Cancer Screening TestsNCT04683731
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
A study testing Decision aid without personalized message, Decision aid with personalized message and Provider notification without personalized message in people with Cancer Screening Tests, run by Indiana University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cancer Screening Tests
- What is being tested?
- Decision aid without personalized message, Decision aid with personalized message and Provider notification without personalized message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,111 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jan 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PATIENTS will be eligible if they are:
- age 50 - 75 years
- have not had a colonoscopy performed in the last 10 years, sigmoidoscopy in the last 5 years, fecal occult blood testing (FOBT or FIT) in the last year, or Cologuard in the last 3 years
- have not had a colonoscopy since turning 50 years old
- have a scheduled appointment with a provider who agreed to participate in the study
- PROVIDERS will be eligible if they are:
- a physician (MD or DO), nurse practitioner (NP), or physicians assistant (PA) practicing at a partner research site
Who cannot join
- PATIENTS will be excluded if they are:
- undergoing workup for symptoms consistent with CRC, such as unexplained weight loss, change in bowel habit, or rectal bleeding
- have a diagnosis or medical history conferring elevated risk for CRC including a previous adenomatous polyp or CRC, inflammatory bowel disease, high-risk syndromes, or a significant family history of CRC (two or more first degree relatives (FDR) with CRC or one FDR with a CRC diagnosis prior to age 60)
- are unable to speak and read English
- previously participated in any research projects regarding colorectal cancer screening or colonoscopy including, but not limited to the investigators' previous studies
- members of the study team will not be participating in the study; therefore, patients who have a scheduled appointment with any member of the study team will not be eligible.
- PROVIDERS will be excluded if they:
- do not have patients between 50 - 75 years old.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Indianapolis, Indiana, 462020
Indiana University
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
The research team has developed and pilot tested a decision aid and provider message that discloses the patient's current risk of ACN, based on a prediction rule developed and validated by Dr. Thomas Imperiale, a member of the study team. The Imperiale Prediction Rule uses five variables (gender, age, CRC family history, waist circumference, and smoking history) and identifies a wide range of risk for current ACN among average risk patients. For patients with "high-average" risk (22%), personalized messages in the decision aid and provider notification highlight the advantage of colonoscopy because of the likelihood of finding and removing an ACN. For patients at low risk for ACN (2% or 4%), personalized messages highlight the advantage of stool testing, due to the relatively low chance of failing to detect ACN.
The investigators' long-term goal is to increase uptake of CRC screening by informing and improving patient and provider discussion and decisions. The main objective of this project is to test whether providing patients and their providers with personalized messages about ACN risk results in higher screening uptake and higher decision quality, compared to an approach that does not utilize ACN risk.
- Conditions
- Cancer Screening Tests
- Being tested
- Decision aid without personalized message, Decision aid with personalized message, Provider notification without personalized message, Provider notification with personalized message
- Keywords
- decision aid, cancer screening, risk assessment, risk communication, colorectal neoplasm, decision making
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aid without personalized messageBehavioural
The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
Decision aid with personalized messageBehavioural
The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
Provider notification without personalized messageBehavioural
Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the electronic health record (EHR) within 24 hours of their visit with the enrolled patient.
Provider notification with personalized messageBehavioural
Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the electronic health record (EHR) within 24 hours of their visit with the enrolled patient.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients view decision aid without personalized message and whose providers do not receive the personalized message. Receives: Behavioral: Decision aid without personalized message; Behavioral: Provider notification without personalized message |
| Group 2 | Experimental | Patients view decision aid with personalized message and whose providers do not receive the personalized message. Receives: Behavioral: Decision aid with personalized message; Behavioral: Provider notification without personalized message |
| Group 3 | Experimental | Patient view decision aid without the personalized message and whose providers receive the personalized message. Receives: Behavioral: Decision aid without personalized message; Behavioral: Provider notification with personalized message |
| Group 4 | Experimental | Patients view decision aid with the personalized message and whose providers receive the personalized message. Receives: Behavioral: Decision aid with personalized message; Behavioral: Provider notification with personalized message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed Colorectal Cancer Screening
Patients' completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening within 6 months, based on documentation in the participants' electronic health record.
Measured: 6 months after patient enrollment
Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.
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 survey and the screening test underwent, if any, within 6 months after patient enrollment.
Measured: 6 months after participant enrollment
Secondary outcomes (11)
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed
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).
Measured: 6 months after participant enrollment
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
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.
Measured: 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)
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
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.
Measured: 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)
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.
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 for change could be -12 to 12 with higher values meaning an increase in knowledge which is a better outcome.
Measured: 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)
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
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 point minus the mean of the former time point.
The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk.
Measured: 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)
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
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.
Measured: 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)
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
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.
Measured: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument
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.
Measured: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE
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.
Measured: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test
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).
Measured: 6 months after patient enrollment
Number of Providers Who Open Their Provider Notification
Opening the provider notification sent for each patient was assessed by reviewing the electronic health record (EHR).
Measured: 6 months after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start19 Jan 2021
- Primary completion17 May 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer Screening TestsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2x2, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Peter Schwartz, Indiana University
- Investigators
- Peter H. Schwartz, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683731
- Sponsor's protocol ID
- 2004109966
- Other IDs
- CDR-2018C3-14715
- Status last verified
- Nov 2024
- First submitted
- 20 Dec 2020
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, researchers who contact the PI with an IRB-approved protocol may be provided de-identified IPD following our institution's data sharing policies.
Publications
Schwartz PH, Imperiale TF, Perkins SM, Schmidt KK, Althouse S, Rawl SM. Effect of Personalized Risk Messages on Patient Intent and Decision Making in Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2026 Jul 28:272989X261455045. doi: 10.1177/0272989X261455045. Online ahead of print.
PubMed 42517432Schwartz PH, Perkins SM, Rawl SM, Schmidt KK, Althouse S, Imperiale TF. Effect of Personalized Risk Messages on Uptake of Colorectal Cancer Screening : A Randomized Controlled Trial. Ann Intern Med. 2025 Oct;178(10):1390-1399. doi: 10.7326/ANNALS-24-03144. Epub 2025 Sep 2.
PubMed 40889370
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT04683731
- Acronym / sponsor ID
- 2004109966
- Conditions
- Cancer Screening Tests
- Keywords
- decision aid, cancer screening, risk assessment, risk communication, colorectal neoplasm, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research team has developed and pilot tested a decision aid and provider message that discloses the patient's current risk of ACN, based on a prediction rule developed and validated by Dr. Thomas Imperiale, a member of the study team. The Imperiale Prediction Rule uses five variables (gender, age, CRC family history, waist circumference, and smoking history) and identifies a wide range of risk for current ACN among average risk patients. For patients with "high-average" risk (22%), personalized messages in the decision aid and provider notification highlight the advantage of colonoscopy because of the likelihood of finding and removing an ACN. For patients at low risk for ACN (2% or 4%), personalized messages highlight the advantage of stool testing, due to the relatively low chance of failing to detect ACN.
The investigators' long-term goal is to increase uptake of CRC screening by informing and improving patient and provider discussion and decisions. The main objective of this project is to test whether providing patients and their providers with personalized messages about ACN risk results in higher screening uptake and higher decision quality, compared to an approach that does not utilize ACN risk.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2x2, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: Decision aid without personalized message, Behavioral: Provider notification without personalized messagePatients view decision aid without personalized message and whose providers do not receive the personalized message. |
| Group 2 | Experimental | Behavioral: Decision aid with personalized message, Behavioral: Provider notification without personalized messagePatients view decision aid with personalized message and whose providers do not receive the personalized message. |
| Group 3 | Experimental | Behavioral: Decision aid without personalized message, Behavioral: Provider notification with personalized messagePatient view decision aid without the personalized message and whose providers receive the personalized message. |
| Group 4 | Experimental | Behavioral: Decision aid with personalized message, Behavioral: Provider notification with personalized messagePatients view decision aid with the personalized message and whose providers receive the personalized message. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 50 - 75 years
- have not had a colonoscopy performed in the last 10 years, sigmoidoscopy in the last 5 years, fecal occult blood testing (FOBT or FIT) in the last year, or Cologuard in the last 3 years
- have not had a colonoscopy since turning 50 years old
- have a scheduled appointment with a provider who agreed to participate in the study
- a physician (MD or DO), nurse practitioner (NP), or physicians assistant (PA) practicing at a partner research site
Key exclusion criteria (8 listed)
- undergoing workup for symptoms consistent with CRC, such as unexplained weight loss, change in bowel habit, or rectal bleeding
- have a diagnosis or medical history conferring elevated risk for CRC including a previous adenomatous polyp or CRC, inflammatory bowel disease, high-risk syndromes, or a significant family history of CRC (two or more first degree relatives (FDR) with CRC or one FDR with a CRC diagnosis prior to age 60)
- are unable to speak and read English
- previously participated in any research projects regarding colorectal cancer screening or colonoscopy including, but not limited to the investigators' previous studies
- members of the study team will not be participating in the study; therefore, patients who have a scheduled appointment with any member of the study team will not be eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aid without personalized messageThe decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long. | Behavioural | Group 1, Group 3 |
| Decision aid with personalized messageThe decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long. | Behavioural | Group 2, Group 4 |
| Provider notification without personalized messageProviders will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the electronic health record (EHR) within 24 hours of their visit with the enrolled patient. | Behavioural | Group 1, Group 2 |
| Provider notification with personalized messageProviders will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the electronic health record (EHR) within 24 hours of their visit with the enrolled patient. | Behavioural | Group 3, Group 4 |
Primary outcome
Number of Participants Who Completed Colorectal Cancer Screening
Time frame: 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.
Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.
Time frame: 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 survey and the screening test underwent, if any, within 6 months after patient enrollment.
11 secondary outcomes
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed
Time frame: 6 months after participant enrollment
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Time frame: 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)
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior
Time frame: 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)
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.
Time frame: 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)
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Time frame: 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)
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit
Time frame: 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)
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4
Time frame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument
Time frame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE
Time frame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]
Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test
Time frame: 6 months after patient enrollment
Number of Providers Who Open Their Provider Notification
Time frame: 6 months after patient enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42517432Schwartz PH, Imperiale TF, Perkins SM, Schmidt KK, Althouse S, Rawl SM. Effect of Personalized Risk Messages on Patient Intent and Decision Making in Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2026 Jul 28:272989X261455045. doi: 10.1177/0272989X261455045. Online ahead of print.
- Derived from this study: PubMed 40889370Schwartz PH, Perkins SM, Rawl SM, Schmidt KK, Althouse S, Imperiale TF. Effect of Personalized Risk Messages on Uptake of Colorectal Cancer Screening : A Randomized Controlled Trial. Ann Intern Med. 2025 Oct;178(10):1390-1399. doi: 10.7326/ANNALS-24-03144. Epub 2025 Sep 2.
- Individual participant dataSharing planned: Yes. Yes, researchers who contact the PI with an IRB-approved protocol may be provided de-identified IPD following our institution's data sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter H. Schwartz, MD, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid without personalized message, Decision aid with personalized message and Provider notification without personalized message in people with Cancer Screening Tests, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed Colorectal Cancer Screening (time frame: 6 months after patient enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683731, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.