Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Location status: Recruiting
Location contact
Antwon Chaplin, BA
CONTACT
Christopher V Almario, MD, MSHPM
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT05929820
Impact of Protect Your Colon™ on CRC Screening
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
45 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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."
Treatment and study plan
Protect Your Colon™
BehavioralProtect Your Colon™ is an online decision aid focused on CRC screening. The site will first educate patients on the importance of CRC screening and offer information on the advantages and disadvantages of the available test options. Protect Your Colon™ will then present an interactive conjoint analysis-a quantitative survey technique that elucidates how individuals make complex decisions-to precisely determine individuals' latent preferences regarding CRC screening options. Afterwards, the app will generate a personalized report that rank orders the importance of each test attribute (e.g., accuracy, invasiveness, test frequency) in patients' decision making and identifies the screening modality that best matches their preferences. The report will also be shareable with physicians, enabling patients and providers to engage in shared decision making surrounding CRC screening in the clinic.
Primary outcomes
-
Rate of completion of a CRC screening test
Time frame: 6 months post visit
Uptake of CRC screening within 6 months of patients' initial visit
Secondary outcomes
-
Qualitative feedback on details of CRC screening test
Time frame: 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™
Study contacts
Contact information is provided by the study sponsor or research team.
Christopher V Almario, MD, MSHPM
CONTACT
Muskaan R Mehra, MS
CONTACT
Sponsors and collaborators
Lead sponsor
Cedars-Sinai Medical Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Pilot Randomized Controlled Trial Assessing the Impact of Protect Your Colon™ on Colorectal Cancer Screening Behaviors
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 3, 2023
- Registry last updated
- Jun 25, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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