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 Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté) (NCT03359759), a registered phase not stated study. The primary outcome is Quality of Life of the Patients at 12 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03359759 |
| Phase | Phase not stated |
| Condition | Breast Cancer |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Institut Bergonié |
| Results posted | Yes |
2. Clinical Question
Population
Patients treated for metastatic breast cancer who live far from their comprehensive cancer center. The primary-outcome population is narrower: patients alive, not lost to follow-up, and with a completed questionnaire at the assessment time.
Intervention
The study concerns follow-up using telemedicine, connected watches, and patient-reported symptom monitoring. The intervention entry in the registry record is “Conected objects.”
Comparator
A comparator group is not described. The record does not state an allocation method, and the study is identified as observational rather than a randomized comparison.
Primary question
What is the quality-of-life score on the FACT-B questionnaire at 12 months among patients who are alive, not lost to follow-up, and have completed the questionnaire?
The registry frames e-DomSanté around the use of remote follow-up technologies in cancer care. Its brief summary describes patients with metastatic breast cancer who live far from their comprehensive cancer center and are followed with telemedicine, connected watches, and patient-reported symptom monitoring. The stated primary outcome is quality of life, measured with the FACT-B questionnaire at 12 months.
The record does not set out a treatment-versus-control question. It does not state that patients were assigned to a technology group and a comparison group, nor does it describe a like-for-like control condition. Accordingly, the primary question is descriptive: what score was recorded in the specified outcome population? It is not a question about a randomized difference or a causal effect.
The registry lists enrollment of 15. It does not report how many of those participants were alive, remained in follow-up, and completed the questionnaire at the assessment time. That distinction matters because the primary outcome population excludes people who do not meet those criteria. The number of eligible completed questionnaires and the observed score are not reported in the registry record.
3. Trial Design
e-DomSanté is registered as an observational study, with the study kind classified as “other” and its status listed as completed. Institut Bergonié is the named sponsor. The record gives a start of 2016-01 and a primary completion of 2016-12, and lists enrollment of 15.
The clinical setting described in the brief summary is follow-up for patients treated for metastatic breast cancer who live far from their comprehensive cancer center. The follow-up approach involves telemedicine, connected watches, and monitoring of patient-reported symptoms. The registry’s intervention entry is “Conected objects,” classified as “other.” The record does not specify the technology components, their use schedule, or how the follow-up process was delivered.
No allocation method is stated, and the registry does not describe randomized assignment. It also does not define a control arm or a comparison condition. The assumptions used for a sample-size planning illustration mention equal allocation between two arms, but those assumptions do not establish that the observational study itself had two arms. The record does not report group-level enrollment or participant assignment.
The primary outcome is quality of life measured with the FACT-B questionnaire at 12 months. The planned summary is a median with a full range, for patients alive, not lost to follow-up, and with a completed questionnaire. The registry lists two outcome measures, but a second outcome’s details are not included in the record summarized for this analysis.
Although the study is marked completed, completion status is not the same as a posted report of outcomes. The number of analyses is listed as zero, and no primary-outcome result is reported in the registry record. Further details about the protocol, recruitment process, follow-up procedures, sample-size justification, or statistical 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.
Overall Study
| Stage | Patients With Advanced Disease |
|---|---|
| STARTED | 15 |
| COMPLETED | 10 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Patients With Advanced Disease |
|---|---|
| Death | 3 |
| Lost to Follow-up | 2 |
Analysis population for the primary outcome, as defined in the registry: Patients alive, not lost to follow-up, and with a completed questionnaire
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 | Patients With Advanced Disease |
|---|---|---|
| Participants analysed | 15 | |
| Age, Continuous | years | 65 (36 to 82) |
| Sex: Female, Male: Female | Participants | 15 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: France | participants | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Quality of Life of the Patients at 12 Months, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is quality of life at 12 months, assessed with the FACT-B questionnaire. The registry describes FACT-B as a validated quality-of-life instrument used primarily with breast cancer patients in clinical and research settings. Its total score ranges from 0-148, with a higher score indicating better quality of life.
Quality of life captures a patient-reported dimension of health and experience that is not represented by a clinical event count alone. In a study involving remote follow-up and symptom monitoring, a questionnaire score can describe participants’ reported status at the specified assessment time. That is the general role of a patient-reported outcome; it does not by itself establish that a particular follow-up approach caused a score to change.
The registry specifies a median and full range as the summary for the endpoint. A median describes the middle of the observed score distribution, while the full range identifies its lowest and highest observed values. These descriptive statistics can communicate the central score and the spread across the observed participants, but they do not alone quantify uncertainty about a group difference or establish a causal effect.
The endpoint population includes only patients who are alive, not lost to follow-up, and have completed the questionnaire. The record does not report how many participants met these conditions or the resulting FACT-B scores. It therefore does not provide a numerical description of quality of life at the assessment time.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes an observational study with enrollment of 15 and a primary quality-of-life assessment at 12 months. It identifies FACT-B as the measurement instrument and specifies that the planned summary is a median and full range. These details define what the primary outcome was intended to measure, but they do not supply an observed outcome.
No median, range, or other FACT-B result is reported in the registry record. The number of analyses is listed as zero. Consequently, the registry does not allow a reader to describe the observed quality-of-life score, its variation among participants, or the precision of an estimated score. There is also no reported comparison estimate or confidence interval to interpret.
The outcome population is conditional on being alive, not lost to follow-up, and having completed the questionnaire. The number meeting those conditions is not reported. A summary from that population, if available, would describe the participants with observed questionnaire data who satisfied the stated criteria. Without information about participants who died, were lost, or did not complete a questionnaire, it would not necessarily describe the full enrolled group.
The registry lists three deaths in the group titled “Patients With Advanced Disease.” This count is not an outcome comparison and should not be combined with the quality-of-life endpoint. The registry’s listed serious and other event fields show zero for the at-risk and affected counts, and no top serious-event terms are listed. Those entries do not provide the missing FACT-B results, nor do they establish a complete account of safety outcomes.
Because the study is observational and no comparator is described, it cannot be read as a randomized estimate of the effect of connected technologies. Differences between people who are followed remotely and any other patients, if such a comparison existed, could reflect differences in their characteristics, care, or follow-up rather than the technology. The registry does not report an adjusted analysis or a comparison result.
The planning assumptions describe an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. These are planning assumptions, not a description of the actual observational design. The observed effect and the numerical planning outputs are not reported in the registry record. Such illustrations should not be interpreted as observed power or as evidence that the study detected an effect.
Overall, the record establishes the study setting, the stated primary measure, and the criteria for its outcome population. It does not report the primary-outcome values or analyses needed to quantify quality of life, estimate uncertainty, or make a comparative claim. The study’s completed status does not change that distinction between a registered endpoint and a posted result.
9. Statistical Methods Explained
What does an observational design imply?
In general, an observational study records what occurs without specifying randomized assignment by the study. It can describe participants, care, and outcomes, but causal interpretation is more difficult than in a randomized comparison because groups may differ for reasons other than the intervention. In e-DomSanté, allocation is not stated, and the record does not describe a control group. The planning illustration’s assumptions about two arms should not be mistaken for evidence that the study used two actual arms.
Without a stated comparison condition, the primary FACT-B endpoint is best understood as a planned description of quality of life in a defined participant population. A single score summary can characterize observed respondents, but it cannot by itself separate the contribution of remote follow-up from the many other influences on a person’s reported quality of life. The record does not report an adjusted comparison that would address differences among groups.
What does a median and full range describe?
The primary endpoint is specified as a median with a full range. In general, the median is the midpoint of ordered observations: it summarizes the center without requiring the values to be symmetrically distributed. The full range gives the extreme observed values and illustrates how far apart the lowest and highest scores are. Neither statistic describes every feature of a distribution. The range, in particular, can be influenced by extreme observations.
A median and range are descriptive summaries. They do not on their own provide a confidence interval, a test of a hypothesis, or an estimate of a difference between groups. A confidence interval, as a general statistical concept, expresses a range of values compatible with an estimation procedure and its assumptions. No confidence interval for FACT-B is reported in the registry record, and there is no reported comparison estimate to which one could apply.
The scale runs from 0-148, and the registry states that higher scores indicate better quality of life. That scoring direction helps explain the meaning of an observed value, but no observed value is reported. It would therefore be inappropriate to characterize participants’ quality of life as high, low, improved, or unchanged on the basis of this record.
Why does the defined outcome population matter?
The primary endpoint applies to patients alive, not lost to follow-up, and with a completed questionnaire. This is a complete-observation population defined by survival, follow-up status, and questionnaire completion. In general, restricting an outcome summary to observed respondents can make the result different from the result that would have been obtained had everyone enrolled contributed an assessment. This is especially relevant when reasons for missing assessments may be related to health or quality of life.
The record does not report the number of eligible respondents, the number who lacked a questionnaire, or the reasons assessments were unavailable. It also does not describe imputation, weighting, sensitivity analyses, or another method for addressing missing data. No missing-data method should be inferred from the stated population definition alone.
What can be understood from the planning assumptions?
The registry includes assumptions for a sample-size planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the target effect as a stated fraction of the observed effect. These assumptions describe a planning calculation rather than the design or analysis of the observational study. Equal allocation is a hypothetical calculation condition here, not proof of actual group assignment.
In general, a planning calculation estimates how much information might be needed to detect a specified effect under stated assumptions. It depends on the effect size, variability, allocation, and chosen error criterion. A planning sample size is not a report of how many participants were analyzed, and it is not an observed measure of power. The registry record does not report the observed effect or a numerical justification for the enrollment target. The record also does not report enough endpoint results to assess how closely any planning assumptions matched the observed data.
The assumptions refer to a normal approximation, but the registry does not report the sample-size calculation’s detailed method or the numerical outputs in this record. General concerns about an approximation depend on the outcome distribution and the analysis being planned; those details are not reported. No further distributional or design assumptions should be attributed to the trial.
What analyses are actually reported?
The registry lists two outcome measures and zero analyses. That combination means the record identifies outcomes but does not provide a statistical analysis result for them. It does not report a test statistic, p-value, confidence interval, or effect estimate for the primary endpoint. The specified median and range are the planned form of summary, not an observed result.
The registry reports three deaths for the listed advanced-disease group. This is a count recorded separately from the FACT-B endpoint. It does not provide a time-to-event analysis or a comparison of mortality between groups. The record does not report an analysis population for such a comparison or any adjustment for participant characteristics.
Statistical methods should be interpreted in relation to the question and data actually reported. Here, the record supports a description of the design classification, the endpoint definition, and the planning assumptions. It does not support a quantitative inference about the primary outcome. The protocol, analysis plan, multiplicity approach, and handling of missing measurements are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures, but the details of the second measure are not reported in the registry record summarized for this analysis. The primary outcome is identified as FACT-B quality of life at 12 months. No multiplicity plan is reported in the registry record. In general, when several outcomes or analyses are examined, a prespecified approach to multiplicity can clarify how the chance of false-positive findings is managed. No such approach should be assumed.
The number of analyses is listed as zero, and no primary-outcome result is reported. The record therefore does not show whether analyses were planned but not entered, whether results were unavailable, or whether another explanation applies. The analysis plan and any interim analyses are not reported in the registry record.
The primary endpoint population includes people alive, not lost to follow-up, and with a completed questionnaire. The number of people meeting those criteria is not reported. The record does not state how many participants were lost to follow-up, how many questionnaires were incomplete or absent, or why data were unavailable. It also does not report imputation, sensitivity analyses, or another missing-data procedure.
These exclusions can matter for interpretation. A complete-questionnaire summary describes the participants with observed data who meet the stated eligibility conditions; it is not automatically a summary for everyone enrolled. Because the record does not give the relevant counts or missingness patterns, the extent or direction of any resulting selection cannot be assessed.
The record does not define analysis populations beyond the primary endpoint’s stated population, and does not describe how deaths relate to any other outcome analysis. Further details of the statistical plan, including multiplicity, missing-data handling, and analysis populations, are not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The record identifies a study of remote follow-up technologies in people treated for metastatic breast cancer who live far from their comprehensive cancer center. It states that quality of life was to be assessed at 12 months with FACT-B, using a median and full range among patients alive, not lost to follow-up, and with a completed questionnaire. These are design and endpoint details, not evidence of an observed outcome.
No FACT-B score, range, or analysis result is reported in the registry record. As a result, the record does not show what quality of life was among the eligible respondents, how much scores varied, or how precisely any quantity was estimated. It also does not provide evidence that scores increased, decreased, or remained stable over time.
The study is observational, and no comparator is described. It therefore does not establish a randomized contrast between remote follow-up and another approach. Even if a descriptive score were available, it would not by itself demonstrate that telemedicine, connected watches, or symptom monitoring caused that score. Causal interpretation would require an appropriate comparison and careful consideration of other explanations; those details are not reported.
The primary endpoint is limited to survivors with follow-up and a completed questionnaire. It does not represent, by definition, all enrolled participants. The registry does not report how many people met the endpoint criteria or how those with missing assessments differed from respondents. The listed three deaths are a separate recorded count and do not fill in the missing quality-of-life information.
The record can therefore support a description of the registered study question and its intended measurement, but not a conclusion about the magnitude, direction, or clinical importance of a quality-of-life result. It cannot establish comparative effectiveness or a safety conclusion. The completed status of the study and the planning assumptions do not substitute for posted outcome data.
12. Why This Trial Matters Statistically
This record is statistically informative in part because it makes a clear distinction between an endpoint definition and an endpoint result. e-DomSanté specifies a patient-reported quality-of-life measure, its scoring direction, its assessment time, and the population for whom the summary was intended. Those features allow readers to understand what information the study sought to describe.
The population definition also highlights an important issue in observational research: the analyzed respondents may differ from the enrolled participants. Here, inclusion in the primary endpoint depends on being alive, retained in follow-up, and completing the questionnaire. Without counts and information about those not represented, readers cannot judge the extent to which the recorded respondents reflect all enrolled patients.
The study setting also illustrates why design labels matter. A registry entry about connected technologies does not, by itself, define a controlled comparison. The study is identified as observational, allocation is not stated, and no comparator is described. These details set limits on what a statistical analysis could establish, even if a descriptive result were available.
Finally, the record distinguishes planning assumptions from trial results. Assumptions involving equal allocation between two arms belong to a planning illustration; they do not establish that the study had randomized arms. Since outcome values and analyses are not reported, the illustration cannot be treated as observed power or as evidence of an effect. Clear reporting of results, analysis populations, and missing-data handling would be needed to move from an endpoint definition to a quantitative 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 most direct limitation is that the registry record does not report the primary FACT-B result. Without the median and full range, there is no quantitative description of quality of life at 12 months. No confidence interval or other measure of precision is reported, and the number of analyses is listed as zero.
The enrolled population is small as recorded, with enrollment of 15, but the endpoint population may be narrower because it excludes patients who were not alive, were lost to follow-up, or did not complete the questionnaire. The number meeting these conditions is not reported. The effect of these exclusions cannot be assessed without counts and information about missing assessments.
The study is observational, and no allocation method or comparator is described. This limits the interpretation to the study context and prevents a supported randomized comparison. The record also does not explain which connected technologies were used in practice, how often remote monitoring occurred, or whether all participants received the same follow-up procedures.
Details of the second outcome measure are not reported in the registry record summarized for this analysis. The protocol, sample-size justification, analysis plan, missing-data methods, multiplicity approach, and any interim analyses are also not reported in the registry record. The planning assumptions do not resolve these gaps or establish the actual design.
The record lists three deaths in the advanced-disease group. It does not provide further analysis of those deaths or link them to a comparative outcome assessment. The zero entries in the listed event fields and absence of top serious-event terms should not be treated as a complete evaluation of all possible safety outcomes.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Evaluation of Efficiency in Cancerology of New Technologies as Telemedicine and Conected Objects (e-DomSanté) — NCT03359759.
- Registry record last updated 2025-12-10; status last verified 2025-11.
- Results first posted 2025-12-10.
- 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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17. Record Summary
e-DomSanté is a completed observational study sponsored by Institut Bergonié, with enrollment of 15. The registry lists a start of 2016-01 and a primary completion of 2016-12. It concerns remote follow-up for patients treated for metastatic breast cancer who live far from their comprehensive cancer center, using telemedicine, connected watches, and patient-reported symptom monitoring.
The primary outcome is FACT-B quality of life at 12 months, summarized by a median and full range among patients alive, not lost to follow-up, and with a completed questionnaire. The scale ranges from 0-148, with higher scores indicating better quality of life.
No primary-outcome result or analysis is reported in the registry record. The record lists two outcome measures and zero analyses; the second outcome’s details are not reported. Allocation and a comparator are not stated. Three deaths are listed for the advanced-disease group, while the listed serious and other event fields have zero at-risk and affected counts.