Clinical trial NCT05246839: Informed Choice - Compass
Official title: Informed Choice Intervention for Colorectal Cancer Screening: Compass
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: CRC Screening
Colonoscopy
FIT
Cologuard
Screening Modality
Survey
Video
sDNA-FIT
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
name: University of Utah
name: American Cancer Society, Inc.
name: F!ght Colorectal Cancer
First posted: 2022-02-18
Enrollment: 1851
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of Brief Videos
timeFrame: 1 year
Secondary outcomes:
measure: Participant Screening Preferences
timeFrame: 1 year
Other outcomes:
measure: Exploratory Objective- Participant
timeFrame: 1 year
measure: Exploratory Objective- Provider
timeFrame: 1 year
Locations:
city: Phoenix
country: United States
facility: Absolute Clinical Research
state: Arizona
city: Los Angeles
country: United States
facility: Biopharma Informatic
state: California
city: Port Hueneme
country: United States
facility: Saviers Medical Group
state: California
city: Aurora
country: United States
facility: Skylight Health Group
state: Colorado
city: Jacksonville
country: United States
facility: Skylight Health Group
state: Florida
city: Miami
country: United States
facility: I.V.A.M Clinical & Investigational Center
state: Florida
city: Miami
country: United States
facility: ITB Research
state: Florida
city: Panama City
country: United States
facility: Emerald Coast OBGYN
state: Florida
city: Columbus
country: United States
facility: ClinCept, LLC
state: Georgia
city: Marietta
country: United States
facility: Pivotal Clinical Research & Associates, LLC
state: Georgia
city: Suwanee
country: United States
facility: Herman Clinical Research, LLC
state: Georgia
city: Chicago
country: United States
facility: Sheridan Medical Center, S.C
state: Illinois
city: New Orleans
country: United States
facility: Ascension DePaul Community Services of New Orleans
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine
state: Maryland
city: Rockville
country: United States
facility: Advanced Primary and Geriatric Care
state: Maryland
city: Saginaw
country: United States
facility: Valley Ob-Gyn Clinic, PC
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Medical Professionals
state: Missouri
city: La Vista
country: United States
facility: Barrett Clinic
state: Nebraska
city: Jersey City
country: United States
facility: Alliance Community Healthcare, INC
state: New Jersey
city: Union City
country: United States
facility: North Hudson Community Action Corporation
state: New Jersey
city: Brooklyn
country: United States
facility: Ellipsis Research Group, LLC
state: New York
city: Niagara Falls
country: United States
facility: Niagara Falls Memorial Medical Center
state: New York
city: Rosedale
country: United States
facility: Laurelton Heart Specialist PC
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Oklahoma
country: United States
facility: Hightower Clinical OKC
state: Oklahoma
city: Harrisburg
country: United States
facility: Skylight Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mercado Medical Practice
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Medical Specialists Inc
state: Pennsylvania
city: Providence
country: United States
facility: Center for Medical Research, LLC
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: SPICA Clinical Research
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Houston
country: United States
facility: Clear Brook Medical Associates
state: Texas
city: Pharr
country: United States
facility: BioPharma Informatic
state: Texas
city: Spring
country: United States
facility: Valena Medical Research
state: Texas
city: Sugarland
country: United States
facility: A & U Family Medicine
state: Texas
city: Pleasant View
country: United States
facility: Ogden Clinic - Mountain View
state: Utah
city: Roy
country: United States
facility: Ogden Clinic - Grand View
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine
state: Utah
Study officials:
affiliation: Mayo Clinic College of Medicine
name: Joan M. Griffin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: John Inadomi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rogers Solutions Group
name: Charles R. Rogers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.