Informed Choice - Compass
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Arm 1 - Usual Care (No Video) 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. |
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| Arm 2 - Brief Video Subjects will watch a video pertaining to the importance of CRC screening. |
Behavioral: Brief Video
Videos about colorectal cancer screening.
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| Arm 3 - Brief Video Plus 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. |
Behavioral: Brief Video Plus
Videos about colorectal cancer screening and modalities.
|
Outcome Measures
Primary Outcome Measures
- Impact of Brief Videos [1 year]
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.
- Impact of Brief Videos [3 years]
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.
- Impact of Brief Videos [6 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is 45 to 70 years of age, inclusive.
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Subject presents for a primary care appointment.
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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:
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Subject has symptoms or signs that require immediate, or near term referral for diagnostic or therapeutic colonoscopy.
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Subject has a personal history of colorectal cancer (CRC) or colonic adenomatous or sessile serrated polyps.
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Subject has a personal history of inflammatory bowel disease.
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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.
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Subject has a personal diagnosis or family history of any of the following conditions:
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Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
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Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
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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.
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Subject has a diagnosis of Cronkhite-Canada Syndrome
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Biopharma Informatic | Los Angeles | California | United States | 90035 |
| 2 | Saviers Medical Group | Port Hueneme | California | United States | 93041 |
| 3 | ITB Research | Miami | Florida | United States | 33173 |
| 4 | Center for Medical Research, LLC | Providence | Rhode Island | United States | 02908 |
| 5 | Clear Brook Medical Associates | Houston | Texas | United States | 77089 |
| 6 | Family Practice Center | McAllen | Texas | United States | 78501 |
Sponsors and Collaborators
- Exact Sciences Corporation
- Mayo Clinic
- University of Utah
- American Cancer Society, Inc.
- F!ght Colorectal Cancer
Investigators
- Principal Investigator: Joan M. Griffin, PhD, Mayo Clinic College of Medicine
- Principal Investigator: John Inadomi, MD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-02