Impact of Protect Your Colon™ on CRC Screening

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: Protect Your Colon™

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher V Almario, MD, MSHPM; Phone Number: 310.423.4462; Email: Christopher.Almario@csmc.edu
• Study Contact Backup: Name: Muskaan R Mehra, MS; Phone Number: 310.423.0715; Email: muskaan.mehra@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Antwon Chaplin, BA; Phone Number: 310.248.6790; Email: Antwon.Chaplin@cshs.org
      • Principal Investigator: Christopher V Almario, MD, MSHPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (Control); 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.
Experimental: Protect Your Colon™ (Intervention); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of completion of a CRC screening test	Uptake of CRC screening within 6 months of patients' initial visit	6 months post visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Christopher V Almario, MD, MSHPM, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Colonoscopy; CT scan; Decision aid; Stool test
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STUDY2402; K08CA245033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.
• IPD Sharing Time Frame: Data will become available after study completion and for up to 3 years after study completion.
• IPD Sharing Access Criteria: The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No