Informed Choice - Compass

Informed Choice Intervention for Colorectal Cancer Screening: Compass

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Brief Video; Behavioral: Brief Video Plus

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.

• Study Type: Observational
• Enrollment (Actual): 1823

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85323
      • Absolute Clinical Research
  • California
    • Los Angeles, California, United States, 90035
      • Biopharma Informatic
    • Port Hueneme, California, United States, 93041
      • Saviers Medical Group
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Skylight Health Group
  • Florida
    • Jacksonville, Florida, United States, 32218
      • Skylight Health Group
    • Miami, Florida, United States, 33173
      • ITB Research
    • Miami, Florida, United States, 33144
      • I.V.A.M Clinical & Investigational Center
    • Panama City, Florida, United States, 32405
      • Emerald Coast OBGYN
  • Georgia
    • Columbus, Georgia, United States, 31904
      • ClinCept, LLC
    • Marietta, Georgia, United States, 30062
      • Pivotal Clinical Research & Associates, LLC
    • Suwanee, Georgia, United States, 30013
      • Herman Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60613
      • Sheridan Medical Center, S.C
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Ascension DePaul Community Services of New Orleans
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Annapolis Internal Medicine
    • Rockville, Maryland, United States, 20850
      • Advanced Primary and Geriatric Care
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Valley Ob-Gyn Clinic, PC
  • Missouri
    • St Louis, Missouri, United States, 63119
      • St. Louis Medical Professionals
  • Nebraska
    • La Vista, Nebraska, United States, 68128
      • Barrett Clinic
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Alliance Community Healthcare, INC
    • Union City, New Jersey, United States, 07087
      • North Hudson Community Action Corporation
  • New York
    • Brooklyn, New York, United States, 11215
      • Ellipsis Research Group, LLC
    • Niagara Falls, New York, United States, 14304
      • Niagara Falls Memorial Medical Center
    • Rosedale, New York, United States, 11422
      • Laurelton Heart Specialist PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Onsite Clinical Solutions, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Hightower Clinical OKC
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17109
      • Skylight Health
    • Philadelphia, Pennsylvania, United States, 19111
      • Mercado Medical Practice
    • Pottstown, Pennsylvania, United States, 19464
      • Pottstown Medical Specialists Inc
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Center for Medical Research, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29322
      • SPICA Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
  • Texas
    • Houston, Texas, United States, 77089
      • Clear Brook Medical Associates
    • Pharr, Texas, United States, 78577
      • Biopharma Informatic
    • Spring, Texas, United States, 77379
      • Valena Medical Research
    • Sugarland, Texas, United States, 77479
      • A & U Family Medicine
  • Utah
    • Pleasant View, Utah, United States, 84404
      • Ogden Clinic - Mountain View
    • Roy, Utah, United States, 84067
      • Ogden Clinic - Grand View
    • South Ogden, Utah, United States, 84405
      • South Ogden Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Participant is 45 to 70 years of age, inclusive.
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:

1. Participant has symptoms or signs that require immediate, or near-term referral for diagnostic or therapeutic colonoscopy.
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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: 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.	Behavioral: Brief Video Plus; Videos about colorectal cancer screening and modalities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Screening Preferences	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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Objective- Participant	Evaluate participant knowledge, attitudes, and intentions related to CRC screening and assess personal and environmental factors associated with screening intentions and completion by modality.	1 year
Exploratory Objective- Provider	Characterize provider, system, and site-level factors associated with CRC screening rates and use of various screening modalities at different times throughout the intervention (prior to and after recruitment is completed).	1 year

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation
• Collaborators: Mayo Clinic; University of Utah; American Cancer Society, Inc.; F!ght Colorectal Cancer
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Survey; Colonoscopy; Video; CRC Screening; FIT; Cologuard; Screening Modality; sDNA-FIT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No