Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors (NCT03661840), a randomized na study. The primary outcome is The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact].

2. Clinical Question

The central clinical research question is whether physical-health scores, as assessed over the stated timeframe, differ in a trial comparing ACT plus usual medication management with Treatment as Usual. The randomized allocation is relevant because, in general, randomization is intended to support a fair comparison of groups. It does not by itself establish that the groups were similar in every respect or that a particular effect was observed.

The registry also lists secondary outcomes concerning participants’ interest in using ACT for chronic pain after active cancer treatment, how much they enjoy using ACT, and the reliability and validity of strategies for monitoring ACT fidelity. These address acceptability and implementation alongside the primary physical-health measure. Their listed presence does not establish what participants reported or whether treatment fidelity was achieved. Numerical outcome findings for these questions are not reported in the registry record.

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. One group received Acceptance and Commitment Therapy together with medication management given as usual treatment; the comparator group received Treatment as Usual, described as ongoing usual pain-management options. The registry lists an enrollment of 50. It does not report the number assigned to each group as a randomization result, the allocation sequence method, or whether the enrolled number equals the number included in each outcome analysis.

The study is listed as completed. The recorded start date is 2018-12-04, and the primary completion date is 2021-03-04. The phase is listed as NA. The sponsor is University of Colorado, Denver. These record details describe the trial’s registration, not the outcome findings.

The primary outcome is a continuous measure summarized using a mean and standard deviation. It uses the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health, on a scale with a minimum of 0 and a maximum of 100; higher scores are better. The listed timeframe is from baseline to 12 weeks post intervention. The registry record does not provide outcome values, a group contrast, a confidence interval, or a p-value for this measure. It also does not provide enough detail to establish whether the analysis compared follow-up scores, change from baseline, or another representation of the repeated measurements.

The record lists five outcome measures and three analyses. It does not report the statistical model, analysis population, missing-data procedure, or method for handling multiple outcomes. Randomization and a parallel-group structure describe the broad design, but these registry entries alone do not specify how results were analyzed or how precise any treatment contrast was.

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 The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact], measured over From baseline to 12 weeks post intervention.

The primary outcome is titled “The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact].” It assesses physical health using the Medical Outcomes Study 36-Item Short Form Health Survey. The registry describes the measure as a continuous scale with a minimum of 0 and a maximum of 100, with higher scores indicating better physical health. The outcome is summarized as a mean with standard deviation, and its timeframe is from baseline to 12 weeks post intervention.

A physical-health measure can be relevant in a study of chronic pain because it captures a dimension of participants’ health rather than only whether they received or accepted an intervention. In general, a scale score offers a structured way to describe participants’ reported health, while a comparison between randomized groups would be needed to estimate how the groups’ measured outcomes differed. That is a general explanation of the role of an endpoint, not a claim about the result of this trial.

The registry does not report the group means, standard deviations, number analyzed for this endpoint, or a between-group estimate. It also does not clarify how the baseline-to-follow-up timeframe was represented in the analysis. As a result, the direction, size, and precision of any difference in physical-health scores are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical details registered for this trial are limited. The primary outcome is continuous, expressed as a mean with standard deviation, and the broad design is randomized and parallel-group. The registry also reports planning assumptions for a sample-size illustration: a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. These are assumptions for planning illustrations, not evidence that the trial used those choices in its own analysis.

What does a mean and standard deviation describe?

In general, a mean describes the center of a set of numerical observations. A standard deviation describes how dispersed observations are around that center. For the physical-health endpoint, these summaries would help describe the score distribution within each group. They do not, by themselves, provide a between-group estimate or show how uncertain that estimate is. The registry record does not report the primary-outcome means or standard deviations.

What would a group comparison estimate?

In general, a randomized trial’s group comparison estimates how the measured outcomes differed between the assigned groups under the analysis used. The interpretation depends on the outcome definition and statistical model. For an outcome collected over time, analysis might compare follow-up values or represent change from baseline; those approaches answer related but not identical questions. The registry record gives a baseline-to-12-weeks-post-intervention timeframe but does not report the specific model or contrast used. No numerical group comparison is reported.

How should confidence intervals and p-values be read?

In general, a confidence interval communicates the uncertainty around an estimated effect: a narrower interval indicates greater precision under the model and assumptions used, while a wider interval indicates less precision. A p-value describes how compatible the data are with a specified null hypothesis under a statistical model; it does not measure the size or importance of an effect. Neither a confidence interval nor a p-value for the primary endpoint is reported in the registry record. The planning significance level of 0.05 should not be mistaken for a reported outcome p-value or proof of the trial’s analysis threshold.

What do the sample-size assumptions mean?

The registry’s sample-size assumptions describe planning illustrations based on an observed effect, with the target effect expressed as a fraction of that observed effect. Equal allocation and a normal approximation are also stated assumptions. These illustrations are not the trial’s reported design justification, and they are not observed power. They do not show that the trial had a particular probability of detecting an effect after the data were collected. The registry record does not report the trial’s own sample-size justification or the numerical planning results.

In general, planning estimates depend on the effect size chosen, the variability of the outcome, the significance level, and the desired power. If an assumed effect is smaller, detecting it generally requires more information, all else being equal. That general relationship helps explain why planning results should be read as conditional illustrations rather than guarantees. No additional sample-size calculation can be inferred from the enrollment figure alone.

What is not specified about the analysis?

The registry lists three analyses and five outcome measures, but does not report the model, covariates, treatment-effect estimand, analysis population, or procedures for missing data. It also does not report whether there were interim analyses or how the analysis addressed multiple outcomes. These omissions mean that readers cannot reconstruct the statistical analysis or assess whether it followed a prespecified plan. Such details are not reported in the registry record.

In general, over-dispersion matters when variability is greater than a chosen statistical model expects. A model that understates variability can produce uncertainty estimates that are too narrow. This is a general concept; the registry does not indicate that over-dispersion was relevant to this continuous physical-health outcome or that a particular adjustment was used. Likewise, the registry’s description of a continuous measure does not establish that distributional assumptions were checked or met.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and three analyses. It identifies a primary physical-health outcome and lists secondary outcomes addressing interest in ACT, enjoyment of ACT, and fidelity-related strategies. The record does not explain whether the remaining registered measures were treated as additional secondary outcomes, how each analysis related to each measure, or which findings were considered confirmatory.

When a study examines multiple outcomes or makes multiple statistical comparisons, the chance of obtaining at least one apparently unusual result can increase. In general, multiplicity procedures can be used to control that risk, but they may also affect the interpretation or precision of individual comparisons. The registry record does not report whether any multiplicity adjustment or hierarchy of testing was used. No significance results are reported for the outcomes listed.

The registry record also does not report the number of participants with observed primary-outcome data at baseline or follow-up, the handling of missing measurements, or the analysis population. Missing data can affect both the amount of information available and the interpretation of the result, depending on why data are missing and how the analysis addresses them. The record does not state whether participants were analyzed according to randomized assignment, according to treatment received, or using another population definition.

These gaps limit assessment of the reliability and scope of any potential statistical claims. The registered outcome list and analysis count indicate that several measures or analyses were planned, but they do not reveal the full analysis plan. The missing details are not reported in the registry record.

11. 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.

For Acceptance and Commitment Therapy, the registry lists 28 participants at risk for serious adverse events and 0 affected. For Treatment as Usual, it lists 22 participants at risk and 0 affected. The registry also lists 0 other adverse events in each group and 0 deaths in each group. These figures describe the recorded counts in the registry; they do not establish that no adverse experiences occurred beyond the categories and reporting represented in the record.

In general, a count of zero in a trial’s adverse-event record should be read in relation to the number of participants observed and the way events were defined, collected, and reported. A zero count is not proof that an event is impossible, and it does not by itself establish equivalence in safety between groups. The registry record does not provide additional detail about adverse-event definitions, surveillance procedures, duration of safety follow-up, or event-specific categories. It lists no top serious adverse-event terms.

The at-risk counts are group-specific registry figures and should not be treated as proof that every enrolled participant contributed complete safety follow-up. The record does not describe the safety analysis population or missing safety data. These figures are descriptive counts, not estimates of comparative risk.

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

The record identifies a completed randomized trial of ACT for chronic pain in cancer survivors after active cancer treatment. Its primary outcome was physical health measured with the Medical Outcomes Study 36-Item Short Form Health Survey over a timeframe from baseline to 12 weeks post intervention. The scale runs from 0 to 100, with higher scores better. These details clarify the question and measurement, but the registry does not report the numerical primary-outcome results.

Accordingly, the posted information does not establish whether ACT plus usual medication management was associated with higher or lower physical-health scores than Treatment as Usual, or whether any difference was precise, statistically distinguishable from no difference, or clinically important. There are no reported group estimates, effect estimates, confidence intervals, or p-values for that outcome. The same limitation applies to the listed secondary outcomes: their topics are described, but their results are not reported in the registry record.

The study’s randomized design is a useful feature for a comparative question in general, but a design description is not a finding. Interpretation also depends on the participants who contributed data, the statistical model, missing-data handling, and multiplicity decisions. These details are not reported in the registry record, so the underlying analysis cannot be assessed from the registered information alone.

The adverse-event figures describe zero recorded serious events, other events, and deaths in each group, with group-specific at-risk counts of 28 and 22. Those counts are descriptive and do not prove that no events could occur or that the groups have identical safety profiles.

The most appropriate conclusion is therefore about the scope of the evidence available in the registry: the trial’s design, intervention comparison, outcome definition, and some safety counts are recorded, while numerical efficacy outcomes and important analysis details are not reported. No conclusion about treatment benefit or lack of benefit follows from the absence of posted outcome estimates.

13. Why This Trial Matters Statistically

This trial raises a clinically relevant statistical question: how to evaluate a behavioral intervention alongside usual medication management against usual pain-management options for chronic pain in cancer survivors. Its focus on physical health gives the primary outcome a defined measurement target, while the secondary outcomes extend attention to acceptability and fidelity. Statistical interpretation depends not only on the topic of an intervention but also on how outcomes are defined, compared, and reported.

The randomized, parallel-group design provides a recognizable framework for comparing assigned groups. In general, randomization can support causal interpretation when assignment, follow-up, and analysis are handled appropriately. The registry record, however, does not provide enough information to assess those later steps or to estimate the primary contrast. This distinction is important: design features describe how a study is organized, whereas outcome estimates describe what the observed data show.

The record also illustrates why an outcome scale’s range and direction are useful but insufficient. Knowing that physical-health scores range from 0 to 100 and higher is better helps orient a reader to the measure. Without group summaries and an estimate of uncertainty, it cannot answer whether the groups differed or how precisely any difference was measured.

Finally, the registered planning assumptions should be separated from observed findings. Planning illustrations based on assumed effects are conditional calculations, not evidence of observed power or confirmation that the trial’s design justification used those assumptions. Clear reporting of outcome estimates, uncertainty, analysis populations, and missing-data methods is essential for readers to judge what a completed trial contributes. Those details are not reported in the registry record.

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 main limitation for interpreting this trial from the registry record is the absence of numerical results for the primary physical-health outcome. Group means, standard deviations, a treatment contrast, and an uncertainty interval are not reported. Without them, the direction, magnitude, and precision of the primary comparison cannot be assessed.

The record gives the outcome timeframe as baseline to 12 weeks post intervention but does not specify how the repeated measurements were represented in the analysis. It does not report the statistical model, any baseline adjustment, the analysis population, the number analyzed for the endpoint, or the approach to missing data. These omissions prevent assessment of how the primary estimate would relate to participants’ baseline scores or to incomplete follow-up.

The registry lists five outcome measures and three analyses, but it does not describe how analyses mapped to outcomes or whether multiplicity was addressed. Numerical results for the secondary outcomes concerning ACT interest, enjoyment, and fidelity are also not reported. Therefore, neither the breadth of findings nor the interpretation of multiple comparisons can be evaluated.

Further trial details are also limited. The registry does not report the allocation sequence method, intervention delivery details, specific usual-care options, or further eligibility criteria. It does not give the trial’s sample-size justification, interim-analysis information, or a full statistical analysis plan. These matters are not reported in the registry record and should not be inferred from the broad design labels or planning assumptions.

The safety information is limited to event counts and numbers at risk, without further definitions or surveillance details. These limitations concern what can be concluded from the registry record; they do not establish that the corresponding procedures or information were absent from the trial itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors — NCT03661840.
• Registry record last updated 2025-03-13; status last verified 2025-03.
• Results first posted 2024-01-03.
• 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.

18. Record Summary

The registry record describes a completed randomized, unmasked, parallel-group trial sponsored by University of Colorado, Denver. It lists an enrollment of 50 and compares Acceptance and Commitment Therapy plus usual medication management with Treatment as Usual for chronic pain in cancer survivors after active cancer treatment. The recorded start date is 2018-12-04, and the primary completion date is 2021-03-04; phase is listed as NA.

The primary outcome is physical health measured by the Medical Outcomes Study 36-Item Short Form Health Survey, with a 0-to-100 scale on which higher scores are better. Its timeframe is from baseline to 12 weeks post intervention. The registry lists five outcome measures and three analyses, but numerical primary and secondary outcome results are not reported in the registry record. Safety counts list no recorded serious adverse events, other adverse events, or deaths in either group.