Informed Choice - Compass

Stopped early

Conditions studied: Colorectal Cancer

In brief

The primary objective of this study is to evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices on CRC screening rates and time adherent to CRC guidelines. The results will not be posted because the study terminated early and the primary endpoint was not analyzed.

Key facts

Study ID

NCT05246839

Run by

Exact Sciences Corporation

People needed

1823

Starts

2022-04-28

Expected to finish

2025-01-31

Last updated by the study team

2025-11-10

Who can join

Age: 45 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant is 45 to 70 years of age, inclusive.
• Participant presents for a primary care appointment.
• Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information (PHI) to the study Investigator.
• Participant has never been screened for CRC.

You may not qualify if…

• Participant has symptoms or signs that require immediate, or near-term referral for diagnostic or therapeutic colonoscopy.
• Participant is due for CRC screening within three months and is already scheduled for colonoscopy.
• Participant has a personal history of CRC or colonic adenomatous or sessile serrated polyps.
• Participant has a personal history of inflammatory bowel disease.
• Participant has a family history of CRC in at least one first- or second-degree relative diagnosed prior to age 60 and/or at least 2 first-degree relatives diagnosed with CRC at any age.
• Participant has a personal diagnosis or family history of any of the following conditions:
• Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
• Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
• Other hereditary cancer syndromes including, but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
• Participant has a diagnosis of Cronkhite-Canada Syndrome.
• Participant is current with CRC screening, including gFOBT or FIT within the preceding 12 months, Cologuard within the preceding 3 years, flexible sigmoidoscopy or CT colonography within the preceding 5 years, or colonoscopy within the preceding 10 years. Participants can be enrolled up to 3 months prior to screening due date.
• Participant has any condition that in the opinion of the Investigators should preclude participation in the study, including comorbid illnesses precluding endoscopic evaluation or that limit life expectancy to less than 10 years.

Where it is running

• Absolute Clinical Research — Phoenix, Arizona, United States
• Biopharma Informatic — Los Angeles, California, United States
• Saviers Medical Group — Port Hueneme, California, United States
• Skylight Health Group — Aurora, Colorado, United States
• Skylight Health Group — Jacksonville, Florida, United States
• I.V.A.M Clinical & Investigational Center — Miami, Florida, United States
• ITB Research — Miami, Florida, United States
• Emerald Coast OBGYN — Panama City, Florida, United States
• ClinCept, LLC — Columbus, Georgia, United States
• Pivotal Clinical Research & Associates, LLC — Marietta, Georgia, United States
• Herman Clinical Research, LLC — Suwanee, Georgia, United States
• Sheridan Medical Center, S.C — Chicago, Illinois, United States
• Ascension DePaul Community Services of New Orleans — New Orleans, Louisiana, United States
• Annapolis Internal Medicine — Annapolis, Maryland, United States
• Advanced Primary and Geriatric Care — Rockville, Maryland, United States
• Valley Ob-Gyn Clinic, PC — Saginaw, Michigan, United States
• St. Louis Medical Professionals — St Louis, Missouri, United States
• Barrett Clinic — La Vista, Nebraska, United States
• Alliance Community Healthcare, INC — Jersey City, New Jersey, United States
• North Hudson Community Action Corporation — Union City, New Jersey, United States
• Ellipsis Research Group, LLC — Brooklyn, New York, United States
• Niagara Falls Memorial Medical Center — Niagara Falls, New York, United States
• Laurelton Heart Specialist PC — Rosedale, New York, United States
• OnSite Clinical Solutions, LLC — Charlotte, North Carolina, United States
• Hightower Clinical OKC — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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