Informed Choice - Compass

Colorectal Cancer Clinical Trial

Official title:

Informed Choice Intervention for Colorectal Cancer Screening: Compass

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05246839
• Other study ID #: 2019-02
• Status: Active, not recruiting
• Start date: April 28, 2022
• Est. completion date: March 2029

Study information

• Verified date: June 2024
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

Subjects 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. Subjects 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). Subjects 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. Subjects will be surveyed, and medical information collected, annually for up to six years to assess adherence to CRC screening and CRC screening outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5280
• Est. completion date: March 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subject is 45 to 70 years of age, inclusive.

2. Subject presents for a primary care appointment.

3. Subject 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.

Exclusion Criteria:

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

2. Subject has a personal history of colorectal cancer (CRC) or colonic adenomatous or sessile serrated polyps.

3. Subject has a personal history of inflammatory bowel disease.

4. Subject 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.

5. Subject 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.

6. Subject has a diagnosis of Cronkhite-Canada Syndrome

7. Subject 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. Subjects can be enrolled up to 3 months prior to screening due date.

8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study, including comorbid illnesses precluding endoscopic evaluation or that limit life expectancy to less than 10 years.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Brief Video
Videos about colorectal cancer screening.
• Brief Video Plus
Videos about colorectal cancer screening and modalities.

Locations

Country	Name	City	State
United States	Annapolis Internal Medicine	Annapolis	Maryland
United States	Skylight Health Group	Aurora	Colorado
United States	Ellipsis Research Group, LLC	Brooklyn	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Sheridan Medical Center, S.C	Chicago	Illinois
United States	SPICA Clinical Research	Columbia	South Carolina
United States	ClinCept, LLC	Columbus	Georgia
United States	Skylight Health	Harrisburg	Pennsylvania
United States	Clear Brook Medical Associates	Houston	Texas
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Skylight Health Group	Jacksonville	Florida
United States	Alliance Community Healthcare, INC	Jersey City	New Jersey
United States	Barrett Clinic	La Vista	Nebraska
United States	Biopharma Informatic	Los Angeles	California
United States	Pivotal Clinical Research & Associates, LLC	Marietta	Georgia
United States	I.V.A.M Clinical & Investigational Center	Miami	Florida
United States	ITB Research	Miami	Florida
United States	Ascension DePaul Community Services of New Orleans	New Orleans	Louisiana
United States	Niagara Falls Memorial Medical Center	Niagara Falls	New York
United States	Hightower Clinical OKC	Oklahoma City	Oklahoma
United States	Emerald Coast OBGYN	Panama City	Florida
United States	BioPharma Informatic	Pharr	Texas
United States	Mercado Medical Practice	Philadelphia	Pennsylvania
United States	Absolute Clinical Research	Phoenix	Arizona
United States	Ogden Clinic - Mountain View	Pleasant View	Utah
United States	Saviers Medical Group	Port Hueneme	California
United States	Pottstown Medical Specialists Inc	Pottstown	Pennsylvania
United States	Center for Medical Research, LLC	Providence	Rhode Island
United States	Advanced Primary and Geriatric Care	Rockville	Maryland
United States	Laurelton Heart Specialist PC	Rosedale	New York
United States	Ogden Clinic - Grand View	Roy	Utah
United States	Valley Ob-Gyn Clinic, PC	Saginaw	Michigan
United States	St. Louis Medical Professionals	Saint Louis	Missouri
United States	South Ogden Family Medicine	South Ogden	Utah
United States	Valena Medical Research	Spring	Texas
United States	A & U Family Medicine	Sugar Land	Texas
United States	Herman Clinical Research, LLC	Suwanee	Georgia
United States	North Hudson Community Action Corporation	Union City	New Jersey

Sponsors (5)

Lead Sponsor	Collaborator
Exact Sciences Corporation	American Cancer Society, Inc., F!ght Colorectal Cancer, Mayo Clinic, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Brief Videos	The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 1 year.	1 year
Primary	Impact of Brief Videos	The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 3 years.	3 years
Primary	Impact of Brief Videos	The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 6 years.	6 years