Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1823 participants
OBSERVATIONAL
2022-04-28
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm 1 - Usual Care (No Video)
Participant will receive the usual care pertaining to colorectal cancer (CRC) screening according to their respective clinical site and will not view either of the study videos.
No interventions assigned to this group
Arm 2 - Brief Video
Participant will watch a video pertaining to the importance of CRC screening.
Brief Video
Videos about colorectal cancer screening.
Arm 3 - Brief Video Plus
Participant will watch the same video as described in Arm 2, immediately followed by a second video pertaining to 3 CRC screening modalities: colonoscopy, FIT, and Cologuard.
Brief Video Plus
Videos about colorectal cancer screening and modalities.
Interventions
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Brief Video
Videos about colorectal cancer screening.
Brief Video Plus
Videos about colorectal cancer screening and modalities.
Eligibility Criteria
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Inclusion Criteria
2. Participant presents for a primary care appointment.
3. 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.
4. Participant has never been screened for CRC.
Exclusion Criteria
2. Participant is due for CRC screening within three months and is already scheduled for colonoscopy.
3. Participant has a personal history of CRC or colonic adenomatous or sessile serrated polyps.
4. Participant has a personal history of inflammatory bowel disease.
5. 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.
6. Participant has a personal diagnosis or family history of any of the following conditions:
1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
3. 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.
7. Participant has a diagnosis of Cronkhite-Canada Syndrome.
8. 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.
9. 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.
45 Years
70 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
University of Utah
OTHER
American Cancer Society, Inc.
OTHER
F!ght Colorectal Cancer
UNKNOWN
Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Joan M. Griffin, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic College of Medicine
John Inadomi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Charles R. Rogers, PhD
Role: PRINCIPAL_INVESTIGATOR
Rogers Solutions Group
Locations
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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
Skylight Health
Harrisburg, Pennsylvania, United States
Mercado Medical Practice
Philadelphia, Pennsylvania, United States
Pottstown Medical Specialists Inc
Pottstown, Pennsylvania, United States
Center for Medical Research, LLC
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
SPICA Clinical Research
Columbia, South Carolina, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Clear Brook Medical Associates
Houston, Texas, United States
BioPharma Informatic
Pharr, Texas, United States
Valena Medical Research
Spring, Texas, United States
A & U Family Medicine
Sugarland, Texas, United States
Ogden Clinic - Mountain View
Pleasant View, Utah, United States
Ogden Clinic - Grand View
Roy, Utah, United States
South Ogden Family Medicine
South Ogden, Utah, United States
Countries
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References
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Griffin JM, Finney Rutten LJ, Zhu X, Feng Z, Rogers CR, Marsh TL, Inadomi JM. The COMPASS study: A prospective, randomized, multi-center trial testing the impact of a clinic-based intervention informing patients of colorectal cancer screening options on screening completion. Contemp Clin Trials. 2022 Aug;119:106852. doi: 10.1016/j.cct.2022.106852. Epub 2022 Jul 13.
Other Identifiers
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2019-02
Identifier Type: -
Identifier Source: org_study_id