Impact of Protect Your Colon™ on CRC Screening
ConditionColorectal Cancer Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Does not speak English
Does not have internet access
Any records flagged "break the glass" or "research opt out."
Trial design
Design model
Parallel
Treatments tested in this trial
Protect Your Colon™
BehavioralProtect 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.
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: Protect Your Colon™ (Intervention)Experimental treatment 1 intervention
Group B: Usual Care (Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of completion of a CRC screening test
Uptake of CRC screening within 6 months of patients' initial visit
Time frame
6 months post visitSecondary outcomes
1
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™
Time frame
1 day post visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov