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Colorectal CancerNCT05246839

Informed Choice - Compass

An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 39 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Brief Video and Brief Video Plus
How many people
1,823 participants
Where
39 sitesUnited States
Study dates
28 Apr 2022to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 12Show fewer
  • 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.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Annapolis Internal Medicine

    Annapolis, Maryland, 21401

  • Skylight Health Group

    Aurora, Colorado, 80012

  • Ellipsis Research Group, LLC

    Brooklyn, New York, 11215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28208

  • Sheridan Medical Center, S.C

    Chicago, Illinois, 60613

  • SPICA Clinical Research

    Columbia, South Carolina, 29322

  • ClinCept, LLC

    Columbus, Georgia, 31904

  • Skylight Health

    Harrisburg, Pennsylvania, 17109

  • Clear Brook Medical Associates

    Houston, Texas, 77089

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38305

  • Skylight Health Group

    Jacksonville, Florida, 32218

  • Alliance Community Healthcare, INC

    Jersey City, New Jersey, 07302

  • Barrett Clinic

    La Vista, Nebraska, 68128

  • Biopharma Informatic

    Los Angeles, California, 90035

  • Pivotal Clinical Research & Associates, LLC

    Marietta, Georgia, 30062

  • I.V.A.M Clinical & Investigational Center

    Miami, Florida, 33144

  • ITB Research

    Miami, Florida, 33173

  • Ascension DePaul Community Services of New Orleans

    New Orleans, Louisiana, 70118

  • Niagara Falls Memorial Medical Center

    Niagara Falls, New York, 14304

  • Hightower Clinical OKC

    Oklahoma City, Oklahoma, 73134

  • Emerald Coast OBGYN

    Panama City, Florida, 32405

  • BioPharma Informatic

    Pharr, Texas, 78577

  • Mercado Medical Practice

    Philadelphia, Pennsylvania, 19111

  • Absolute Clinical Research

    Phoenix, Arizona, 85323

  • Ogden Clinic - Mountain View

    Pleasant View, Utah, 84404

  • Saviers Medical Group

    Port Hueneme, California, 93041

  • Pottstown Medical Specialists Inc

    Pottstown, Pennsylvania, 19464

  • Center for Medical Research, LLC

    Providence, Rhode Island, 02908

  • Advanced Primary and Geriatric Care

    Rockville, Maryland, 20850

  • Laurelton Heart Specialist PC

    Rosedale, New York, 11422

  • Ogden Clinic - Grand View

    Roy, Utah, 84067

  • Valley Ob-Gyn Clinic, PC

    Saginaw, Michigan, 48602

  • South Ogden Family Medicine

    South Ogden, Utah, 84405

  • Valena Medical Research

    Spring, Texas, 77379

  • St. Louis Medical Professionals

    St Louis, Missouri, 63119

  • A & U Family Medicine

    Sugarland, Texas, 77479

  • Herman Clinical Research, LLC

    Suwanee, Georgia, 30013

  • North Hudson Community Action Corporation

    Union City, New Jersey, 07087

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Brief Video, Brief Video Plus
Keywords
CRC Screening, Colonoscopy, FIT, Cologuard, Screening Modality, Survey, Video, sDNA-FIT
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief VideoBehavioural

    Videos about colorectal cancer screening.

  • Brief Video PlusBehavioural

    Videos about colorectal cancer screening and modalities.

Study groups in NCT05246839
Study groupRoleWhat they receive
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 VideoParticipant will watch a video pertaining to the importance of CRC screening.
Receives: Behavioral: Brief Video
Arm 3 - Brief Video PlusParticipant 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.
Receives: Behavioral: Brief Video Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start28 Apr 2022
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Why it stopped: Business decision to terminate the study early. Primary endpoint will not be assessed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05246839
Sponsor's protocol ID
2019-02
Status last verified
Nov 2025
First submitted
24 Jan 2022
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 35842109

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business decision to terminate the study early. Primary endpoint will not be assessed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of Brief Videos (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05246839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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Informed Choice - Compass (NCT05246839) | AzTrials