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Clinical Trials/NCT05929820
NCT05929820
Recruiting
Not Applicable

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

Cedars-Sinai Medical Center1 site in 1 country184 target enrollmentSeptember 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
Cedars-Sinai Medical Center
Enrollment
184
Locations
1
Primary Endpoint
Rate of completion of a CRC screening test
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2023
End Date
June 30, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Almario

Assistant Professor

Cedars-Sinai Medical Center

Eligibility Criteria

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."

Outcomes

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(1 day post visit)

Study Sites (1)

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