Informed Choice - Compass

Active, not recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT05246839
• Lead Sponsor: Exact Sciences Corporation

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.

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-18
• Study Start: 2022-04-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1851

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of Brief Videos	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Participant Screening Preferences	1 year	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.

Trial Locations

Locations (38)

Absolute Clinical Research; 🇺🇸 Phoenix, Arizona, United States

Biopharma Informatic; 🇺🇸 Los Angeles, California, United States

Saviers Medical Group; 🇺🇸 Port Hueneme, California, United States

Skylight Health Group; 🇺🇸 Jacksonville, Florida, United States

I.V.A.M Clinical & Investigational Center; 🇺🇸 Miami, Florida, United States

ITB Research; 🇺🇸 Miami, Florida, United States

Emerald Coast OBGYN; 🇺🇸 Panama City, Florida, United States

ClinCept, LLC; 🇺🇸 Columbus, Georgia, United States

Pivotal Clinical Research & Associates, LLC; 🇺🇸 Marietta, Georgia, United States

Herman Clinical Research, LLC; 🇺🇸 Suwanee, Georgia, United States

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