Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

NCT04683731 | Completed Results

• 2 other identifiers: 2004109966CDR-2018C3-14715
• Study Type: interventional
• Target: 1,111
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cancer Screening Tests

Keywords

decision aid; cancer screening; risk assessment; risk communication; colorectal neoplasm; decision making

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months after participant enrollment

Secondary Outcomes (11)

• Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed

  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

  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

  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.

  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

  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)

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Patients view decision aid without personalized message and whose providers do not receive the personalized message.

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.

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.

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.

Behavioral: Decision aid with personalized message; Behavioral: Provider notification with personalized message

Interventions

Decision aid without personalized message BEHAVIORAL

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.

Group 1; Group 3

Decision aid with personalized message BEHAVIORAL

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.

Group 2; Group 4

Provider notification without personalized message BEHAVIORAL

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.

Group 1; Group 2

Provider notification with personalized message BEHAVIORAL

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.

Group 3; Group 4

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 462020, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Schwartz 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.

  PMID: 40889370 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Peter H. Schwartz, MD, PhD
• Organization: Trustees of Indiana University

phschwar@iu.edu

317-278-4037

Study Officials

• Peter H. Schwartz, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Provider-participants will know that their enrolled patient-participant is participating in the study but will not know what arm they were assigned.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2x2, randomized, controlled trial

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 24, 2020
• Study Start: January 19, 2021
• Primary Completion: May 17, 2023
• Study Completion: July 31, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting in Jan. 2025, indefinitely.
• Access Criteria: Contact PI Peter Schwartz (phschwar@iu.edu) and provide IRB-approved protocol for review. Decisions will be made that follow our institution's data sharing policies.

Locations

US (2)