Understanding Patient Preference on Colorectal Cancer Screening Options-PSU

NCT06444542 | Completed

• 1 other identifier: STUDY00023853
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adoption rate

  2023-2025

Interventions

Guardant Shield BEHAVIORAL

Blood-based colorectal cancer screening

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who failed to complete a stool-based screening test or a colonoscopy six months after receiving an order from their providers

You may qualify if:

• To be enrolled in this study, participants must meet all the following criteria:
• Between 45-75 years of age
• Language Proficiency: participants must be fluent in English or Spanish
• Have an average risk for colorectal cancer
• Be 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 and willing to provide a blood sample per protocol

You may not qualify if:

• Participants will be excluded from enrolling in the study if they meet any of the following:
• 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)
• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Guardant Health, Inc.: collaborator
• HealthLinc, Inc: collaborator
• PCC Community Wellness Center: collaborator

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Karen E. Kim, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean at Penn State College of Medicine

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 5, 2024
• Study Start: September 16, 2024
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)