which approach was planned or used, and it does not report a change estimate. The time points alone are not enough to determine the analysis method.

What does a single-group design allow?

A single-group study can describe outcomes among enrolled participants and, if the same people are measured repeatedly, can describe their observed trajectories. It does not create a concurrent counterfactual comparison: the registry record lists no control group against which to compare participants receiving the program. In general, a change over time may reflect the intervention, the natural course of health, other care, changes in work circumstances, or other influences. The design does not separate these explanations. No causal conclusion follows solely from a before-and-after difference.

Allocation is listed as NA and masking as none. There is no randomized allocation to a comparison arm described in the registry record. Masking concerns whether participants or study personnel are unaware of assigned interventions; in a single-group support program, the record’s “none” classification should not be taken to imply that outcome assessment was or was not blinded in any particular way. Further detail about outcome-assessor masking is not reported in the registry record.

Why do missing observations matter?

The registry reports incomplete QLQ-C30 information at both assessment times. In general, missing outcome data can affect which participants contribute to a mean and can reduce precision. If participants with missing questionnaires differ systematically from those with observed scores, the available scores may not represent the enrolled group in the same way. This is a general statistical concern, not a claim that such a difference occurred in this study.

At baseline, 1 patient did not complete the questionnaire, and among the other 28 patients, 1 had missing data for Dyspnoea. At 5 months, 1 patient did not complete the questionnaire, and among the other 28 patients, the record indicates another missing score but cuts off before naming the dimension. The registry record does not explain whether incomplete dimensions were excluded individually, whether any imputation was used, or whether a complete-case analysis was performed. It also does not describe sensitivity analyses for missing data.

What is known about the analysis plan?

The record lists no analyses and does not describe a statistical analysis plan. It does not report a planned model, a method for calculating confidence intervals, how the outcome dimensions were prioritized, or how the repeated assessments were handled. A sample-size justification and any interim analyses are not reported in the registry record. These details should not be inferred from the endpoint definition or the study’s completed status.

In general, a statistical analysis plan makes clear which outcomes and comparisons are primary, how missing values are treated, and how estimates and uncertainty are calculated. Reporting those decisions allows readers to judge whether the analysis matches the question and to understand the limits of the results. Here, the registry record specifies the primary measure, its time points, and the intended summary as a mean with a 95% confidence interval, but it does not report the estimates or explain the analysis that would produce them.

The registry also lists secondary outcomes for tiredness and anxio-depressive troubles. When multiple outcomes or dimensions are examined, there may be more opportunities for apparently notable findings by chance. In general, multiplicity refers to the consequences of drawing inferences across several outcomes or comparisons. The record does not report a multiplicity strategy, such as a prespecified hierarchy or adjustment. Without reported analyses, it is not possible to determine whether or how multiple outcomes were considered.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies a multidimensional primary questionnaire, listing 15 EORTC QLQ-C30 dimensions, as well as secondary outcomes for tiredness and anxio-depressive troubles. It does not report how the dimensions were prioritized for analysis or whether any approach to multiplicity was planned. In general, examining many outcomes or comparisons increases the chance that some estimates may appear notable even when findings are uncertain. A prespecified hierarchy or multiplicity adjustment can clarify how results across outcomes should be interpreted, but whether either was used is not reported in the registry record.

Missing questionnaire information is described at both planned primary assessment times. At baseline, 1 patient did not complete the QLQ-C30. Among the remaining 28 patients, 1 patient had missing data for the Dyspnoea score. At 5 months, 1 patient did not complete the questionnaire. Among the remaining 28 patients, the record states that 1 patient has missing data for a score but does not identify the score because the description is incomplete. The complete dimension-level missing-data account is not reported in the registry record.

The record does not explain how incomplete questionnaires or missing dimensions were handled, whether all available data were used, or which participants were included in each analysis. It also does not report an analysis population definition or sensitivity analyses. In general, these decisions matter because the participants included in a particular mean may differ across dimensions or time points, affecting both comparability and precision. The registry record does not provide enough information to determine how these issues were addressed.

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

The record describes the purpose and structure of a support program for people with cancer, identifies quality of life as the primary outcome, and gives the planned assessment times. It also reports enrollment and some details about incomplete questionnaires. It does not report primary or secondary outcome estimates, statistical tests, or confidence intervals. Accordingly, there is no reported numerical evidence in the registry record from which to describe whether quality-of-life scores changed or how precisely any change was estimated.

The stated aim includes quality-of-life improvement linked to work status, as well as utility, feasibility, and patient satisfaction. These are aims, not findings. The registry record does not report results that show whether participants returned to work, whether work status was associated with quality-of-life scores, or how participants rated the program. It does not provide enough information to draw conclusions about these outcomes.

Even if a baseline-to-follow-up change were reported, a single-group study would describe change among participants rather than provide a randomized comparison with an untreated or alternative-treatment group. In general, observed change over time does not by itself establish that the program caused the change. The registry record does not include a separate control arm, and no causal comparison is reported.

The record’s completed status means the study is registered as completed; it does not establish that the intervention achieved its aims. Likewise, the absence of reported results should not be interpreted as evidence that there was no change or no effect. It means that the registry information available for this account does not report the outcome findings needed to assess those questions. The appropriate interpretation is limited to the design, planned measures, enrollment, and the missing-data information that the record actually describes.

12. Why This Trial Matters Statistically

This study addresses a measurement and design question that is common in supportive-care research: how to describe patient-reported outcomes over time when an intervention is delivered to a single group. CAP'Onco focuses on quality of life in the context of support intended to help patients regain professional activity after treatment. Its registry description makes the intended connection between health-related quality of life and work status explicit, while the absence of a comparison group places clear limits on causal interpretation.

The primary measure is multidimensional, and its score direction varies by dimension. That feature matters statistically because interpreting a change requires knowing whether the dimension represents functioning, symptoms, or overall health and quality of life. A single broad statement that scores went up or down would not be sufficient to interpret every dimension. Missing dimension-level responses also mean that the analysis population could vary across scores, although the registry does not explain how those data were handled.

The record also illustrates the difference between a registered endpoint and a reported result. It gives a primary measure, time points, a mean and confidence-interval summary, and information about enrollment, but no outcome analyses or estimates. Readers therefore cannot evaluate effect size or precision from the registry information. This is not a finding of no effect; it is a limit on what can be concluded from the record.

For biostatisticians and clinical researchers, the study’s description underscores why reporting the analysis population, handling of missing data, and method for repeated measurements is important. Those details help readers understand what a mean represents and how much uncertainty surrounds it. With the registry’s analysis methods and results unreported, the design and reporting limitations remain central to statistical interpretation.

13. 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 main limitation for interpreting this study is that the registry record does not report outcome estimates or analyses. Although the record identifies EORTC QLQ-C30 scores as the primary outcome and gives baseline and 5-month time points, it supplies no means, confidence intervals, or change estimate. The listed secondary outcomes also have no reported results. Thus, the direction and precision of outcomes cannot be assessed from this record.

The single-group design has no concurrent control arm listed. Any descriptive change among participants, if reported elsewhere, would not by itself distinguish an intervention-related change from other changes over time. The registry does not describe a randomized comparison, and allocation is listed as NA. This limits the causal interpretation that could be supported by the design.

Enrollment was 29, but the registry does not report a sample-size justification or explain whether the enrolled group was sufficient for the intended analyses. It also does not report detailed eligibility criteria, cancer characteristics, treatment history, or participants’ work status at enrollment. These omissions limit assessment of how well the participants match the broader group addressed by the intervention’s stated purpose.

The missing-questionnaire description is incomplete. The record reports missing QLQ-C30 information at baseline and 5 months, but the 5-month description cuts off before identifying a missing dimension. It does not state how incomplete questionnaires were handled, define the analysis population, or report sensitivity analyses. Statistical methods for repeated measurements, confidence intervals, and multiple dimensions are also not reported in the registry record. These limitations prevent a detailed appraisal of the analysis and of the robustness of any results.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology — NCT03302767.
• Registry record last updated 2021-05-04; status last verified 2021-05.
• Results first posted 2021-05-04.
• 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.

17. Record Summary

CAP'Onco (NCT03302767), sponsored by Institut Bergonié, is recorded as completed, with 29 participants enrolled. The single-group intervention is Psychological and Social Consultation, a support program involving multidisciplinary consultations, information meetings and cognitive workshops, and an information booklet about preparing to return to work.

The primary outcome is EORTC QLQ-C30 quality-of-life scores at baseline and 5 months, reported as a mean with a 95% confidence interval in the planned measure. Piper MFI-20 tiredness scores and HAD anxio-depressive scores are listed as secondary outcomes. The record reports some missing QLQ-C30 information but gives an incomplete description of missing data at 5 months.

No analyses or outcome estimates are reported in the registry record. A sample-size justification, detailed analysis methods, and a control-group comparison are also not reported. The record therefore describes the study’s aim and design but does not establish the observed quality-of-life results or the effect of the program.