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Impact of Protect Your Colon™ on CRC Screening

Pilot Randomized Controlled Trial Assessing the Impact of Protect Your Colon™ on Colorectal Cancer Screening Behaviors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05929820
Enrollment
184
Registered
2023-07-03
Start date
2023-09-28
Completion date
2026-09-30
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Keywords

Decision aid, Stool test, Colonoscopy, CT scan

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.

Interventions

BEHAVIORALProtect Your Colon™

Protect 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.

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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."

Design outcomes

Primary

MeasureTime frameDescription
Rate of completion of a CRC screening test6 months post visitUptake of CRC screening within 6 months of patients' initial visit

Secondary

MeasureTime frameDescription
Qualitative feedback on details of CRC screening test1 day post visitCompletion 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™

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChristopher V Almario, MD, MSHPM

Cedars-Sinai Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026