Be-Active Study - Increasing Physical Activity in Cancer Survivors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Be-Active Study - Increasing Physical Activity in Cancer Survivors (NCT05376293), a randomized na study. The primary outcome is Change in Physical Activity.

2. Clinical Question

The study focuses on a behavioral outcome rather than a clinical event. Its primary endpoint is change in physical activity, and positive values represent increases from baseline. The registry description also identifies intervention engagement and program satisfaction as primary aims, but posted numerical results for those measures are not reported in the registry record. The reported arm comparison therefore addresses the physical-activity change outcome, not every aim described in the study summary.

The question is comparative: it concerns the mean changes reported for the Internet program and newsletter arms. The registry record identifies a randomized, parallel study with no masking. Random assignment can support a comparison between assigned groups, but interpretation still depends on the outcome data, the analysis used, and how missing observations were handled. Details of those analysis procedures are not reported in the registry record.

The registry summary describes the study as planning to randomize 50 cancer survivors, while the enrollment field records 46. These are different registry entries with different roles: one describes the study plan and the other records enrollment. The posted primary outcome includes 22 participants in each arm. The record does not explain the difference between the planned and recorded enrollment figures.

3. Trial Design

The registry record identifies NCT05376293 as the Be-Active Study, with the official title Web-based Intervention for Increasing Physical Activity in Cancer Survivors. The study is listed as completed. It began on 2022-08-23, and primary completion is recorded as 2023-12-04. The sponsor is The Miriam Hospital. The phase is listed as NA.

The allocation is randomized, the model is parallel, and masking is listed as none. The comparison is between a behavioral Internet program and an informational newsletter condition. The Internet program was designed to increase physical activity and was described as a 12-week intervention. The newsletter condition involved 6 newsletters delivered every other week during the 3-month program. The record does not report further details about sequence generation, concealment of allocation, or whether outcome assessors were masked.

The study summary describes a planned randomization of 50 cancer survivors. The enrollment field records 46. The primary-outcome arm summaries each list 22 participants. The registry record does not explain how enrollment, randomization, and the numbers contributing to the primary endpoint relate to one another, so these figures should be read in their specific contexts rather than treated as interchangeable counts.

The primary endpoint covers change in moderate-to-vigorous physical activity from baseline to 3 months, assessed with Actigraph accelerometers. The registry lists additional outcomes for fatigue, health-related quality of life, psychological distress, and fear of cancer recurrence. Numerical results are posted for fatigue, general health on the SF-36, and psychological distress on the BSI-18. Although fear of recurrence appears in the secondary-outcome list, its numerical result is not reported in the registry record. Results for engagement and satisfaction, which are mentioned in the study summary, are also not reported in the registry record.

The record does not report the original sample-size justification, the planned statistical analysis, interim analyses, or a detailed analysis population. These omissions limit assessment of whether the posted analyses follow the original design and how all randomized participants were handled.

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 Change in Physical Activity, measured over baseline to 3 months.

The primary endpoint is change in physical activity from baseline to 3 months, expressed as minutes per week of moderate-to-vigorous intensity activity. The record says the measure was assessed using Actigraph accelerometers and defines a positive change as an increase in activity. Each arm’s posted value is a mean change, accompanied by a standard deviation describing variation among the recorded changes.

Physical activity is the central behavioral outcome named in the study title and summary. Comparing change from baseline gives a way to describe how activity levels shifted over the study period within each arm and how the average shifts differed between arms. The randomized comparison is relevant to the intervention question because the two groups were assigned to different program conditions. However, the registry record does not report enough analysis detail to determine whether the comparison was adjusted for baseline values or other factors.

The Internet-program arm had a mean change of 49.3 minutes per week, and the newsletter arm had a mean change of 15.1 minutes per week. Both means are positive, consistent with increases under the endpoint’s stated direction. The unadjusted mean difference, expressed as newsletter minus Internet program, is -34.2 minutes per week. This is a summary of the posted group results, not a complete account of individual participant trajectories or of the intervention’s effect under every possible analysis.

Engagement and program satisfaction are also described as primary aims in the study summary, but their measures and numerical findings are not reported in the registry record. The quantitative comparison therefore concerns the posted physical-activity change outcome.

7. Results Posted in the Registry

• Informational Newsletter Condition: mean 15.10 versus 49.30 on control; difference -34.20 (95% CI -90.68 to 22.28), standardized effect d = -0.36; z-test p = 0.235.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Fatigue Measured Via the Brief Fatigue Inventory (BFI)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Informational Newsletter Condition: mean -0.38 versus -0.32 on control; difference -0.06 (95% CI -1.21 to 1.09), standardized effect d = -0.03; z-test p = 0.918.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Informational Newsletter Condition and the control. The interval gives the range of effects that remain compatible with the data.

Health-related Quality of Life (General Health Subscale) Measured Via the SF-36

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Informational Newsletter Condition: mean 3.64 versus 2.05 on control; difference 1.59 (95% CI -5.02 to 8.20), standardized effect d = 0.14; z-test p = 0.637.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Informational Newsletter Condition and the control. The interval gives the range of effects that remain compatible with the data.

Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Informational Newsletter Condition: mean 0.50 versus 0.10 on control; difference 0.40 (95% CI -4.28 to 5.08), standardized effect d = 0.05; z-test p = 0.867.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Informational Newsletter Condition and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover changes in fatigue, general health-related quality of life, and psychological distress from baseline to 3 months. The registry record also names fear of recurrence as a secondary outcome, but a numerical result for it is not reported. Across the three secondary outcomes with posted numerical summaries, the recalculated mean differences are small relative to the uncertainty expressed by their confidence intervals, and each interval includes zero. These summaries therefore do not provide a precise separation between the arms on those measures.

The secondary outcomes add context to the primary physical-activity comparison by showing whether the posted results suggest a consistent pattern across related areas of health and well-being. They do not independently validate the primary result, and they should not be combined informally into a single overall conclusion. Each outcome measures a different construct and uses its own scale. The registry does not report a common threshold for a meaningful change across these measures.

In general, examining multiple outcomes creates more opportunities for chance findings. If each outcome is interpreted as a separate test without accounting for the full set, the overall chance of at least one apparently unusual result can increase. The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or which secondary comparisons were prespecified. This makes the secondary comparisons less persuasive as confirmatory evidence than a single prespecified primary comparison.

The registry lists no reported analyses for the secondary outcomes beyond the posted summaries. The secondary results are best read as descriptive and exploratory, with attention to both the estimated direction and the uncertainty. They do not settle whether the study conditions differ on these measures, and the record does not report enough detail to assess the effects of missing data or any adjusted analyses.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Fatigue Measured Via the Brief Fatigue Inventory (BFI)
• Health-related Quality of Life (General Health Subscale) Measured Via the SF-36
• Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)
• Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a measured quantity that can take a range of values. The registry reports means and standard deviations for change in minutes per week. A mean describes the average change in an arm. A standard deviation describes how spread out participant-level changes are around that mean; it is not a confidence interval and does not describe the precision of the estimated mean by itself.

The comparison is a difference between two arm means. The posted estimate is -34.2 minutes per week, expressed as newsletter minus Internet program. The sign depends on this ordering: a negative value means the newsletter arm’s reported mean change is lower than the Internet-program arm’s reported mean change. Reversing the order would reverse the sign without changing the underlying separation or the statistical evidence. The two means being compared are 15.1 and 49.3 minutes per week, respectively.

The comparison values are unadjusted recalculations from the posted summary statistics. A recalculated unadjusted comparison uses the reported group summaries and does not account for covariates or other adjustments. The registry record does not report an adjusted primary analysis, so the recalculated comparison should not be mistaken for a fully documented sponsor analysis. The record’s discrepancy indicator is false; there is no listed discrepancy that would make a sponsor analysis take precedence over the recalculation.

What does a confidence interval represent?

In general, a confidence interval describes the sampling uncertainty around an estimated quantity under the statistical method used. It identifies a range of values that are reasonably compatible with the observed data and method. It is not a guarantee that the true value lies in the interval, nor does it assign a probability to each value after the data have been observed. For the primary mean difference, the interval runs from -90.68 to 22.28 minutes per week. Because the interval includes zero, the data do not clearly distinguish a difference in one direction from no difference or a difference in the other direction.

What does the p-value add?

In general, a p-value measures how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the test assumptions were correct. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. The posted unadjusted p-value for the primary comparison is 0.235. It should be read alongside the estimate and confidence interval, rather than as a stand-alone decision or a measure of whether the intervention is beneficial.

Why does variability matter?

In general, greater variability makes group means less precisely estimated when other design features are held fixed. Here, the primary-outcome standard deviations are 90.5 and 100.4 minutes per week, while the arm means are 49.3 and 15.1. This spread means participant changes differ substantially around the group averages. A mean is a useful summary, but it does not show the distribution’s shape, whether there are influential observations, or how many participants had increases versus decreases. Such details are not reported in the registry record.

The comparison uses a mean difference, which retains the outcome’s original units. A standardized effect size is also listed as -0.358. In general, standardization expresses a difference relative to a measure of spread, which can help describe magnitude on a scale without the outcome’s original units. It does not replace the original-unit estimate, and it does not establish clinical importance. The record does not report a threshold for interpreting a meaningful change in weekly activity.

What is not documented about the analysis?

The registry record does not report the trial’s original statistical analysis plan, covariate adjustment, assumptions checks, or handling of missing outcome data. It also does not report interim analyses or a detailed definition of the analysis population. These details matter because different analysis choices can affect an estimate’s interpretation and precision. Without them, the posted summary supports a descriptive, unadjusted reading but not a reconstruction of the complete planned analysis.

The randomized parallel design defines the intended comparison between assigned conditions. Randomization is generally used to make groups comparable in expectation, but it does not guarantee that every realized sample is balanced on every characteristic. The registry record does not provide baseline characteristics or details about adherence to assignment. Consequently, the posted endpoint summaries do not show whether the groups were comparable on measured or unmeasured factors after enrollment or whether participants received the interventions as intended.

11. Confidence Intervals and Precision

The primary mean difference is -34.2 minutes per week, with a confidence interval from -90.68 to 22.28. The interval is wide enough to include a substantial difference favoring either ordering of the two arm means, as well as zero. This means the point estimate alone gives an incomplete picture: the range of values compatible with the posted summary is broad, and the direction of the difference is not determined precisely.

In general, confidence-interval width reflects the precision of an estimate under the method used. More variability and fewer observations tend to reduce precision, while other design features and analytic choices also matter. The primary arm summaries list 22 participants each, and the standard deviations are 90.5 and 100.4 minutes per week. These registry entries help contextualize the interval, but the registry record does not report enough detail to assess every feature of the analysis or the effect of missing observations.

The interval includes zero, and the unadjusted p-value is 0.235. These are two ways of expressing the same general uncertainty about whether the mean difference is distinguishable from zero under the unadjusted calculation. Neither means that the groups are proven equivalent. An equivalence conclusion would require an explicit margin for a negligible difference and an analysis designed to assess that margin; such a margin or analysis is not reported in the registry record.

The confidence interval also concerns the difference in group means, not the range of individual changes. Individual participant outcomes may vary more widely than the interval suggests. The group standard deviations describe variation among observations, whereas the confidence interval describes uncertainty about the estimated between-arm mean difference. Keeping those two kinds of spread separate is important when reading the result.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants or total events. They are illustrations based on the observed effect rather than the original trial’s design assumptions. The registry record lists the planning assumptions as a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. The original sample-size assumptions for the trial are not reported in the registry record.

For the primary outcome, planning for 100% of the observed effect gives 123 participants per arm for 80% power and 165 participants per arm for 90% power. Planning for 75% of the observed effect gives 218 participants per arm for 80% power and 292 participants per arm for 90% power. Planning for 50% of the observed effect gives 491 participants per arm for 80% power and 657 participants per arm for 90% power. These scenarios illustrate how the assumed effect size changes the planning requirement.

In general, power is the chance that a study with a specified design and true effect will reject the null hypothesis using the chosen test and significance level. The 80% and 90% columns describe two different planning targets: the latter aims for a greater chance of detecting the assumed effect, which generally requires more participants. Smaller effects are harder to distinguish from random variation, so planning for a smaller fraction of the observed effect requires more participants per arm.

These figures are planning illustrations, not observed power. They use the observed effect as an input and should not be read as evidence that the completed trial had a particular chance of finding a result. The registry record does not report the trial’s original power calculation or the assumptions used to choose its planned enrollment.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -34.200; pooled standard deviation σ = 95.578.
2. n = 2 × (1.96 + 0.842)² × 95.578² / -34.200² = 122.6, rounded up to 123 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -34.2                      # observed difference in means
sigma <- 95.5782663579959                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5376293)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 123 (80% power), 165 (90% power)
 75% of observed effect: n per arm = 218 (80% power), 292 (90% power)
 50% of observed effect: n per arm = 491 (80% power), 657 (90% power)
power.t.test: 123.6 
Simulated power at n = 123 per arm: 0.802 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes or comparisons are examined. In general, testing many hypotheses without accounting for the number of tests can increase the chance of at least one apparently positive result arising by chance. This study summary identifies a primary physical-activity outcome and several additional outcomes, including engagement and satisfaction aims. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a prespecified approach for interpreting the group of secondary outcomes. Therefore, unadjusted secondary comparisons should be treated cautiously and should not be regarded as independent confirmatory findings.

The record lists four secondary outcomes, but numerical results are posted for fatigue, general health on the SF-36, and psychological distress on the BSI-18. A numerical result for fear of recurrence is not reported in the registry record. Engagement and program satisfaction are named in the study summary, but their numerical findings are also not reported. The record does not clarify whether those outcomes were collected, analyzed, or omitted from the posted results.

Missing-data handling is not reported in the registry record. The primary endpoint summaries list 22 participants per arm, while secondary summaries list 21 in one arm and 22 in the other for each of the three posted measures. The record does not explain why the analysis counts differ across outcomes, whether any measurements were missing, or how any missing observations were handled. It does not report whether the analysis used complete cases, imputation, or another method.

The analysis population is also not specified. The randomized allocation is recorded, but the record does not say whether results use all randomized participants, participants with available measurements, or another defined population. No detailed protocol deviations or adherence summaries are reported. These omissions prevent a full assessment of whether the analyses preserve the benefits of randomization and how robust the estimates are to missing observations.

Interim analyses and the original statistical plan are not reported in the registry record. Without these details, the posted unadjusted comparisons can be described, but it is not possible to establish from the registry record whether all analysis choices were prespecified or how the full outcome family was intended to be interpreted.

15. 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.

The adverse-event entries report zero serious adverse events and zero other adverse events in both arms. Each arm’s safety entry lists 23 participants at risk for serious events and 23 at risk for other events. The entries also report zero deaths in each arm. No serious-event terms are listed.

These figures describe the adverse-event counts recorded in the registry. They are not the same counts as those listed for the primary outcome, and the record does not explain why the at-risk counts differ from the primary-outcome counts. The registry also does not report the methods used to collect or classify adverse events, the observation period for safety reporting, or whether all participants were assessed in the same way.

Zero recorded events should be read as zero events reported in these entries, not as proof that no event occurred outside the recorded data or that the interventions carry no risk. The absence of event terms also means there are no listed serious-event categories to interpret. These safety entries alone cannot establish a comparative safety profile.

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

The posted primary results show positive average changes in weekly moderate-to-vigorous physical activity in both arms. The mean change was 49.3 minutes per week in the behavioral Internet program arm and 15.1 minutes per week in the informational newsletter arm. The unadjusted difference, expressed as newsletter minus Internet program, was -34.2 minutes per week. Its confidence interval, from -90.68 to 22.28, includes zero and allows for uncertainty in either direction.

That finding does not establish that the two arms are equivalent. A non-significant unadjusted comparison is not proof of no difference, particularly when the interval remains broad. Nor does the point estimate alone establish that the Internet program caused the difference. The registry record does not report an adjusted analysis, missing-data method, analysis population, or detailed adherence information that would support a fuller evaluation of the comparison.

The result concerns an average change in one measured behavior over the baseline-to-3-month interval. It does not describe every participant’s experience, long-term changes, or whether an observed change is important to participants. A threshold for meaningful change is not reported in the registry record. The posted outcome also does not answer the study’s engagement and satisfaction aims, for which numerical results are not reported.

The secondary outcomes are not precise enough in the posted comparisons to provide a clear, consistent distinction between arms. They also involve multiple measures, and the record does not report a multiplicity strategy. These results should therefore be read as exploratory and kept separate from the primary outcome.

In short, the registry gives a descriptive account of group-level changes and an uncertain unadjusted between-arm comparison. It does not support a definitive conclusion about the presence or absence of a meaningful difference, and it does not establish effects beyond the outcomes and follow-up interval recorded.

17. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison should be read through its estimate and uncertainty together. The primary mean changes are numerically separated, but the confidence interval for their difference includes zero and spans values in both directions. Focusing only on the two arm means or only on the p-value would leave out important information about the precision of the comparison.

The outcome is expressed in minutes per week, which keeps the result connected to the physical-activity measure used in the study. The standard deviations also show that changes varied considerably among participants relative to the group means. This is a useful reminder that a group average does not describe the full spread of individual outcomes.

The record also demonstrates the importance of distinguishing planning illustrations from the completed trial’s design. The sample-size figures use an observed effect and stated planning assumptions, while the original sample-size justification is not reported. Those illustrations can show how planning changes with the assumed effect and desired power, but they cannot tell readers what assumptions guided the trial’s original enrollment target.

Finally, the differences among enrollment, outcome, and safety counts, along with the absence of reported missing-data and multiplicity procedures, affect how confidently the results can be interpreted. Clear reporting of analysis populations, prespecified methods, and all intended outcomes would help readers assess the limits of the estimates. These considerations apply even when a registry contains numerical summaries for the main comparison.

18. 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.

Several limitations specific to the registry record constrain interpretation. The primary outcome is reported as arm means and standard deviations, with an unadjusted mean difference and confidence interval, but a detailed sponsor analysis is not reported. The record does not state whether baseline values or other variables were included in an adjusted model, or whether the assumptions of the analysis were assessed.

The enrollment field records 46, while the study summary describes a plan to randomize 50. The primary outcome lists 22 participants in each arm, and the adverse-event entries list 23 at risk in each arm. The registry record does not reconcile these counts or describe the populations underlying them. Secondary-outcome counts also vary by outcome and arm. Missing-data methods and reasons for unavailable measurements are not reported.

The record does not report the original sample-size calculation, so the planning illustrations based on the observed effect cannot be used to reconstruct the study’s design rationale. It also does not report an analysis plan, interim analyses, or a multiplicity strategy. These omissions make it difficult to judge whether the posted comparisons match prespecified analyses or how the collection of outcomes was intended to be interpreted.

Numerical findings are not reported for engagement, satisfaction, or fear of recurrence, despite their appearance in the study description or outcome list. The registry record also provides no threshold for a meaningful change in physical activity. Further limitations include the absence of details on intervention adherence, participant characteristics, and follow-up beyond the stated 3-month endpoint. These details are not reported in the registry record and should not be inferred.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Be-Active Study - Increasing Physical Activity in Cancer Survivors — NCT05376293.
• Registry record last updated 2025-04-24; status last verified 2025-01.
• Results first posted 2025-04-24.
• 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.

22. Record Summary

NCT05376293 is a completed randomized, parallel study comparing a 12-week behavioral Internet program with an informational newsletter condition in cancer survivors. The primary endpoint is change in moderate-to-vigorous physical activity from baseline to 3 months, measured in minutes per week with Actigraph accelerometers.

The Internet-program arm had a mean change of 49.3 minutes per week, and the newsletter arm had a mean change of 15.1 minutes per week. The unadjusted difference, newsletter minus Internet program, was -34.2 minutes per week, with a confidence interval from -90.68 to 22.28 and an unadjusted p-value of 0.235. The interval includes zero, leaving substantial uncertainty about the between-arm difference.

Numerical secondary results are posted for fatigue, general health-related quality of life, and psychological distress. The registry record does not report numerical findings for fear of recurrence, engagement, or satisfaction. The original analysis plan, missing-data methods, and sample-size justification are not reported in the registry record.