Study Stopped
Business decision to terminate the study early. Primary endpoint will not be assessed.
Informed Choice - Compass
Informed Choice Intervention for Colorectal Cancer Screening: Compass
1 other identifier
observational
1,823
1 country
39
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. The results will not be posted because the study terminated early and the primary endpoint was not analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedNovember 10, 2025
November 1, 2025
2.8 years
January 24, 2022
November 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of Brief Videos
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.
1 year
Secondary Outcomes (1)
Participant Screening Preferences
1 year
Other Outcomes (2)
Exploratory Objective- Participant
1 year
Exploratory Objective- Provider
1 year
Study Arms (3)
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.
Arm 2 - Brief Video
Participant will watch a video pertaining to the importance of CRC 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.
Interventions
Videos about colorectal cancer screening and modalities.
Eligibility Criteria
Subjects will be 45 to 70 years of age, inclusive, who are scheduled for a primary care appointment, at average risk for colorectal cancer (CRC), and due for CRC screening. The study will enroll approximately 1,851 subjects.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exact Sciences Corporationlead
- Mayo Cliniccollaborator
- University of Utahcollaborator
- American Cancer Society, Inc.collaborator
- F!ght Colorectal Cancercollaborator
Study Sites (39)
Absolute Clinical Research
Phoenix, Arizona, 85323, United States
Biopharma Informatic
Los Angeles, California, 90035, United States
Saviers Medical Group
Port Hueneme, California, 93041, United States
Skylight Health Group
Aurora, Colorado, 80012, United States
Skylight Health Group
Jacksonville, Florida, 32218, United States
I.V.A.M Clinical & Investigational Center
Miami, Florida, 33144, United States
ITB Research
Miami, Florida, 33173, United States
Emerald Coast OBGYN
Panama City, Florida, 32405, United States
ClinCept, LLC
Columbus, Georgia, 31904, United States
Pivotal Clinical Research & Associates, LLC
Marietta, Georgia, 30062, United States
Herman Clinical Research, LLC
Suwanee, Georgia, 30013, United States
Sheridan Medical Center, S.C
Chicago, Illinois, 60613, United States
Ascension DePaul Community Services of New Orleans
New Orleans, Louisiana, 70118, United States
Annapolis Internal Medicine
Annapolis, Maryland, 21401, United States
Advanced Primary and Geriatric Care
Rockville, Maryland, 20850, United States
Valley Ob-Gyn Clinic, PC
Saginaw, Michigan, 48602, United States
St. Louis Medical Professionals
St Louis, Missouri, 63119, United States
Barrett Clinic
La Vista, Nebraska, 68128, United States
Alliance Community Healthcare, INC
Jersey City, New Jersey, 07302, United States
North Hudson Community Action Corporation
Union City, New Jersey, 07087, United States
Ellipsis Research Group, LLC
Brooklyn, New York, 11215, United States
Niagara Falls Memorial Medical Center
Niagara Falls, New York, 14304, United States
Laurelton Heart Specialist PC
Rosedale, New York, 11422, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28208, United States
Hightower Clinical OKC
Oklahoma City, Oklahoma, 73134, United States
Skylight Health
Harrisburg, Pennsylvania, 17109, United States
Mercado Medical Practice
Philadelphia, Pennsylvania, 19111, United States
Pottstown Medical Specialists Inc
Pottstown, Pennsylvania, 19464, United States
Center for Medical Research, LLC
Providence, Rhode Island, 02908, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
SPICA Clinical Research
Columbia, South Carolina, 29322, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305, United States
Clear Brook Medical Associates
Houston, Texas, 77089, United States
BioPharma Informatic
Pharr, Texas, 78577, United States
Valena Medical Research
Spring, Texas, 77379, United States
A & U Family Medicine
Sugarland, Texas, 77479, United States
Ogden Clinic - Mountain View
Pleasant View, Utah, 84404, United States
Ogden Clinic - Grand View
Roy, Utah, 84067, United States
South Ogden Family Medicine
South Ogden, Utah, 84405, United States
Related Publications (1)
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.
PMID: 35842109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan M. Griffin, PhD
Mayo Clinic College of Medicine
- PRINCIPAL INVESTIGATOR
John Inadomi, MD
University of Utah
- PRINCIPAL INVESTIGATOR
Charles R. Rogers, PhD
Rogers Solutions Group
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2022
First Posted
February 18, 2022
Study Start
April 28, 2022
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor. For IPD related to Exact Sciences clinical studies, the Clinical Affairs department will include the policy description and access criteria described above with study-specific postings on clinicaltrials.gov.
Individual participant data that underlie the results reported in publications of the study may be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and clinical study report (when applicable) may also be shared. Data will be available from 2 years and ending 4 years after publication. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.