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NCT05929820 Clinical Trial

Impact of Protect Your Colon™ on CRC Screening

Colorectal Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05929820
Other study ID # STUDY2402
Secondary ID K08CA245033
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2023
Est. completion date October 1, 2025

Study information
Verified date May 2024
Source Cedars-Sinai Medical Center
Contact Christopher V Almario, MD, MSHPM
Phone 310.423.4462
Email Christopher.Almario@csmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 184
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Protect 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.

Locations
Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Cedars-Sinai Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of completion of a CRC screening test Uptake of CRC screening within 6 months of patients' initial visit 6 months post visit
Secondary Qualitative feedback on details of CRC screening test 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™		 1 day post visit
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