Informed Choice - Compass
- Conditions
- Colorectal Cancer
- Interventions
- Behavioral: Brief VideoBehavioral: Brief Video Plus
- Registration Number
- NCT05246839
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
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.
- Detailed Description
Participants 45 to 70 years of age, scheduled for a primary care (index) appointment, at average risk for colorectal cancer (CRC), and due for CRC screening will be enrolled in the study. Participants will be randomized to one of three intervention arms: no video (arm 1), brief CRC screening video (arm 2), or enhanced CRC screening video (arm 3). Participants in all intervention arms will complete surveys regarding intention to screen for CRC and preference for screening modality prior to viewing the video, after the video, and after their index appointment. Participants will be surveyed, and medical information collected, for 1 year after randomization to assess adherence to CRC screening and CRC screening outcomes.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1851
- 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.
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Participant has symptoms or signs that require immediate, or near-term referral for diagnostic or therapeutic colonoscopy.
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Participant is due for CRC screening within three months and is already scheduled for colonoscopy.
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Participant has a personal history of CRC or colonic adenomatous or sessile serrated polyps.
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Participant has a personal history of inflammatory bowel disease.
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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.
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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.
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Participant has a diagnosis of Cronkhite-Canada Syndrome.
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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.
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm 2 - Brief Video Brief Video Subjects will watch a video pertaining to the importance of CRC screening. Arm 3 - Brief Video Plus Brief Video Plus Subjects 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.
- Primary Outcome Measures
Name Time Method Impact of Brief Videos 1 year To evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices (colonoscopy, FIT, and Cologuard) on CRC screening rates and the proportion of time adherent to CRC guidelines.
- Secondary Outcome Measures
Name Time Method Participant Screening Preferences 1 year To examine initial mode preferences between participants viewing a theoretically grounded video that includes information about CRC screening modality choices (colonoscopy, FIT, and Cologuard) compared to those receiving only a brief informational video about CRC screening or receiving only usual care.
Trial Locations
- Locations (38)
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
🇺🇸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
🇺🇸Saint 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, 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