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Trial Title:
Impact of Protect Your Colon™ on CRC Screening
NCT ID:
NCT05929820
Condition:
Colorectal Cancer Screening
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Decision aid
Stool test
Colonoscopy
CT scan
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Protect Your Colon™
Description:
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.
Arm group label:
Protect Your Colon™ (Intervention)
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.
Criteria for 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)
Exclusion Criteria:
- Does not speak English
- Does not have internet access
- Any records flagged "break the glass" or "research opt out."
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Antwon Chaplin, BA
Phone:
310-248-6790
Email:
Antwon.Chaplin@cshs.org
Investigator:
Last name:
Christopher V Almario, MD, MSHPM
Email:
Principal Investigator
Start date:
September 28, 2023
Completion date:
October 1, 2025
Lead sponsor:
Agency:
Cedars-Sinai Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05929820
