Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy (NCT03860961), a randomized na study. The primary outcome is Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment.

2. Clinical Question

3. Trial Design

The registry describes a completed, randomized, parallel-group trial of survivorship care planning for prostate cancer survivors receiving radiation therapy and androgen deprivation therapy. Masking is listed as none. The record reports enrollment of 550 and lists NRG Oncology as sponsor. The registry dates are 2019-07-26 for study start and 2024-11-14 for primary completion. The record does not report the original sample-size justification or the full details of the randomization procedure.

The two groups differed in the timing and content of care-plan communication. In Arm A, practices reviewed a survivorship care plan with patients during the last week of radiation therapy and sent it to the primary care physician. In Arm B, practices reviewed a treatment plan and sent it to the primary care physician at the beginning of radiation therapy, then also reviewed the survivorship care plan as in Arm A. Thus the comparison is an added earlier planning step alongside the later survivorship care plan, rather than a comparison with no care planning.

The primary outcome was assessed during the second year after radiation treatment. The registry gives analysis counts of 257 in Arm A and 256 in Arm B for that outcome, with 160 and 157 participants, respectively, meeting the outcome. These outcome-specific counts need not equal total enrollment: the registry defines the primary outcome population as eligible participants from randomized practices with the necessary data. How participants without the necessary data were handled in the analysis is not reported in the registry record.

The registry also lists secondary outcomes for cardiovascular risk score, coordination of care, and satisfaction with care, assessed two years after radiation therapy. These outcomes have their own analysis counts, so their analyzed populations differ from the primary outcome population. The registry does not report the randomization unit in the design fields, allocation concealment details, a complete statistical analysis plan, or the original design assumptions.

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.

Before assignment: Of 833 participants screened at randomized practices, 550 were enrolled.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Eligible participants from randomized practices with necessary data for this outcome measure.

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.

Population: Enrolled participants

6. Primary Endpoint

The registry lists the primary outcome as Number of Patients Adhering to Cardiovascular Follow-up Recommendations in the Second Year After Radiation Treatment, measured over During the second year (13 to 24 months) after completion of approximately 4-9 weeks of radiation therapy..

The primary endpoint is the number of participants adhering to cardiovascular follow-up recommendations during the second year, defined as 13 to 24 months after radiation therapy. A participant counted as meeting the endpoint only if the medical-record review indicated all three specified elements: a visit with a primary care provider or cardiologist, fasting blood glucose testing, and fasting cholesterol testing. The records reviewed were from the participant’s primary care provider and cardiologist.

The registry states that these criteria were interpreted from recommendations published jointly by the American Heart Association, American Cancer Society, and American Urological Association. The endpoint therefore represents a combined measure of whether the listed follow-up activities occurred; it does not separately report the frequency of each activity as the primary outcome. It is a binary participant-level outcome, summarized in the record as counts and compared between arms.

General statistical context: a combined adherence endpoint can capture completion of a defined package of follow-up actions, but its interpretation depends on the criteria and observation period. A participant who misses any one of the required elements does not meet the full combined definition, even if the other elements occurred. The registry does not report whether each component was analyzed as a separate primary endpoint or how missing documentation was classified.

7. Results Posted in the Registry

• Arm B (Enhanced Survivorship Care Plan): 61.3% (157/256) versus 62.3% (160/257) on control; risk difference -0.9 percentage points (95% CI -9.3 to 7.5), risk ratio 0.99 (0.86–1.13); unadjusted two-proportion z-test p = 0.829.

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.

Calculated Cardiovascular (CVD) Risk Score at Two Years

• 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:
  • Arm B (Enhanced Survivorship Care Plan): mean 0.26 versus 0.26 on control; difference -0.00 (95% CI -0.03 to 0.03), standardized effect d = -0.01; z-test p = 0.946.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm B (Enhanced Survivorship Care Plan) and the control. The interval gives the range of effects that remain compatible with the data.

Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)

• 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:
  • Arm B (Enhanced Survivorship Care Plan): mean 5.46 versus 5.29 on control; difference 0.17 (95% CI -0.02 to 0.36), standardized effect d = 0.18; z-test p = 0.079.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm B (Enhanced Survivorship Care Plan) and the control. The interval gives the range of effects that remain compatible with the data.

Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)

• 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:
  • Arm B (Enhanced Survivorship Care Plan): mean 82.68 versus 81.96 on control; difference 0.72 (95% CI -1.39 to 2.83), standardized effect d = 0.07; z-test p = 0.503.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm B (Enhanced Survivorship Care Plan) and the control. The interval gives the range of effects that remain compatible with the data.

Across the three posted secondary outcomes, the recalculated comparisons do not show a precise separation between the two arms: each confidence interval includes zero. The registry’s reported mixed models test for cardiovascular risk score has p = 0.561, while no sponsor-reported analyses are listed for coordination of care or patient satisfaction. The overall pattern should be viewed alongside the primary result, which likewise has an unadjusted interval spanning zero and a sponsor-reported test that does not indicate a clear separation under its stated method.

These secondary measures address different aspects of follow-up: a calculated cardiovascular risk score, coordination of care with a primary care provider or cardiologist, and satisfaction with care. They can add context about care processes and reported experience, but they are not interchangeable with the primary adherence endpoint. Nor do the secondary outcomes explain the primary result or identify which element of care planning might account for it.

General statistical context: when several outcomes are examined, the chance of at least one apparently notable finding due to random variation can increase if each is interpreted without accounting for the full set of tests. This is why isolated unadjusted secondary results generally carry less confirmatory weight than a prespecified primary analysis. The registry does not report a multiplicity adjustment or a hierarchy defining how secondary outcomes should be interpreted. In addition, the outcome-specific analysis counts differ, and detailed missing-data handling is not reported. The secondary findings are therefore best treated as complementary and exploratory evidence rather than independent confirmation of an effect.

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

• Calculated Cardiovascular (CVD) Risk Score at Two Years
• Components of the Primary Care Index (CPCI) Coordination of Care Subscale Score With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)
• Patient Satisfaction With Care With Respect to the PCP (or Cardiologist if Patient Does Not Have a PCP)

9. Statistical Interpretation

10. Statistical Methods Explained

General statistical context: the primary endpoint is binary at the participant level: each participant either met all three follow-up criteria or did not meet the combined definition. Counts are therefore presented as participants meeting the outcome out of the participants analyzed in each arm. The arm-level counts are 160 of 257 for Arm A and 157 of 256 for Arm B. The record also gives arm-level outcome proportions as 0.623 and 0.613, respectively.

What does a risk difference express?

General statistical context: a risk difference compares the outcome proportions in two groups by subtracting one proportion from the other. Here, the comparison is Arm B relative to Arm A, and the recalculated estimate is -0.009. A negative estimate means the observed proportion meeting the endpoint was lower in Arm B than in Arm A under this comparison. The estimate is an absolute difference in proportions, not a relative change. It is not an adjusted estimate and should be understood as a simple comparison of the posted group summaries.

How does the registry’s primary test differ?

The registry reports a corrected chi-squared test for superiority, with p = 0.924. A chi-squared test assesses whether the observed group counts are compatible with a null hypothesis of no association between group and outcome, under its statistical assumptions. The word “corrected” is part of the method description in the record; details of the correction are not reported there. The recalculated unadjusted p-value is 0.829. It comes from a separate simple comparison and is not a reproduction of the sponsor’s reported test. The registry’s report does not provide a confidence interval for the sponsor’s test result.

What does an unadjusted calculation mean?

General statistical context: an unadjusted comparison uses the posted group summaries without accounting for other variables or design features in a fitted model. Such a calculation can be useful for understanding the approximate direction and scale of the observed contrast, but it does not necessarily reproduce an analysis that accounts for design, clustering, covariates, or other model features. The registry does not report enough detail to determine whether the sponsor’s primary test incorporated additional design features beyond the stated corrected chi-squared method. The record lists eligible participants from randomized practices, but does not give the randomization unit in the design fields.

Why use confidence intervals alongside tests?

General statistical context: a confidence interval indicates the range of effect estimates that are reasonably compatible with the observed data under a particular method and its assumptions. The primary risk-difference interval runs from -0.093 to 0.075. It includes zero and spans values on both sides of zero. The interval is more informative than a thresholded interpretation of a p-value because it communicates both direction and precision. It does not mean that every value within the interval is equally likely, nor does it incorporate uncertainty from unreported design or missing-data choices.

How should continuous outcomes be read?

The secondary cardiovascular risk score, coordination-of-care score, and satisfaction score are reported as means with standard deviations. General statistical context: a mean summarizes the average score in a group, while a standard deviation describes the spread of individual scores around that average. A mean difference compares those group averages. The recalculated mean differences and confidence intervals use the posted means, standard deviations, and group counts. Their interpretation depends on the scale and its measurement properties, which are not described in detail in the registry record.

For cardiovascular risk score, the registry reports a mixed models analysis with p = 0.561. A mixed model can account for structured or correlated observations through modeled effects, but the particular model specification, covariance structure, and covariates are not reported in the registry record. No sponsor-reported analysis is listed for the coordination-of-care or satisfaction outcomes. Their recalculated comparisons are unadjusted summaries, not substitutes for a missing model specification.

What is not specified?

The registry does not report the complete statistical analysis plan, the original sample-size justification, the method for handling missing data, or whether analyses followed an intention-to-treat principle. It also does not report interim analyses, prespecified multiplicity control, or detailed adjustment variables. These omissions limit how fully the posted analyses can be independently reproduced or evaluated. General statistical context: inference is conditional on both the observed data and the analysis choices. When choices about exclusions, missing outcomes, clustering, and multiple outcomes are not described, readers cannot assess their influence from the summary statistics alone.

11. Confidence Intervals and Precision

The recalculated primary risk difference is -0.009, and its 95% confidence interval extends from -0.093 to 0.075. Because the interval includes zero, the posted summaries are compatible with no difference under this unadjusted comparison. They are also compatible with values below and above zero, so the direction of the underlying contrast is not pinned down precisely. The interval’s endpoints should be read on the risk-difference scale, not as relative effects.

General statistical context: a confidence interval is a method-based range that reflects sampling uncertainty under the assumptions used to calculate it. It is not a guarantee that the true effect lies within the interval, and it does not account for sources of uncertainty that were not modeled or reported. Its width is important: an interval can include zero because the estimate is near zero, because the data are imprecise, or both. The group counts and interval should therefore be considered together.

The registry’s sponsor-reported primary analysis gives a p-value but no effect estimate or confidence interval in the posted results. The recalculated interval is based on the simple unadjusted risk difference and should not be attributed to that corrected chi-squared test. The registry does not report an equivalence boundary or a threshold for a difference considered important, so the interval cannot establish equivalence or clinical importance on its own.

For the continuous secondary outcomes, the recalculated confidence intervals also include zero. These intervals describe uncertainty in the mean differences under the simple calculations, not uncertainty under an unreported sponsor model. More complete interpretation would require the scale properties and analysis details, which are not reported in the registry record.

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, for the binary primary outcome. The record’s planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. These are planning illustrations based on the observed effect, not the trial’s original design assumptions; those original assumptions are not reported in the registry record.

The 80% power column gives the planned number of participants per arm under which a study would have an 80% chance of detecting the specified effect, if the planning assumptions and effect were correct. The 90% power column uses a higher target chance of detecting that effect and consequently requires more participants per arm. These are design calculations, not descriptions of the number enrolled or analyzed in this trial.

The rows express planning for 100%, 75%, and 50% of the observed effect. A smaller effect is harder to distinguish from random variation under the same assumptions, so planning for a smaller effect requires more participants. The values should be read as conditional illustrations: if the effect used for planning is different from the effect that would occur in a future study, the resulting operating characteristics would also differ.

This is not observed power. It does not tell whether the completed trial was adequately powered after the results were known, and it cannot be used to reinterpret a nonsignificant result as proof of no effect. The sample-size display is a sensitivity illustration built from the posted observed effect and specified calculation assumptions, rather than evidence about the trial’s original planning process.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.623; treatment proportion p₁ = 0.613; average p̄ = 0.618.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6872 = 1.3468.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6871 = 0.5783.
4. n = (1.3468 + 0.5783)² / (-0.0093)² = 42,970.9, rounded up to 42,971 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
p0 <- 0.622568093385214                          # control proportion
p1 <- 0.61328125                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(3860961)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 42,971 (80% power), 57,526 (90% power)
 75% of observed effect: n per arm = 76,305 (80% power), 102,150 (90% power)
 50% of observed effect: n per arm = 171,485 (80% power), 229,569 (90% power)
power.prop.test: 42970.9 
Simulated power at n = 42,971 per arm: 0.798 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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. Analyses Reported by the Sponsor

The registry’s sponsor-reported primary analysis is a corrected chi-squared test for superiority, with p = 0.924. The recalculated comparison uses the posted primary-outcome counts to obtain an unadjusted risk difference of -0.009, a 95% confidence interval from -0.093 to 0.075, and an unadjusted p-value of 0.829. These values are from different analyses and should be kept distinct: the recalculation is not a replacement or exact replication of the sponsor’s test.

The registry does not provide the sponsor analysis’s effect estimate, confidence interval, or details of the correction, so its magnitude and precision cannot be compared directly with the recalculated risk difference. The record does not flag a discrepancy between the posted calculation and sponsor result. When a discrepancy is flagged, the sponsor’s own analysis takes precedence; no such flag is recorded for this result.

For the cardiovascular risk score, the record reports a mixed models analysis with p = 0.561. The registry does not list sponsor-reported analyses for the coordination-of-care or satisfaction outcomes. The simple recalculations for those outcomes should therefore be read as descriptive comparisons from the posted summaries, not as estimates from a sponsor-reported model.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary outcome and lists multiple secondary outcomes, with six outcome measures and two analyses recorded overall. It does not report whether a multiplicity strategy was prespecified, whether any adjustment was applied across outcomes, or whether a hierarchy governed interpretation. Without that information, the secondary analyses should not be treated as if they each carried the same confirmatory status as the primary analysis.

Missing-data handling is also not reported in detail. For the primary outcome, the eligible population is described as participants from randomized practices with necessary data. The registry gives 257 analyzed participants in Arm A and 256 in Arm B, but does not explain the reasons other enrolled or randomized participants may not appear in that outcome analysis. It does not say how incomplete medical records, absent laboratory documentation, or other missing information were classified.

The analysis populations for secondary outcomes differ from those for the primary endpoint. The record provides separate counts for each secondary measure, but does not explain the inclusion rules or missingness patterns that produced those counts. It does not report imputation methods, sensitivity analyses for missing outcomes, or whether the primary analysis followed an intention-to-treat principle.

The record describes randomization and a parallel design, and the primary outcome population is drawn from randomized practices. However, the design fields do not specify the randomization unit or provide a detailed account of whether analyses accounted for possible clustering within practices. The reported primary test is a corrected chi-squared test, but the correction details are not given. The record also does not report interim analyses or the full statistical analysis plan. These gaps do not establish that the analysis was inappropriate; they limit what can be verified from the registry results alone.

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

The posted primary results describe similar observed counts of participants meeting the defined cardiovascular follow-up criteria in the two arms: 160 of 257 in Arm A and 157 of 256 in Arm B. The recalculated risk difference is close to zero, but its confidence interval includes values on both sides of zero. The sponsor-reported corrected chi-squared test gives p = 0.924. Together, these results do not show a clear separation between the arms under the reported analyses.

That statistical interpretation is narrower than saying the care approaches are equivalent. An absence of a statistically clear difference is not proof that the true difference is exactly zero. The record does not report an equivalence or noninferiority design, a margin for judging acceptable differences, or a sponsor-reported interval for the primary effect. The recalculated interval also leaves uncertainty about the possible direction and size of the contrast.

The endpoint is a specific composite of documented follow-up actions within a defined period. It does not cover every aspect of cardiovascular health, survivorship care, or patient experience. The trial’s care-planning contrast concerns an earlier treatment-plan review and communication in addition to a survivorship care plan; it is not a comparison of all possible care-coordination strategies. The registry results do not establish which parts of the planning process influenced care.

Secondary outcomes provide additional measures but have different analysis counts and incomplete reporting of sponsor analyses and multiplicity procedures. They should not be used to make a broader claim than their measures support. General statistical context: estimates describe observed data under an analysis method; they do not determine individual outcomes or provide medical advice. The registry record alone also cannot resolve the influence of unreported missing-data choices, practice-level structure, or other analysis details.

17. Why This Trial Matters Statistically

This trial raises a practical statistical question about how an added planning step is evaluated when both groups receive a survivorship care plan. The primary contrast is not planning versus no planning; it is the established care-plan process versus that process plus an earlier treatment-plan review and communication with the primary care physician. Defining the contrast precisely is essential for interpreting what an estimated difference can represent.

The endpoint also illustrates the distinction between a care process and a clinical outcome. It counts participants who met all specified cardiovascular follow-up criteria during a defined period. This yields an interpretable measure of adherence to a recommendation-based package, but it does not itself measure cardiovascular events or establish the quality of each encounter. Statistical interpretation should remain aligned with what was actually recorded.

The registry includes a sponsor-reported primary test and enough group summaries for a simple unadjusted effect estimate and interval. Seeing both makes the difference between a test result and an effect estimate explicit: the test addresses evidence against a null hypothesis, while the risk difference and its interval describe the scale and uncertainty of the contrast. The two analyses use different methods, so their results should not be conflated.

Finally, the record demonstrates why transparency about analysis populations, missing data, multiplicity, and practice-level design features matters. Such information supports reproducibility and helps readers judge how robust a result is to reasonable analytic choices. Where those details are not reported, conclusions should remain tied to the posted estimates and avoid claims that extend beyond them.

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.

The registry does not report the original sample-size justification, full statistical analysis plan, or the detailed basis for the corrected chi-squared test. The sample-size illustrations are based on the observed effect and cannot show what assumptions guided the completed trial. The record also does not report whether interim analyses occurred or how any were handled.

The primary outcome analysis includes only eligible participants with necessary data, but detailed reasons for missing data or exclusion are not reported. There is no description of imputation, sensitivity analyses, or the exact analysis population principle. Because outcome counts differ across the primary and secondary measures, the populations represented by those outcomes may differ as well.

The trial is described as involving randomized practices, yet the design fields do not specify the randomization unit or whether the reported analyses accounted for correlation among participants treated at the same practice. The corrected chi-squared method is named, but its correction details are not given. These limitations make it difficult to assess whether the simple recalculations capture all relevant design features.

The registry reports three secondary outcomes but does not state how multiplicity was addressed. Sponsor-reported analysis results are absent for two of them. The secondary measures also have different scales and analysis counts, and scale interpretation details are not reported. Finally, the primary result is a defined adherence measure based on records; the registry does not provide component-specific primary analyses or details on how incomplete documentation was treated. These omissions constrain interpretation without demonstrating that the posted results are invalid.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Increasing the Dose of Survivorship Care Planning in Improving Care and Outcomes in Prostate Cancer Survivors Receiving Androgen Deprivation Therapy — NCT03860961.
• Registry record last updated 2026-10-05; status last verified 2026-09.
• Results first posted 2025-11-03.
• 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.

22. Record Summary

NCT03860961 is a completed randomized, parallel-group trial sponsored by NRG Oncology. It enrolled 550 and compared a survivorship care plan reviewed during the last week of radiation therapy with an enhanced approach that added an earlier treatment-plan review and communication while retaining the survivorship care plan.

The primary outcome was adherence to all three specified cardiovascular follow-up recommendations during the second year after radiation treatment. The posted primary counts were 160 of 257 in Arm A and 157 of 256 in Arm B. The sponsor-reported corrected chi-squared test gave p = 0.924; a separate unadjusted recalculation estimated a risk difference of -0.009 with a 95% confidence interval from -0.093 to 0.075.

Secondary outcomes covered cardiovascular risk score, coordination of care, and satisfaction with care. Important details about the original design assumptions, missing-data handling, multiplicity, and some analysis methods are not reported in the registry record.