Impact of Protect Your Colon™ on CRC Screening

Not Applicable

Recruiting

• Conditions: Colorectal Cancer Screening

• Registration Number: NCT05929820
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-03
• Study Start: 2023-09-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Individuals 45 to 75 years old
• No prior CRC screening or not up-to-date with CRC screening
• Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC)

Exclusion Criteria

• Does not speak English
• Does not have internet access
• Any records flagged "break the glass" or "research opt out."

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of completion of a CRC screening test	6 months post visit	Uptake of CRC screening within 6 months of patients' initial visit

Secondary Outcome Measures

Name	Time	Method
Qualitative feedback on details of CRC screening test	1 day post visit	Completion of questionnaire that looks at: * Whether CRC screening discussions took place during the visit; * What specific CRC screening tests were discussed during the visit; * Patient's intent to complete CRC screening; * Patient's perceptions on feeling informed about the alternatives, benefits, and risks of the different screening options as well as their clarity on their personal values; * Patient's assessment of shared decision making on CRC screening; * Intervention patients' assessment of the usefulness of Protect Your Colon™

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States