Colorectal Cancer
Conditions
Keywords
CRC Screening, Colonoscopy, FIT, Cologuard, Screening Modality, Survey, Video, sDNA-FIT
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. The results will not be posted because the study terminated early and the primary endpoint was not analyzed.
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.
Interventions
BEHAVIORALBrief Video
Videos about colorectal cancer screening.
BEHAVIORALBrief Video Plus
Videos about colorectal cancer screening and modalities.
Sponsors
Mayo Clinic
University of Utah
American Cancer Society, Inc.
F!ght Colorectal Cancer
Exact Sciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Objective- Participant | 1 year | Evaluate participant knowledge, attitudes, and intentions related to CRC screening and assess personal and environmental factors associated with screening intentions and completion by modality. |
| Exploratory Objective- Provider | 1 year | Characterize provider, system, and site-level factors associated with CRC screening rates and use of various screening modalities at different times throughout the intervention (prior to and after recruitment is completed). |
Countries
United States
Outcome results
None listed