Informed Choice - Compass

Exact Sciences Corporation

Status: Active, not recruiting

Conditions: Colorectal Cancer

Treatments: Behavioral: Brief Video; Behavioral: Brief Video Plus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05246839

2019-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,280 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

5,280 participants in 3 patient groups

Arm 1 - Usual Care (No Video)

Description:

Subjects 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.

Arm 2 - Brief Video

Description:

Subjects will watch a video pertaining to the importance of CRC screening.

Treatment:

Behavioral: Brief Video

Arm 3 - Brief Video Plus

Description:

Subjects 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.

Treatment:

Behavioral: Brief Video Plus