Evaluating Smoking Cessation Protocols in Cancer Patients: NRT, MI, CBT or Hypnotherapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluating Smoking Cessation Protocols in Cancer Patients: NRT, MI, CBT or Hypnotherapy (NCT04899492), a randomized na study. The primary outcome is Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery.

2. Clinical Question

The trial’s stated focus is the feasibility of smoking-cessation interventions in French cancer patients undergoing surgery. Its primary outcome is a count of participants who completed every planned session, considered out of the participants randomized to each group. The outcome therefore asks whether the intervention schedule was completed, rather than measuring smoking abstinence, tobacco use, or a clinical outcome.

The registry record describes NRT alone and three NRT-based packages that add MI, CBT, or hypnotherapy. The packages do not differ by only one component: the CBT and hypnotherapy groups also include MI. Any comparison across groups would therefore address the assigned packages as a whole, not isolate the effect of a single behavioral component.

The posted outcome reports zero participants completing all planned sessions in every group. That count addresses the recorded feasibility measure, but it does not explain why sessions were not completed or whether participants had other forms of engagement. Reasons for noncompletion are not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group pilot study with no masking. The registry record lists 21 participants enrolled and a terminated study status. The listed start date is 2021-09-29, and the primary completion date is 2024-03-29. The phase is recorded as NA. The reason for termination is not reported in the registry record.

Four groups were listed. Participants in the NRT group received NRT from study entry to the end of the study. The MI group received NRT over the same stated period and 1 to 3 MI sessions after randomization. The CBT group received NRT, 1 to 3 MI sessions, and 6 CBT sessions after MI, up to 6 months after. The hypnotherapy group received NRT, 1 to 3 MI sessions, and about 3 hypnotherapy sessions, up to 6 months after.

The posted group sizes were 6.0 for NRT, 3.0 for MI, 6.0 for CBT, and 6.0 for hypnotherapy. Allocation is described as randomized, but the method used to generate or conceal the allocation sequence is not reported in the registry record. Masking is listed as none; further details about who knew group assignments are not reported.

These are four intervention packages, not four arms that differ solely by the presence or absence of one therapy. All groups received NRT, while the CBT and hypnotherapy packages included MI as well as their named additional therapy. This structure matters when interpreting any between-group contrast: it cannot isolate the contribution of CBT or hypnotherapy alone. The registry record does not report the reason for the unequal posted group sizes or a recruitment target.

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

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 Testing the Feasibility of Smoking Cessation Interventions Evaluated in French Cancer Patients Undergoing Surgery, measured over 12 months.

The primary outcome is the number of participants who completed all planned sessions, out of the total number randomized to each group, assessed at 12 months. It is a feasibility measure: it describes completion of the assigned session schedule. The registry reports a count of 0 in the NRT group, 0 in the MI group, 0 in the CBT group, and 0 in the hypnotherapy group.

This measure is useful for describing whether a multi-session protocol was completed as intended. In a pilot study, such information can help characterize the practical delivery of an intervention. However, completion is not the same as smoking cessation. The primary outcome does not count participants who quit smoking, measure the duration of abstinence, or establish whether smoking behavior changed. Those outcomes are not reported in the registry record.

The endpoint also does not identify the circumstances behind a participant’s completion status. The registry does not report whether participants missed sessions, withdrew, became ineligible, or encountered another reason for not completing the full schedule. Nor does the posted count indicate whether a participant received some, but not all, planned sessions. These distinctions matter for understanding feasibility, but cannot be recovered from the completion counts alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a randomized, parallel-group design mean?

In a randomized trial, assignment to groups is intended to reduce systematic differences between groups at the point of allocation. A parallel-group design means participants are assigned to a group and receive that group’s intervention package, rather than switching through all packages. Randomization does not guarantee that groups will be similar in every characteristic, particularly when group sizes are small. The record identifies the design as randomized and parallel, but the randomization procedure and allocation concealment are not reported in the registry record.

What does the primary count represent?

The primary outcome is a binary participant-level status: either the participant completed all planned sessions or did not. The posted result expresses the endpoint as a count of completed participants for each group. General statistical principle: for a binary outcome, a group count is usually interpreted alongside the number of participants assessed or randomized, and comparisons can be expressed using measures such as a difference in event proportions. The registry record does not post an estimable two-group comparison for this outcome, so no such effect estimate is available.

Why is there no inferential comparison?

The registry record reports zero participants meeting the completion endpoint in every group and states that values are missing or not estimable for a two-arm binary comparison. In general, an inferential analysis uses the observed outcome data to estimate a contrast and its uncertainty. If the analysis cannot produce a meaningful estimate, it cannot support a confidence interval or a test result. The record reports zero analyses, so there is no sponsor analysis or other inferential result to interpret. No alternative model or adjustment strategy is reported in the registry record.

General statistical principle: a confidence interval describes the precision of an estimate, while a p value evaluates compatibility of data with a specified null hypothesis under an analysis model. Neither can be inferred just from the group counts. The absence of these statistics does not mean that an effect was shown to be absent; it means the record does not provide an inferential estimate for the comparison.

How should planning calculations be understood?

General statistical principle: sample-size calculations are planning tools that describe the number of participants an assumed design might need to detect a chosen effect with a chosen error rate. They are not evidence about what happened in the trial, and they are not observed power. The registry record describes a planning approach using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also describes considering a stated fraction of the observed effect. These are planning assumptions, not a reported justification for the trial’s enrolled sample size.

The record does not report a numeric trial-specific sample-size justification. Because no two-arm comparison is estimable for the posted binary endpoint, a usable effect estimate for a planning illustration is not available in the record. Any planning calculation that relies on an observed effect must be interpreted cautiously in general: pilot estimates can be unstable, and an effect observed in a small study may not represent the effect in a later study. Such calculations would remain planning illustrations rather than evidence that the trial had adequate power.

What can be inferred from the design and posted results?

Random allocation and the parallel design describe how groups were organized, but they do not resolve the limits of the posted outcome data. The trial was unmasked, so participants and study personnel were not blinded according to the registry entry. General statistical principle: awareness of assignment can affect behavior, intervention delivery, and outcome recording, depending on the outcome and procedures. The record does not report steps taken to standardize completion assessment or reduce assessment bias.

The interventions are layered packages. NRT is common to all groups; the MI group adds MI, and the CBT and hypnotherapy groups include MI along with their named therapy. Thus, even if a group contrast had been posted, it would compare packages and would not isolate the effect of each component. No analysis comparing smoking outcomes is reported. The methods that would be needed to interpret such an outcome—including its definition and assessment schedule—are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Group 1:Nicotine Replacement Therapy (NRT)", "Group 2:Motivational Interviewing (MI)", "Group 3:Cognitive Behavioural Therapy (CBT)", "Group 4: Hypnotherapy")
n      <- c(6, 3, 6, 6)
events <- c(0, 0, 0, 0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Group 1:Nicotine Replacement Therapy (NRT)  6  0  0.0  0.0  45.9  0.0  39.0  0.4  41.0
ARM  Group 2:Motivational Interviewing (MI)  3  0  0.0  0.0  70.8  0.0  56.1  0.6  60.2
ARM  Group 3:Cognitive Behavioural Therapy (CBT)  6  0  0.0  0.0  45.9  0.0  39.0  0.4  41.0
ARM  Group 4: Hypnotherapy  6  0  0.0  0.0  45.9  0.0  39.0  0.4  41.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure and no posted secondary outcomes. It reports zero analyses. No statistical analysis plan, prespecified comparison hierarchy, or approach to multiple testing is reported in the registry record. Multiplicity is a general concern when many outcomes or contrasts are tested: the more opportunities there are to find a result, the more important it is to define in advance how those tests will be interpreted. With no analyses posted, the record does not show whether any multiplicity adjustment was used or needed.

The endpoint is defined as the number completing all planned sessions out of the number randomized to each group, but the record does not explain how missing outcome information was handled. It does not report a missing-data method, imputation, sensitivity analysis, or participant flow by outcome status. The zero counts are the posted completion results; they should not be taken as a detailed account of every randomized participant’s follow-up or reason for noncompletion.

The analysis population is also not described beyond the endpoint’s reference to participants randomized to each group. The registry record does not state whether results were analyzed by intention to treat, per protocol, or another population definition. It does not report exclusions from analysis or how participants who did not complete assigned sessions were treated in any inferential analysis. Since no analyses are posted, the record cannot establish how these choices affected a treatment comparison.

These omissions matter because different missing-data and analysis-population choices can alter the interpretation of a feasibility count. They also make it difficult to assess whether the posted counts represent all randomized participants consistently. No assumptions about these procedures should be inferred from the randomized design alone.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event record reports no serious adverse events in any group: 0 among 6 participants in the NRT group, 0 among 3 in the MI group, 0 among 6 in the CBT group, and 0 among 6 in the hypnotherapy group. For other adverse events, the record reports 1 participant in the NRT group, 0 in the MI group, 1 in the CBT group, and 0 in the hypnotherapy group.

The deaths field reports 1 death in the NRT group, 0 in the MI group, 1 in the CBT group, and 1 in the hypnotherapy group. The registry record does not report whether these deaths were considered related to an intervention, their causes, or their timing. The death counts should therefore be read as reported counts, not as evidence that an intervention caused a death.

Adverse-event counts and death counts are distinct summaries and should not be added together as though they were mutually exclusive categories. The record does not provide event descriptions for the non-serious events or serious-event terms. With these small group sizes, the counts describe what was recorded but do not provide a precise comparative safety estimate. No causal safety comparison is reported.

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

The result establishes that the registry’s recorded count of participants completing all planned sessions was 0 in each of the four groups. This is a descriptive finding about the defined feasibility endpoint. It does not show that no participant attended any sessions, because the endpoint counts only those who completed all planned sessions. The registry record does not report the number who attended some sessions or why participants did not complete the full schedule.

The outcome does not measure smoking cessation. It cannot show how many participants stopped smoking, whether smoking behavior changed, or whether the different packages had different effects on smoking. Those outcomes are not reported in the registry record. Likewise, the absence of an estimable comparison means the posted information cannot establish that the packages have the same or different completion rates.

The findings also do not explain the study’s terminated status. The reason for termination is not reported in the registry record, so the status should not be interpreted as evidence of a particular operational, clinical, or safety issue. Nor do the adverse-event counts establish a causal relationship between an intervention and an event; the record does not report attribution.

General statistical principle: a descriptive result answers what was recorded in the analyzed group, whereas a causal comparison requires a suitable analysis of differences between groups and an assessment of uncertainty. Randomization is a design feature that can support causal inference, but it does not replace the analysis or make an unestimable comparison interpretable. Here, the posted record provides group-level feasibility counts and safety counts, but no inferential estimates. The appropriate conclusion is therefore limited to those counts and the information not reported.

14. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between an intervention’s feasibility and its efficacy. Completing a prescribed series of sessions is a delivery and engagement outcome. It may be relevant when assessing whether a protocol can be implemented, but it does not answer whether smoking cessation occurred. Keeping these outcomes separate prevents a process measure from being mistaken for a clinical or behavioral outcome.

The layered design also illustrates a common challenge in multi-arm behavioral studies. NRT was included in all groups, and the CBT and hypnotherapy packages also included MI. A contrast between packages would therefore not identify the effect of a single added component. Clear interpretation depends on matching the scientific question to the actual differences among assigned groups.

The record further shows why a randomized label alone is not enough to interpret a trial. The posted endpoint counts are descriptive, and no analyses or estimable two-arm comparison are reported. Without an effect estimate and its uncertainty, readers cannot judge comparative precision. The small, unequal group sizes make cautious interpretation especially important, but they do not by themselves explain the missing analysis or the trial’s termination.

Finally, the separation of feasibility results from safety counts matters. The registry lists no serious adverse events, some other adverse events, and deaths in three groups, but it does not provide attribution or a comparative safety analysis. Statistical interpretation should preserve that distinction: reported event counts describe the record, while causal conclusions require information and analyses not present in the registry record.

15. 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 primary endpoint is narrowly defined as completion of all planned sessions. It does not capture partial participation, reasons for noncompletion, or smoking behavior. The registry record does not report the number of participants completing some sessions or explain whether each planned session was delivered as intended. Consequently, the posted zeros do not provide a detailed picture of acceptability or intervention delivery.

The enrolled group sizes were 6.0 for NRT, 3.0 for MI, 6.0 for CBT, and 6.0 for hypnotherapy. These small groups limit how much can be learned about differences between packages, and the MI group is smaller than the other listed groups. No inferential analysis is posted, and no two-arm comparison is estimable for the binary endpoint. The record therefore supplies no comparative estimate or measure of its precision.

The packages are not component-isolating comparisons. CBT and hypnotherapy groups included MI as well as their named additional intervention, while all groups received NRT. This limits attribution of any hypothetical difference to an individual component. The study was unmasked, and the registry record does not describe procedures for blinded outcome assessment.

Other important details are not reported in the registry record: the randomization procedure, reasons for termination, participant flow, missing-data handling, analysis populations, and a trial-specific sample-size justification. Smoking cessation outcomes and secondary outcomes are also not posted. These limitations constrain interpretation to the recorded feasibility and adverse-event counts; they do not establish why the results or analyses are absent.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluating Smoking Cessation Protocols in Cancer Patients: NRT, MI, CBT or Hypnotherapy — NCT04899492.
• Registry record last updated 2026-08-07; status last verified 2024-11.
• Results first posted 2026-08-07.
• 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.

19. Record Summary

The registry describes a randomized, unmasked, parallel pilot study in cancer patients scheduled for surgery, with NRT alone compared with NRT-based packages including MI, CBT, or hypnotherapy. The listed cancer conditions are breast cancer, gynecologic cancer, digestive cancer, and melanoma. Enrollment is 21, and the study status is terminated.

The primary outcome, assessed at 12 months, counts participants completing all planned sessions. The posted count is 0 in each group. No analyses are reported, and a two-arm comparison of the binary endpoint is not estimable in the registry record. No secondary outcomes are posted. The adverse-event record lists no serious adverse events, other adverse events in the NRT and CBT groups, and deaths in the NRT, CBT, and hypnotherapy groups; attribution is not reported.

The registry record does not report the reason for termination, smoking cessation results, an inferential comparison, or a trial-specific sample-size justification. Interpretation is limited to the posted counts and the study design details.