Informed Choice - Compass

NCT ID: NCT05246839

Last Updated: 2025-11-10

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

1823 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-28

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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CRC Screening Colonoscopy FIT Cologuard Screening Modality Survey Video sDNA-FIT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Videos about colorectal cancer screening and modalities.

Interventions

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Brief Video

Videos about colorectal cancer screening.

Intervention Type BEHAVIORAL

Brief Video Plus

Videos about colorectal cancer screening and modalities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

F!ght Colorectal Cancer

UNKNOWN

Sponsor Role collaborator

Exact Sciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Biopharma Informatic

Los Angeles, California, United States

Site Status

Saviers Medical Group

Port Hueneme, California, United States

Site Status

Skylight Health Group

Aurora, Colorado, United States

Site Status

Skylight Health Group

Jacksonville, Florida, United States

Site Status

I.V.A.M Clinical & Investigational Center

Miami, Florida, United States

Site Status

ITB Research

Miami, Florida, United States

Site Status

Emerald Coast OBGYN

Panama City, Florida, United States

Site Status

ClinCept, LLC

Columbus, Georgia, United States

Site Status

Pivotal Clinical Research & Associates, LLC

Marietta, Georgia, United States

Site Status

Herman Clinical Research, LLC

Suwanee, Georgia, United States

Site Status

Sheridan Medical Center, S.C

Chicago, Illinois, United States

Site Status

Ascension DePaul Community Services of New Orleans

New Orleans, Louisiana, United States

Site Status

Annapolis Internal Medicine

Annapolis, Maryland, United States

Site Status

Advanced Primary and Geriatric Care

Rockville, Maryland, United States

Site Status

Valley Ob-Gyn Clinic, PC

Saginaw, Michigan, United States

Site Status

St. Louis Medical Professionals

St Louis, Missouri, United States

Site Status

Barrett Clinic

La Vista, Nebraska, United States

Site Status

Alliance Community Healthcare, INC

Jersey City, New Jersey, United States

Site Status

North Hudson Community Action Corporation

Union City, New Jersey, United States

Site Status

Ellipsis Research Group, LLC

Brooklyn, New York, United States

Site Status

Niagara Falls Memorial Medical Center

Niagara Falls, New York, United States

Site Status

Laurelton Heart Specialist PC

Rosedale, New York, United States

Site Status

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, United States

Site Status

Hightower Clinical OKC

Oklahoma City, Oklahoma, United States

Site Status

Skylight Health

Harrisburg, Pennsylvania, United States

Site Status

Mercado Medical Practice

Philadelphia, Pennsylvania, United States

Site Status

Pottstown Medical Specialists Inc

Pottstown, Pennsylvania, United States

Site Status

Center for Medical Research, LLC

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

SPICA Clinical Research

Columbia, South Carolina, United States

Site Status

The Jackson Clinic, PA

Jackson, Tennessee, United States

Site Status

Clear Brook Medical Associates

Houston, Texas, United States

Site Status

BioPharma Informatic

Pharr, Texas, United States

Site Status

Valena Medical Research

Spring, Texas, United States

Site Status

A & U Family Medicine

Sugarland, Texas, United States

Site Status

Ogden Clinic - Mountain View

Pleasant View, Utah, United States

Site Status

Ogden Clinic - Grand View

Roy, Utah, United States

Site Status

South Ogden Family Medicine

South Ogden, Utah, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 35842109 (View on PubMed)

Other Identifiers

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2019-02

Identifier Type: -

Identifier Source: org_study_id