Impact of Protect Your Colon™ on CRC Screening

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Colorectal Cancer Screening

Treatments: Behavioral: Protect Your Colon™

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05929820

STUDY2402

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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)
• No prior colon polyps
• Additional inclusion criteria for participants recruited through Cint online survey panels: (i) appointment with a primary care provider up to 6 weeks from time of screening, and (ii) have Preferred Provider Organization (PPO) insurance.

Exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups

Protect Your Colon™ (Intervention)

Experimental group

Description:

Patients randomized to Protect Your Colon™ will be directed to go through the website 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.

Treatment:

Behavioral: Protect Your Colon™

Usual Care (Control)

No Intervention group

Description:

The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment.