Adults 50 to 75, any sex, with Cancer Screening Tests. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Completed Colorectal Cancer ScreeningPrimary· 6 months after patient enrollment
Patients' completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening within 6 months, based on documentation in the participants' electronic health record.
Group
Value
95% CI
Group 1
110
Group 2
95
Group 3
113
Group 4
113
Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.Primary· 6 months after participant enrollment
Decision quality will be assessed using the multi-dimensional measure of informed consent (MMIC), where a high-quality decision is one where the individual has adequate knowledge regarding the available options and undergoes the screening test that he or she has chosen or that fits his or her values ("values concordance"). Patient knowledge of colorectal cancer and screening will be assessed by a 12-item test made up of 6 multiple choice questions and 6 true-false questions. Adequate knowledge = 9 correct. Concordance will be measured between the patient's test choice at the post-provider surv
Group
Value
95% CI
Group 1
90
Group 2
92
Group 3
91
Group 4
103
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedSecondary· 6 months after participant enrollment
Colorectal cancer (CRC) screening uptake and type of screening test completed within 6 months of enrolled was assessed, as documented in the electronic health record (EHR).
Group
Value
95% CI
Group 1
59
Group 2
39
Group 3
52
Group 4
51
Group 1
51
Group 2
56
Group 3
61
Group 4
62
Group 1
180
Group 2
167
Group 3
134
Group 4
172
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitSecondary· 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Patients' intention to be screened for CRC with any CRC screening test will be measured with 1 item: "Do you plan to get any type of colon cancer screening test within the next 6 months?". The response options were: 5=Definitely; 4=Probably; 3=May or may not; 2=Probably not; and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome.
Change from baseline (T0) to post-intervention (T1)
Group
Value
95% CI
Group 1
0.59
± 0.79
Group 2
0.68
± 0.86
Group 3
0.55
± 0.84
Group 4
0.63
± 0.83
Change from post-intervention (T1) to post-provider visit (T2)
Group
Value
95% CI
Group 1
0.23
± 0.93
Group 2
0.24
± 0.74
Group 3
0.24
± 0.82
Group 4
0.20
± 0.79
Change from baseline (T0) to post-provider visit (T2)
Group
Value
95% CI
Group 1
0.85
± 1.18
Group 2
0.94
± 1.01
Group 3
0.80
± 1.15
Group 4
0.82
± 1.05
Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorSecondary· 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
For those patients who answer the screening intent item with "definitely not," "probably not," or "may or may not", test choice will be categorized as "no screening". Those who answer Screening Intent with "Probably" or "Definitely" have Test Choice categorized based on their answer to a single item: "If you have a colon test, which one would you choose?" Response options are: Stool test (FIT or Cologuard), Colonoscopy, Another test, or Don't know.
Intended screening behavior at baseline (T0)
Group
Value
95% CI
Group 1
70
Group 2
58
Group 3
56
Group 4
79
Group 1
62
Group 2
53
Group 3
55
Group 4
70
Group 1
2
Group 2
3
Group 3
2
Group 4
2
Group 1
37
Group 2
37
Group 3
35
Group 4
32
Intended screening behavior at post-intervention (T1)
Group
Value
95% CI
Group 1
106
Group 2
82
Group 3
93
Group 4
86
Group 1
85
Group 2
106
Group 3
74
Group 4
133
Group 1
0
Group 2
0
Group 3
1
Group 4
0
Group 1
25
Group 2
18
Group 3
19
Group 4
19
Intended screening behavior at post-provider (T2)
Group
Value
95% CI
Group 1
104
Group 2
90
Group 3
83
Group 4
89
Group 1
92
Group 2
84
Group 3
89
Group 4
117
Group 1
1
Group 2
1
Group 3
0
Group 4
1
Group 1
6
Group 2
5
Group 3
2
Group 4
3
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Secondary· 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Knowledge was assessed with six multiple choice and six true/false questions regarding general information (including risk factors, screening test options, and test frequency) of CRC and CRC screening. Knowledge scores were derived by summing correct responses to the 12 individual knowledge questions (range, 0-12), and change was calculated from baseline (T0) to post-intervention (T1), post-intervention (T1) to post-provider visit (T2), and from baseline (T0) to post-provider (T2) by using the knowledge score at the later time point minus the knowledge score of the former time point. The range
Change in correct responses from baseline (T0) to post-intervention (T1)
Group
Value
95% CI
Group 1
3.65
± 2.68
Group 2
3.70
± 2.74
Group 3
3.75
± 2.82
Group 4
3.76
± 2.90
Change in correct responses from post-intervention (T1) to post-provider visit (T2)
Group
Value
95% CI
Group 1
-0.60
± 1.40
Group 2
-0.58
± 1.31
Group 3
-0.60
± 1.60
Group 4
-0.43
± 1.45
Change in correct responses from baseline (T0) to post-provider visit (T2)
Group
Value
95% CI
Group 1
3.03
± 2.71
Group 2
3.10
± 2.79
Group 3
3.02
± 3.02
Group 4
3.31
± 2.83
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitSecondary· 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Multiple choice questions assessing the patients' perception of how likely they are to get colon cancer in the next 5 years, in the next 10 years, and sometime during their lifetime. Each has response options: 4=very likely, 3=somewhat likely, 2=somewhat unlikely, and 1=very unlikely. The mean of the 3 questions was calculated (each combined score has a range of 1 to 4) at each time point. We calculated the change from baseline (T0) to post-intervention (T1), post-intervention (T1) to post-provider visit (T2), and from baseline (T0) to post-provider (T2) by using the mean of the later time poi
Change from baseline (T0) to post-intervention (T1)
Group
Value
95% CI
Group 1
0.21
± 0.74
Group 2
0.15
± 0.78
Group 3
0.14
± 0.81
Group 4
0.08
± 0.77
Change from post-intervention (T1) to post-provider visit (T2)
Group
Value
95% CI
Group 1
-0.10
± 0.86
Group 2
0.12
± 0.82
Group 3
0.10
± 0.87
Group 4
0.05
± 0.83
Change from baseline (T0) to post-provider visit (T2)
Group
Value
95% CI
Group 1
0.14
± 0.79
Group 2
0.28
± 0.87
Group 3
0.21
± 0.98
Group 4
0.14
± 0.84
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitSecondary· 1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)
Patients' decision conflict is assessed using the low literacy version of the Decision Conflict Scale, a ten-item instrument that assesses patients' subjective feeling regarding the decision process over five areas. Each item has three response categories (yes, no, unsure). Scores are summed; divided by 10; and multiplied by 25. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]. Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome.
Change from baseline (T0) to post-intervention (T1)
Group
Value
95% CI
Group 1
-36.6
± 28.9
Group 2
-42.4
± 27.6
Group 3
-37.1
± 27.7
Group 4
-40.3
± 28.4
Change from post-intervention (T1) to post-provider visit (T2)
Group
Value
95% CI
Group 1
-1.60
± 12.1
Group 2
-0.76
± 9.53
Group 3
-2.32
± 11.6
Group 4
-0.27
± 11.6
Change from baseline (T0) to post-provider visit (T2)
Group
Value
95% CI
Group 1
-39.0
± 29.2
Group 2
-41.6
± 28.8
Group 3
-37.9
± 29.2
Group 4
-39.3
± 29.2
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4Secondary· approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
Patients answered four items assessing the extent to which they were involved in the decision-making process. Each item had response options: 1= A lot; 2=Some; 3=A little; 4=Not at all. Each item was analyzed separately and responses "A lot", "Some" and "A little" were considered "enough" and received 1 point. The response "Not at all" was considered "not enough" and received 0 points.
How much did you and your provider talk about the reasons you might want to have a colonoscopy?
Group
Value
95% CI
Group 1
203
Group 2
178
Group 3
164
Group 4
201
Group 1
26
Group 2
28
Group 3
35
Group 4
35
Group 1
61
Group 2
56
Group 3
48
Group 4
49
How much did you and your provider talk about the reasons you might not want to have a colonoscopy?
Group
Value
95% CI
Group 1
106
Group 2
89
Group 3
91
Group 4
119
Group 1
123
Group 2
117
Group 3
108
Group 4
117
Group 1
61
Group 2
56
Group 3
48
Group 4
49
How much did you and your provider talk about the reasons you might want to do a stool test?
Group
Value
95% CI
Group 1
160
Group 2
146
Group 3
146
Group 4
173
Group 1
69
Group 2
60
Group 3
52
Group 4
63
Group 1
61
Group 2
56
Group 3
49
Group 4
49
How much did you and your provider talk about the reasons you might not want to do a stool test?
Group
Value
95% CI
Group 1
108
Group 2
92
Group 3
93
Group 4
111
Group 1
121
Group 2
114
Group 3
106
Group 4
124
Group 1
61
Group 2
56
Group 3
48
Group 4
50
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentSecondary· approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
A single-item measure taken from the Colon Cancer Testing Decision Quality Worksheet v.2.0 assessing if the patients' primary care provider asked them which type of colon cancer screening test they wanted.
Group
Value
95% CI
Group 1
152
Group 2
134
Group 3
130
Group 4
159
Group 1
76
Group 2
72
Group 3
69
Group 4
77
Group 1
62
Group 2
56
Group 3
48
Group 4
49
Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATESecondary· approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
A 3-item measure assessing how much effort was made by their provider to: explain colon cancer screening, ask for screening preferences, and incorporate those preferences into the decision. Response options ranged from 0="No effort was made" to 9="Every effort was made". The three items were summed and a mean was calculated. Scores can range from 0-9. A higher score indicates more perceived shared decision making. Higher perceived shared decision making is a better outcome.
Group
Value
95% CI
Group 1
6.4
± 3.1
Group 2
6.3
± 3.2
Group 3
6.3
± 3.2
Group 4
6.5
± 3.0
Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestSecondary· 6 months after patient enrollment
A FIT, colonoscopy, or other CRC screening test ordered within 6 months of each participants' enrollment based on documentation in the electronic health record (EHR).
Group
Value
95% CI
Group 1
89
Group 2
84
Group 3
79
Group 4
84
Group 1
201
Group 2
178
Group 3
168
Group 4
201
Sponsor's own description
Precision prevention holds great promise for colorectal cancer (CRC) screening but has not been adequately explored. A patient's chance of having an advanced colorectal neoplasm (ACN), i.e. a cancer or precancerous polyp in the colon, significantly affects the comparative effectiveness of approved tests. Giving patients a decision aid with information about their risk for ACN, and giving their providers similar information, could help patients and providers decide if colonoscopy or a non-invasive test (such as the fecal immunochemical test) is more appropriate. This could improve decision making and increase uptake of CRC screening, which are the investigative team's long-term goals.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 13 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04683731.