Impact of Protect Your Colon™ on CRC Screening

Not Applicable

Recruiting

• Conditions: Colorectal Cancer Screening
• Interventions: Behavioral: Protect Your Colon™

• 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: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• 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

Arm && Interventions

Group	Intervention	Description
Protect Your Colon™ (Intervention)	Protect Your Colon™	Patients randomized to Protect Your Colon™ will be directed to go through the website at least 2 days before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit.

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