Colo-rectal Cancer Clinical Trial
— U-ScreenOfficial title:
Understanding Patient Preference on Colorectal Cancer Screening Options
There are significant barriers to colorectal cancer screening within underserved populations due to the cost, accessibility, and acceptability of screening methods. Patient-friendly approaches that minimize stress and discomfort for the patient are needed to enhance screening compliance and achieve an early diagnosis. The primary aim of this study is to examine whether the availability of a blood-based screening option, which can be done at the point of service and is familiar to patients, will improve patient compliance to recommended CRC screening
Status | Not yet recruiting |
Enrollment | 900 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | Inclusion Criteria: To be enrolled in this study, participants must meet all the following criteria: 1. Between 45-75 years of age 2. Language Proficiency: participants must be fluent in English or Spanish 3. Have an average risk for colorectal cancer 4. Be a patient at one of our partner FQHCs 5. Received a screening order (either using a stool-based test or colonoscopy) six months ago and failed or refused to complete the screening test 6. Able and willing to provide a blood sample per protocol Exclusion Criteria: Participants will be excluded from enrolling in the study if they meet any of the following: 1. Family history - One first-degree relative diagnosed with CRC or advanced adenoma at age <60 years - Two first-degree relatives diagnosed with CRC or advanced adenoma at any age - Known hereditary gastrointestinal cancer syndromes, such as Lynch Syndrome or Familial Adenomatous and Polyposis (FAP) 2. Personal History - Participants who do not speak either Spanish or English - History of CRC or adenoma - History of cancers - History of inflammatory bowel disease, including chronic ulcerative colitis and Crohn's disease - Have a recorded up to date CRC screening - Blood product transfusion in the past 120 days - A medical condition which, in the opinion of the patient's health provider, should preclude enrollment in the study |
Country | Name | City | State |
---|---|---|---|
United States | Penn State College of Medicine | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | Guardant Health, Inc., HealthLinc, Inc, PCC Community Wellness Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient preference for a blood-based screening option | We will ask participants the following survey question: "Will you prefer to use the blood-based screening test for future colorectal cancer screening?" Response options range from 0 to 10 where 0 is "not at all" and 10 is "very much". We will split the response options at the median and categorize the measure into a "yes/no" response. | 2023-2025 | |
Secondary | Adoption rate | This study will monitor the adoption rates for Guardant SHIELD blood-based screening over time and how long it takes to achieve 2.5%, 16%, and 50% adoption rates (adoption rate = the number of new users / total number of potential users). We will monitor the adoption rate quarterly. In addition, we will also monitor the intensity of use.
This study will monitor the adoption rates for Guardant SHIELD blood-based screening over time and how long it takes to achieve 2.5%, 16%, and 50% adoption rates (adoption rate = the number of new users / total number of potential users). We will monitor the adoption rate quarterly. In addition, we will also monitor the intensity of use |
2023-2025 |
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