Impact of Protect Your Colon™ on CRC Screening

NCT05929820 | Recruiting

• 1 other identifier: STUDY2402
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Screening

Keywords

Decision aid; Stool test; Colonoscopy; CT scan

Outcome Measures

Primary Outcomes (1)

• Rate of completion of a CRC screening test

  Uptake of CRC screening within 6 months of patients' initial visit

  6 months post visit

Secondary Outcomes (1)

• Qualitative feedback on details of CRC screening test

  1 day post visit

Study Arms (2)

Protect Your Colon™ (Intervention)

EXPERIMENTAL

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™

Usual Care (Control)

NO INTERVENTION

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.

Interventions

Protect Your Colon™ BEHAVIORAL

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.

Protect Your Colon™ (Intervention)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Does not speak English
• Does not have internet access
• Any records flagged "break the glass" or "research opt out."

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Study Officials

• Christopher V Almario, MD, MSHPM

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher V Almario, MD, MSHPM

CONTACT

310.423.4462; Christopher.Almario@csmc.edu

Muskaan R Mehra, MS

CONTACT

310.423.0715; muskaan.mehra@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: July 3, 2023
• Study Start: September 28, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after study completion and for up to 3 years after study completion.
• Access Criteria: The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.

Locations

US (1)