RECRUITING

Understanding Patient Preference on Colorectal Cancer Screening Options

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Understanding Patient Preference on Colorectal Cancer Screening Options

Quick Facts

Study Start:2023-02-09
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05536713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 45-75 years of age
  2. * Have an average risk for colorectal cancer
  3. * A patient at one of our partner FQHCs
  4. * Received a screening order (either using a stool-based test or colonoscopy) six months ago and failed or refused to complete the screening test
  5. * Able to comprehend and willing to give informed consent
  6. * Able and willing to provide a blood sample per protocol
  1. 1. Family history
  2. * One first-degree relative diagnosed with CRC or advanced adenoma at age \< 60 years
  3. * Two first-degree relatives diagnosed with CRC or advanced adenoma at any age
  4. * Known hereditary gastrointestinal cancer syndromes, such as Lynch Syndrome or Familial Adenomatous and Polyposis (FAP)
  5. 2. Personal History
  6. * History of CRC or adenoma
  7. * History of cancers
  8. * History of inflammatory bowel disease, including chronic ulcerative colitis and Crohn's disease
  9. * Have a recorded up-to-date CRC screening
  10. * Blood product transfusion in the past 120 days
  11. * A medical condition that, in the opinion of the patient's health provider, should preclude enrollment in the study

Contacts and Locations

Study Contact

Helen Y Lam, Ph.D.
CONTACT
773-702-2613
hvallina@medicine.bsd.uchicago.edu
Karen Kim, MD
CONTACT
773-834-9475
kekim@medicine.bsd.uchicago.edu

Principal Investigator

Karen Kim, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

PCC Community Wellness Center
Chicago, Illinois, 60302
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Karen Kim, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-09
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-02-09
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Cancer