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Colorectal Cancer Screening Phase not stated Registry Results NCT04683744

Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation: Complete Statistical Analysis

This registry record describes interviews with patients and health-system stakeholders about cancer screening and healthcare decisions during the COVID-19 pandemic. The primary outcome concerns themes identified in patient interviews, but no numerical theme results or statistical analyses are reported in the registry record.

Trial start: 2021-01-11  ·  Enrollment: 82  ·  Sponsor: Indiana University
Scope of this record

This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.

1. Trial at a Glance

This page covers the registry results for Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation (NCT04683744), a registered phase not stated study. The primary outcome is Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic..

82
Enrollment
Phase not stated
n/a
Arms
In the primary outcome
n/a
Effect
No re-analysis shown
n/a
95% CI
See limitations
FeatureRegistry value
ClinicalTrials.gov identifierNCT04683744
PhasePhase not stated
ConditionColorectal Cancer Screening
AllocationNot Stated
Design modelNot Stated
MaskingNot Stated
Enrollment82
Arms in the primary outcomen/a
Lead sponsorIndiana University
Results postedYes

2. Clinical Question

Population

Patients receiving primary care at the study team’s affiliated health systems, along with healthcare-system leadership, providers, and staff. The patient interviews concerned people due for breast, cervical, colorectal, or lung cancer screening during April-July 2020. The registry describes 32 patients who completed screening in 2020 and 29 who had not completed the relevant screening test by their interview.

Intervention

Semi-structured interviews with patients and with health-system personnel. These interviews are the study activities recorded as interventions; they are not a treatment intended to change screening behavior.

Comparator

The record distinguishes patients who completed screening from patients who did not, and separately describes health-system leadership, providers, and staff. It does not describe a randomized or like-for-like control comparison, and allocation is not stated.

Primary question

What themes influenced patients’ decisions about cancer screening and other healthcare services, and what information did patients need to make healthcare decisions during the COVID-19 pandemic? The registry lists the primary outcome as the number of themes identified in patient interviews, but the numerical result is not reported in the registry record.

3. Trial Design

This completed study used semi-structured interviews to examine perspectives on cancer screening and healthcare during the COVID-19 pandemic. The registry lists two interview activities: one involving patients and one involving health-system personnel. The listed groups include healthcare-system leadership, providers, and staff, as well as patients receiving primary care at the study team’s affiliated health systems. The record reports enrollment of 82.

The primary outcome description concerns interviews with primary-care patients who were due for breast, cervical, colorectal, or lung cancer screening between April-July 2020. The interview guide explored understanding, attitudes, and beliefs about preventive healthcare during the pandemic, including perceived risk, barriers to preventive and other healthcare, and information needed for decision making. The registry describes 32 patients who completed screening in 2020 and 29 who had not completed the relevant screening test from April 2020 to the interview date. A separate group description lists 20 health-system leadership, providers, and staff.

This is not a randomized treatment comparison. The registry explicitly notes that allocation is not stated and that the arms are not a like-for-like control comparison. The screened and not-screened groups are categories of patients, not assigned intervention arms. The interviews gather stakeholder perspectives; the record does not describe an intervention being tested against a control condition.

The study start date is 2021-01-11, and the primary completion date is 2023-05-03. The status is COMPLETED. The primary outcome has a timeframe of 6 months. Further details about recruitment procedures, interview conduct, transcription, coding, or the timing of individual interviews are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: One patient that was consented, enrolled, and interviewed was removed from the study after review of data by PI and key research members concluded that the patient had undergone a diagnostic rather than screening procedure.

Overall Study

StageHealthcare System Leadership, Providers, and StaffNot Screened PatientsScreened Patients
STARTED202933
Interview #1202933
Interview #21100
COMPLETED202932
NOT COMPLETED001

Reasons for not completing this period:

ReasonHealthcare System Leadership, Providers, and StaffNot Screened PatientsScreened Patients
withdrawn (determined not eligible after enrollment)001

Analysis population for the primary outcome, as defined in the registry: The initial sample of 8 interviewees identified 12 additional stakeholders, allowing us to "snowball" our sample to complete interviews with 20 participants including primary care providers, nurses, medical assistants, quality and clinic managers, and cancer screening program managers.

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.

CharacteristicUnitNot Screened PatientsScreened PatientsHealth System ParticipantsTotal
Participants analysed29322081
Age, Continuousyears56.1 (SD 15.1)56.2 (SD 14.5)—56.1 (SD 14.7)
Sex/Gender, Customized: FemaleParticipants2423—47
Sex/Gender, Customized: MaleParticipants49—13
Sex/Gender, Customized: OtherParticipants10—1
Race/Ethnicity, Customized: WhiteParticipants1716—33
Race/Ethnicity, Customized: Black or African AmericanParticipants1113—24
Race/Ethnicity, Customized: OtherParticipants13—4
Race/Ethnicity, Customized: Hispanic/LatinoParticipants00—0
Living Situation: Never MarriedParticipants79—16
Living Situation: Married/Living with a PartnerParticipants1413—27
Living Situation: DivorcedParticipants34—7
Living Situation: SeparatedParticipants01—1
Living Situation: WidowedParticipants55—10
Highest Level of Education: Less than high school diplomaParticipants23—5
Highest Level of Education: High school graduate/GEDParticipants127—19
Highest Level of Education: Some college/technical or trade schoolParticipants710—17
Highest Level of Education: Associate degreeParticipants04—4
Highest Level of Education: Bachelor's degreeParticipants67—13
Highest Level of Education: Professional or graduate degreeParticipants21—3
Employment Status: Unemployed/retiredParticipants2116—37
Employment Status: Employed Full-timeParticipants69—15
Employment Status: Employed Part-timeParticipants26—8
Employment Status: UnknownParticipants01—1
Subjective Health Status: ExcellentParticipants11—2
Subjective Health Status: Very goodParticipants36—9
Subjective Health Status: GoodParticipants1416—30
Subjective Health Status: FairParticipants77—14
Subjective Health Status: PoorParticipants42—6
Subjective Income: Are comfortableParticipants715—22
Subjective Income: Have just enough to make ends meetParticipants1414—28
Subjective Income: Do NOT have enough to make ends meetParticipants73—10
Subjective Income: UnknownParticipants10—1
Difficulty Understanding Written Information: AlwaysParticipants20—2
Difficulty Understanding Written Information: OftenParticipants01—1
Difficulty Understanding Written Information: SometimesParticipants78—15
Difficulty Understanding Written Information: OccasionallyParticipants75—12
Difficulty Understanding Written Information: NeverParticipants1318—31
Confidence Filling Out Medical Forms: ExtremelyParticipants1521—36
Confidence Filling Out Medical Forms: Quite a bitParticipants55—10
Confidence Filling Out Medical Forms: SomewhatParticipants44—8
Confidence Filling Out Medical Forms: A little bitParticipants11—2
Confidence Filling Out Medical Forms: Not at allParticipants41—5
Have Help Reading Hospital Materials: AlwaysParticipants20—2
Have Help Reading Hospital Materials: OftenParticipants22—4
Have Help Reading Hospital Materials: SometimesParticipants44—8
Have Help Reading Hospital Materials: OccasionallyParticipants76—13
Have Help Reading Hospital Materials: NeverParticipants1420—34
Health System Roles: Leadership/AdministrationParticipants——99
Health System Roles: Provider (MD, DO, APP)Participants——55
Health System Roles: Clinical Support (MA, RN)Participants——66

6. Primary Endpoint

The registry lists the primary outcome as Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic., measured over 6 months.

ElementRegistry entry
Result typeNumber
Measure of spreadnot applicable
UnitThemes
Endpoint classificationnot reduced to a single comparison

The primary outcome is the number of themes identified in patient interviews concerning decisions to engage in cancer screening and other healthcare services, as well as information needed for healthcare decisions during the COVID-19 pandemic. Its unit is “Themes,” and the registry lists the parameter as NUMBER. The outcome description connects this measure to interviews with primary-care patients due for breast, cervical, colorectal, or lung cancer screening between April-July 2020.

In general, a theme count can describe the range of recurring topics found in qualitative material. It is not, by itself, a measure of how common a view is in a broader population, how strongly a factor affects a decision, or whether one approach changes behavior. Those interpretations would require appropriate definitions and analyses, which are not reported in the registry record. The record does not state how a theme was defined, whether themes could overlap, how many people coded the interviews, or how coding disagreements were resolved.

The outcome is relevant to the stated research question because the study seeks to identify factors patients said influenced healthcare decisions and information they considered necessary. However, the registry record does not report the number or names of themes, nor does it provide participant-level counts or quotations. As a result, the endpoint’s intended subject is clear, but its observed value and the evidence supporting its measurement cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

Reported as posted, not recalculated. Not a randomized comparison (allocation: not stated); arms are not a like-for-like control comparison. A result is recalculated only when the posted data support a clean two-arm comparison, so no result is shown beyond what the sponsor posted.

8. Statistical Interpretation

Clinical Biostats interpretation

The registry record describes a qualitative interview study, not a randomized trial estimating the effect of a screening intervention. Its central question is about patient and health-system perspectives on cancer screening and healthcare during the COVID-19 pandemic. The recorded primary outcome is a number of themes identified in patient interviews. The numerical result for that outcome is not reported in the registry record, so the magnitude and content of the findings cannot be interpreted from the record.

The record distinguishes patients who completed screening in 2020 from those who had not completed the relevant test by interview. That distinction may organize interview findings, but it does not establish that one group is a valid control for the other. Screening status was not described as randomly assigned, and the registry notes that the arms are not a like-for-like control comparison. Differences in perspectives between these categories, if reported elsewhere, would not by themselves show that screening status caused those perspectives.

The registry lists enrollment of 82 and describes 32 screened patients, 29 patients who had not completed screening, and a group of 20 health-system personnel. It does not explain in the record how enrollment relates to the numbers in the group descriptions, whether all enrolled participants completed interviews, or whether any interviews were excluded from analysis. These details matter for understanding how representative the analyzed material may be of those recruited.

The registry reports 0 analyses. It provides no inferential estimates, confidence intervals, p-values, or numerical theme results. Consequently, there is no basis in the registry record for assessing statistical precision, comparing group-level rates, or determining whether a quantitative difference is compatible with chance. The absence of a statistical analysis is not evidence that a particular view was common or uncommon; it means the corresponding estimate is unavailable in this record.

The study’s stated context includes challenges to providing preventive services during the COVID-19 pandemic and uncertainty about patient perceptions of disease risk and pandemic-related risk. These points explain the motivation for asking about barriers, beliefs, and information needs. They do not supply results. The record does not establish which barriers patients raised, what information they preferred, or whether any perspectives differed by screening status or stakeholder role.

Interpretation should therefore remain at the level of study purpose and recorded design. The registry identifies who was intended to be interviewed and what topics the interview guide addressed, but does not report the findings needed to answer the primary question. Any conclusion about the themes themselves, their frequency, or implications for screening uptake is not supported by the registry record.

9. Statistical Methods Explained

The record identifies semi-structured interviews as the study activities. In general, a semi-structured interview uses a planned set of topics while allowing follow-up questions and participants’ own explanations. This can be useful when a study seeks to understand perceptions, barriers, and information needs rather than estimate the effect of an assigned treatment. The registry describes an interview guide covering understanding, attitudes, beliefs, perceived risk, barriers to preventive and other healthcare, and information needed for decisions during the COVID-19 pandemic.

The primary outcome is expressed as a number of themes. In general, thematic analysis involves organizing interview material into meaningful patterns or topics. A reproducible theme count depends on operational details: what qualifies as a theme, whether a passage can contribute to more than one theme, how coding is conducted, and how disagreements are handled. Those details are not reported in the registry record. The record also does not state whether the analysis was inductive, based on a prespecified framework, or a combination of approaches. No particular coding method should therefore be assumed.

In quantitative studies, estimates are often accompanied by confidence intervals. In general, a confidence interval describes uncertainty around an estimate under the assumptions of the statistical method used; it does not guarantee that the estimate captures a population truth. The registry record provides no numerical theme estimate and no confidence interval. It is therefore not possible to assess precision in that way. Nor does the listed unit “Themes” establish that a theme count was treated as a conventional numeric outcome in a statistical model.

The record lists 0 analyses. No model, test, adjustment strategy, or group comparison is reported in the registry record. It does not state whether patient themes were compared between screened and not-screened participants, or whether stakeholder interviews were analyzed separately from patient interviews. A difference in the number of themes across groups, if calculated, would depend on how the interview material was collected and coded and on the number of interviews included. Such a result is not available in the registry record.

In general, the number and composition of participants influence what a qualitative interview study can capture. A larger set of interviews does not automatically make a theme more representative, because participants may differ in relevant experiences and the analysis depends on the content and depth of the interviews. The registry reports enrollment of 82 and describes patient and health-system groups, but does not report recruitment response, reasons for nonparticipation, or whether data collection continued until a stated saturation criterion was met. Saturation procedures are not reported in the registry record.

The record’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Those assumptions do not establish that the study was designed as a randomized comparison. The record itself states that this is not a randomized comparison and that allocation is not stated. No numerical effect or numerical planning result is available in the registry record, so the illustration cannot be interpreted as evidence of study power or as an explanation of the enrollment target. Planning illustrations are not observed power.

In general, statistical power is a design-stage probability concerning detection of a specified effect under stated assumptions. It is not a measure of whether a result is true, and it should not be inferred from the fact that a study was completed. The registry record does not report a study-specific power calculation or sample-size justification. The listed illustration should not be mistaken for the study’s own design rationale, particularly because the stated primary outcome is a theme count and no corresponding numerical result or effect estimate is reported.

The record lists a primary outcome timeframe of 6 months. The description specifies that patients were due for screening between April-July 2020, and that the not-screened group had not completed the relevant screening test from April 2020 to the interview date. The registry does not explain how the timeframe was operationalized for each participant or how interviews were scheduled relative to screening decisions. Details about the timing and duration of the interview process are not reported in the registry record.

In general, missing-data methods describe how incomplete observations are handled and what assumptions support an analysis. The registry does not report whether any interview data were incomplete, whether participants withdrew, or how missing material was handled. It also does not describe an analysis population beyond the stated participant groups. These omissions limit assessment of the path from recruitment to the analyzed material, but they do not imply that data were missing.

Finally, the record’s count of 0 analyses means no statistical analysis is listed there; it does not establish what analytic work, if any, may have been conducted outside the registry entry. The registry provides no reproducible analysis plan, coding protocol, or numerical output. General principles about qualitative coding and statistical uncertainty can clarify what information would be needed, but they cannot fill in the unreported methods or results.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 3 outcome measures, but only the primary outcome is described in the available record details. The other outcome measures and their definitions are not reported in the registry record. It also lists 0 analyses. No statistical analysis plan, prespecified hierarchy of outcomes, or approach to multiple testing is reported in the registry record.

In general, multiplicity arises when several outcomes, comparisons, or analytic choices are examined. If many statistical tests are performed, the chance of at least one apparently notable result can increase unless the analysis accounts for the testing strategy. That general concern cannot be evaluated because no tests or numerical analyses are reported. For the same reason, there is no basis for stating whether any multiplicity adjustment was or was not applied outside the registry record.

The registry identifies patient groups by screening status and a separate health-system stakeholder group. It does not state whether analyses were planned separately by group, whether themes were to be compared across groups, or whether any subgroup findings were prespecified. Those details are not reported in the registry record and should not be inferred from the existence of group descriptions.

The record does not report the number of people who were invited, declined, or did not complete an interview, and it does not say how incomplete interviews or missing responses were treated. It also does not define an analysis population beyond the described participant groups. These omissions prevent an assessment of possible selection or missing-data effects. They do not establish that missing data occurred.

11. Safety Results

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

ArmParticipants with serious adverse eventsParticipants at riskPercentage
Healthcare System Leadership, Providers, and Staff0200.0%
Not Screened Patients0290.0%
Screened Patients0320.0%

Deaths

ArmDeaths (participants affected of at risk)
Healthcare System Leadership, Providers, and Staff0 of 20
Not Screened Patients0 of 29
Screened Patients0 of 32

Other (non-serious) adverse events

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

ArmParticipants affected of at risk
Healthcare System Leadership, Providers, and Staff0 of 20
Not Screened Patients0 of 29
Screened Patients0 of 32
Do not overextend the safety comparison. Serious-adverse-event counts are safety observations, not efficacy outcomes, and should not be combined with the primary result into a single benefit-risk number.

The registry’s adverse-event listing records 0 serious adverse events and 0 other adverse events for each of the three groups: healthcare-system leadership, providers, and staff; not-screened patients; and screened patients. The listed numbers at risk are 20, 29, and 32, respectively. These figures are safety-record entries, not the primary outcome of the interview study.

The record describes semi-structured interviews rather than a clinical treatment assignment. The adverse-event figures therefore should not be read as a comparison of treatment safety or as evidence about the safety of cancer screening procedures. The group labels refer to interview participants, and the registry does not describe random allocation or a treatment-versus-control design.

In general, a recorded zero means that no events are listed in the relevant registry fields; it does not establish that an event was impossible or that every event would necessarily have been detected. The record does not describe event-collection procedures, definitions, or follow-up for adverse events. It also lists no serious adverse-event terms. These data can be reported as entered, but they do not support broader conclusions about clinical safety.

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

The record establishes that the study was designed to gather perspectives on screening and healthcare decisions during the COVID-19 pandemic through semi-structured interviews. It identifies the broad patient groups and stakeholder roles, describes the topics in the patient interview guide, and gives the primary outcome’s intended unit as a number of themes. It also records enrollment of 82 and a completed study status.

Those details do not reveal what participants said. The registry record does not report the number of themes, their names, how often they were identified, or whether they differed between screened and not-screened patients. It also does not report the results of the health-system interviews. Therefore, the record cannot establish which factors influenced decisions, what information participants wanted, or how stakeholders understood screening barriers during the pandemic.

The study does not provide a randomized comparison. Screening status was not assigned, allocation is not stated, and the registry warns that the groups are not a like-for-like control comparison. Even if the record included descriptive differences between groups, those differences would not alone demonstrate that screening status caused a difference in perceptions or decisions. The registry includes no numerical analyses that could quantify such differences.

In general, qualitative findings can help describe experiences and generate questions for later research or implementation work. Their interpretation depends on how participants were recruited, how interviews were conducted, and how accounts were analyzed. Those methods are not fully reported in the registry record. The intended subject matter is clear, but the findings and their evidential basis are not available for evaluation.

The record should not be read as evidence that a particular screening strategy increased uptake, improved decision quality, or changed healthcare use. It contains no reported intervention effect, comparator estimate, or outcome result supporting those claims. Its contribution in the registry is to document an interview study and its intended focus; the substantive conclusions remain not reported in the registry record.

13. Why This Trial Matters Statistically

This study matters statistically because it illustrates the difference between a clinical trial designed to estimate a treatment effect and an interview study designed to understand perspectives. The registry lists interview activities and a primary outcome defined as a number of themes. It does not report a randomized intervention comparison, and the record explicitly cautions that the groups are not a like-for-like control comparison. Applying the language of efficacy or control-group effects would therefore misrepresent the design.

The distinction also affects what can be learned from a sample-size illustration. The registry describes assumptions for a planning calculation based on an observed effect, but those assumptions do not establish the study’s design rationale or turn the interview groups into randomized arms. A planning calculation is not an observed result, and it is not observed power. The record does not report the study’s own sample-size justification or numerical power calculation.

For a theme-count outcome, transparent definitions and coding procedures are central to interpreting the measure. Without a reported theme definition, coding process, or numerical result, readers cannot assess how consistently the themes were identified or how the count relates to participant experiences. The missing result also means there is no estimate whose statistical precision can be evaluated.

The study’s focus is situated in a period when the brief summary describes challenges to preventive services and uncertainty about perceptions of disease and pandemic-related risk. The interview topics are therefore relevant to understanding how people and health systems approached screening decisions in that context. Statistical interpretation still depends on separating the motivation for the study from the findings actually reported. The registry records the former more fully than the latter.

14. Limitations

The main limitation for interpreting this registry entry is that it does not report the primary outcome result. The number and content of themes are not reported in the registry record, and there are no listed analyses. Readers therefore cannot evaluate whether the stated research question was answered or assess the strength and precision of any findings.

The registry gives limited detail about how interview data were collected and analyzed. It does not report recruitment procedures, participant response, interview completion, transcription, coding rules, coder training, disagreement resolution, or procedures for assessing whether analysis had captured the intended topics. These details are important to judging how the reported themes, if available, would have been produced. Their absence from the record does not establish that such procedures were not used.

The participant descriptions do not fully explain how enrollment of 82 relates to the listed groups of 32 screened patients, 29 not-screened patients, and 20 health-system personnel. The registry does not report whether these counts describe all enrolled participants, how many completed interviews, or how many contributed to the primary analysis. It also does not report whether the patient groups differed in relevant characteristics.

The record gives a broad interview timeframe and a 6 months outcome timeframe but does not describe how timing was defined for each participant. It does not report how incomplete interviews or missing information were handled. As a result, the completeness of the analyzed material cannot be assessed from the registry record.

Finally, the screened and not-screened patient categories are not randomized comparison groups. The record states that allocation is not stated and that the arms are not a like-for-like control comparison. The registry also does not provide results for the health-system interviews or descriptions of the other outcome measures. These limits constrain interpretation to the study’s documented purpose and design rather than substantive conclusions about barriers, facilitators, or screening effects.

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18. Record Summary

The registry record identifies NCT04683744 as a completed study titled “Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation,” sponsored by Indiana University. It lists enrollment of 82, a study start date of 2021-01-11, and a primary completion date of 2023-05-03. The condition is colorectal cancer screening.

The study activities are semi-structured interviews with patients and health-system personnel. The primary outcome concerns the number of themes identified in patient interviews about screening and other healthcare decisions, and information needs during the COVID-19 pandemic. The record describes 32 patients who completed screening in 2020 and 29 who had not completed the relevant screening test by interview, as well as 20 health-system leadership, providers, and staff.

The registry lists 3 outcome measures and 0 analyses. The numerical primary outcome, other outcome details, and statistical results are not reported in the registry record. The study is not described as a randomized comparison, and the registry cautions that the groups are not like-for-like controls.

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