Informed Choice - Compass

Last updated: October 10, 2024
Sponsor: Exact Sciences Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Rectal Cancer

Treatment

Brief Video

Brief Video Plus

Clinical Study ID

NCT05246839
2019-02
  • Ages 45-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 toparticipate in the study and authorization for release of relevant protected healthinformation (PHI) to the study Investigator.

  4. Participant has never been screened for CRC.

Exclusion

Exclusion Criteria:

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

  2. Participant is due for CRC screening within three months and is already scheduledfor colonoscopy.

  3. Participant has a personal history of CRC or colonic adenomatous or sessile serratedpolyps.

  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-degreerelative diagnosed prior to age 60 and/or at least 2 first-degree relativesdiagnosed with CRC at any age.

  6. Participant has a personal diagnosis or family history of any of the followingconditions:

  7. Familial adenomatous polyposis (also referred to as "FAP", including attenuatedFAP and Gardner's syndrome),

  8. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "LynchSyndrome"),

  9. Other hereditary cancer syndromes including, but are not limited toPeutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's)Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or FamilialHyperplastic Polyposis.

  10. Participant has a diagnosis of Cronkhite-Canada Syndrome.

  11. Participant is current with CRC screening, including gFOBT or FIT within thepreceding 12 months, Cologuard within the preceding 3 years, flexible sigmoidoscopyor 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.

  12. Participant has any condition that in the opinion of the Investigators shouldpreclude participation in the study, including comorbid illnesses precludingendoscopic evaluation or that limit life expectancy to less than 10 years.

Study Design

Total Participants: 1851
Treatment Group(s): 2
Primary Treatment: Brief Video
Phase:
Study Start date:
April 28, 2022
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Absolute Clinical Research

    Phoenix, Arizona 85323
    United States

    Site Not Available

  • Biopharma Informatic

    Los Angeles, California 90035
    United States

    Site Not Available

  • Saviers Medical Group

    Port Hueneme, California 93041
    United States

    Site Not Available

  • Skylight Health Group

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Skylight Health Group

    Jacksonville, Florida 32218
    United States

    Site Not Available

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

    Miami, Florida 33144
    United States

    Site Not Available

  • ITB Research

    Miami, Florida 33173
    United States

    Site Not Available

  • Emerald Coast OBGYN

    Panama City, Florida 32405
    United States

    Site Not Available

  • ClinCept, LLC

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Pivotal Clinical Research & Associates, LLC

    Marietta, Georgia 30062
    United States

    Site Not Available

  • Herman Clinical Research, LLC

    Suwanee, Georgia 30013
    United States

    Site Not Available

  • Sheridan Medical Center, S.C

    Chicago, Illinois 60613
    United States

    Site Not Available

  • Ascension DePaul Community Services of New Orleans

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • Annapolis Internal Medicine

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Advanced Primary and Geriatric Care

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Valley Ob-Gyn Clinic, PC

    Saginaw, Michigan 48602
    United States

    Site Not Available

  • St. Louis Medical Professionals

    Saint Louis, Missouri 63119
    United States

    Site Not Available

  • Barrett Clinic

    La Vista, Nebraska 68128
    United States

    Site Not Available

  • Alliance Community Healthcare, INC

    Jersey City, New Jersey 07302
    United States

    Site Not Available

  • North Hudson Community Action Corporation

    Union City, New Jersey 07087
    United States

    Site Not Available

  • Ellipsis Research Group, LLC

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Niagara Falls Memorial Medical Center

    Niagara Falls, New York 14304
    United States

    Site Not Available

  • Laurelton Heart Specialist PC

    Rosedale, New York 11422
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina 28208
    United States

    Site Not Available

  • Hightower Clinical OKC

    Oklahoma, Oklahoma 73134
    United States

    Site Not Available

  • Hightower Clinical OKC

    Oklahoma City, Oklahoma 73134
    United States

    Site Not Available

  • Skylight Health

    Harrisburg, Pennsylvania 17109
    United States

    Site Not Available

  • Mercado Medical Practice

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Pottstown Medical Specialists Inc

    Pottstown, Pennsylvania 19464
    United States

    Site Not Available

  • Center for Medical Research, LLC

    Providence, Rhode Island 02908
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • SPICA Clinical Research

    Columbia, South Carolina 29322
    United States

    Site Not Available

  • The Jackson Clinic, PA

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Clear Brook Medical Associates

    Houston, Texas 77089
    United States

    Site Not Available

  • Family Practice Center

    McAllen, Texas 78501
    United States

    Site Not Available

  • BioPharma Informatic

    Pharr, Texas 78577
    United States

    Site Not Available

  • Valena Medical Research

    Spring, Texas 77379
    United States

    Site Not Available

  • A & U Family Medicine

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • A & U Family Medicine

    Sugarland, Texas 77479
    United States

    Site Not Available

  • Ogden Clinic - Mountain View

    Pleasant View, Utah 84404
    United States

    Site Not Available

  • Ogden Clinic - Grand View

    Roy, Utah 84067
    United States

    Site Not Available

  • South Ogden Family Medicine

    South Ogden, Utah 84405
    United States

    Site Not Available

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