Assessing a decision aid for colorectal cancer screening
Pilot Randomized Controlled Trial Assessing the Impact of Protect Your Colon™ on Colorectal Cancer Screening Behaviors
This study is testing a new tool called Protect Your Colon™ to see if it helps people make better decisions about colorectal cancer screening and actually get screened more often.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05929820 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of Protect Your Colon™, a decision aid designed to enhance colorectal cancer (CRC) screening behaviors among patients. The study hypothesizes that by improving shared decision-making, the aid will help patients choose screening tests that align with their values and ultimately increase screening rates. A pilot randomized controlled trial will compare the outcomes of patients using Protect Your Colon™ against those receiving usual care, focusing on communication, intent to screen, and actual screening uptake.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 75 who are either not up-to-date with CRC screening or have never been screened.
Not a fit: Patients with a high risk for colorectal cancer or those who do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to increased colorectal cancer screening rates, improving early detection and outcomes for patients.
How similar studies have performed: Other studies have shown promising results with decision aids in improving screening rates, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
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."
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Christopher V Almario, MD, MSHPM — Cedars-Sinai Medical Center
- Study coordinator: Christopher V Almario, MD, MSHPM
- Email: Christopher.Almario@csmc.edu
- Phone: 310.423.4462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.