Understanding Patient Preference on Colorectal Cancer Screening Options

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Early detection by screening significantly reduces mortality from colorectal cancer (CRC). However, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. Not being up to date with screening was associated with an approximate 3-fold risk for CRC-related mortality. There are different well-established CRC screening modalities, including invasive and non-invasive, which detect both polyps and cancer or cancer alone. Colonoscopy remains the dominant screening modality in the U.S.; however, colonoscopy uptake is low due to the invasiveness, perception of discomfort and embarrassment, logistical challenges, cost, and potential risks. Increasing patient compliance and adherence to screening is critical to improving CRC outcomes. A key to enhancing screening participation is patient acceptance of the testing method. A blood-based screening test presents an opportunity to overcome some challenging barriers. Blood-based tests are non-invasive compared to colonoscopy and can easily be part of a standard medical office appointment for a wellness check or scheduled visits to manage chronic illnesses and be completed at the point of care. This study will examine patient preference to use a blood-based screening test and compliance with CRC screening recommendations after failing to complete the FIT (Fecal Immunochemical Test)/FOBT (Fecal Occult Blood Test) or colonoscopy order in six months. Compliance with CRC screening is particularly poor among medically underserved populations, and most of these vulnerable individuals use federally qualified health centers (FQHCs) to obtain care. Implementing a blood-based screening test at FQHCs has the potential to improve CRC screening uptake and adherence and improve health disparities in medically underserved populations. This study seeks to answer the following four questions: 1) What is the acceptability of a blood-based screening as an alternative for patients who failed to complete a prior order using traditional screening methods? 2) Are patients who failed to comply with traditional screening methods more likely to comply with a blood-based screening test? 3) What is the effect of offering a blood-based screening test for patients who are non-compliance with traditional screening methods on overall CRC screening rates? 4) What are the facilitators and barriers to implementing the blood-based screening test in clinical settings?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: t
View:

• Between 45-75 years of age

• Have an average risk for colorectal cancer

• A patient at one of our partner FQHCs

• Received a screening order (either using a stool-based test or colonoscopy) six months ago and failed or refused to complete the screening test

• Able to comprehend and willing to give informed consent

• Able and willing to provide a blood sample per protocol

Locations
United States
Illinois
PCC Community Wellness Center
RECRUITING
Chicago
Contact Information
Primary
Helen Y Lam, Ph.D.
hvallina@medicine.bsd.uchicago.edu
773-702-2613
Backup
Karen Kim, MD
kekim@medicine.bsd.uchicago.edu
773-834-9475
Time Frame
Start Date: 2023-02-09
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 500
Treatments
Federally Qualified Health Center 1
Patients who received an order for colorectal cancer screening, either using a stool-based test or colonoscopy, but failed to complete the screening after six months will be recruited to participate in the study.
Federally Qualified Health Center 2
Patients who received an order for colorectal cancer screening, either using a stool-based test or colonoscopy, but failed to complete the screening after six months will be recruited to participate in the study.
Federally Qualified Health Center 3
Patients who received an order for colorectal cancer screening, either using a stool-based test or colonoscopy, but failed to complete the screening after six months will be recruited to participate in the study.
Related Therapeutic Areas
Sponsors
Leads: Milton S. Hershey Medical Center

This content was sourced from clinicaltrials.gov